سجل المنتجات المرجعية · 375 مقارنا للتكافؤ الحيوي
Illustrative harmonised register of bioequivalence comparators for the Arab markets. Confirm the definitive comparator with the authority of each market before use. Interactive version: the Register tool.
سجل استرشادي موحد لمقارنات التكافؤ الحيوي للأسواق العربية · يلزم تأكيد المقارن النهائي من سلطة كل سوق قبل الاستخدام.
| ID | Molecule | Form | Comparator | Tier | Recommended approach | Note |
|---|---|---|---|---|---|---|
| S001 | Atorvastatin | Tablet (IR, oral) | Lipitor (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Higher-variability drug |
| S002 | Rosuvastatin | Tablet (IR, oral) | Crestor (AstraZeneca) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S003 | Simvastatin | Tablet (IR, oral) | Zocor (MSD) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S004 | Pravastatin | Tablet (IR, oral) | Pravachol (BMS) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S005 | Fluvastatin | Prolonged-release tablet (oral) | Lescol XL (Novartis) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S006 | Pitavastatin | Tablet (IR, oral) | Livalo (Kowa) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S007 | Ezetimibe | Tablet (IR, oral) | Ezetrol / Zetia (MSD) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S008 | Fenofibrate | Capsule (oral) | Lipanthyl / Tricor (Abbott) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S009 | Gemfibrozil | Tablet (IR, oral) | Lopid (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S010 | Ramipril | Tablet/capsule (IR, oral) | Tritace / Altace (Sanofi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S011 | Enalapril maleate | Tablet (IR, oral) | Renitec / Vasotec (MSD) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S012 | Lisinopril | Tablet (IR, oral) | Zestril / Prinivil (AstraZeneca/MSD) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S013 | Perindopril | Tablet (IR, oral) | Coversyl (Servier) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S014 | Captopril | Tablet (IR, oral) | Capoten (BMS) | A | In vivo bioequivalence (PK), or BCS-based biowaiver where eligible — ICH M13A / ICH M9 | BCS may allow biowaiver |
| S015 | Losartan potassium | Tablet (IR, oral) | Cozaar (MSD) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S016 | Valsartan | Tablet (IR, oral) | Diovan (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S017 | Telmisartan | Tablet (IR, oral) | Micardis (Boehringer Ingelheim) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S018 | Candesartan cilexetil | Tablet (IR, oral) | Atacand (AstraZeneca) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S019 | Irbesartan | Tablet (IR, oral) | Aprovel / Avapro (Sanofi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S020 | Olmesartan medoxomil | Tablet (IR, oral) | Olmetec / Benicar (Daiichi Sankyo) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S021 | Sacubitril / valsartan | Tablet (IR, oral) | Entresto (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S022 | Amlodipine | Tablet (IR, oral) | Norvasc (Pfizer) | A | In vivo bioequivalence (PK), or BCS-based biowaiver where eligible — ICH M13A / ICH M9 | BCS I biowaiver candidate |
| S023 | Nifedipine | Prolonged-release tablet (oral) | Adalat LA (Bayer) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S024 | Felodipine | Prolonged-release tablet (oral) | Plendil (AstraZeneca) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S025 | Lercanidipine | Tablet (IR, oral) | Zanidip (Recordati) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S026 | Diltiazem hydrochloride | Prolonged-release capsule (oral) | Tildiem / Cardizem | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S027 | Verapamil hydrochloride | Prolonged-release tablet (oral) | Isoptin SR (Abbott) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S028 | Bisoprolol fumarate | Tablet (IR, oral) | Concor (Merck) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S029 | Metoprolol succinate | Prolonged-release tablet (oral) | Betaloc ZOK / Toprol-XL (AstraZeneca) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S030 | Metoprolol tartrate | Tablet (IR, oral) | Lopressor (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S031 | Carvedilol | Tablet (IR, oral) | Dilatrend / Coreg (Roche/GSK) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S032 | Nebivolol | Tablet (IR, oral) | Nebilet / Bystolic (Menarini) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S033 | Atenolol | Tablet (IR, oral) | Tenormin (AstraZeneca) | A | In vivo bioequivalence (PK), or BCS-based biowaiver where eligible — ICH M13A / ICH M9 | |
| S034 | Propranolol hydrochloride | Tablet (IR, oral) | Inderal (AstraZeneca) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S035 | Ivabradine | Tablet (IR, oral) | Procoralan / Corlanor (Servier) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S036 | Amiodarone hydrochloride | Tablet (IR, oral) | Cordarone (Sanofi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Long half-life |
| S037 | Digoxin | Tablet (IR, oral) | Lanoxin (Aspen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Narrow therapeutic index |
| S038 | Spironolactone | Tablet (IR, oral) | Aldactone (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S039 | Hydrochlorothiazide | Tablet (IR, oral) | Innovator | A | In vivo bioequivalence (PK), or BCS-based biowaiver where eligible — ICH M13A / ICH M9 | |
| S040 | Indapamide | Prolonged-release tablet (oral) | Natrilix SR (Servier) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S041 | Furosemide | Tablet (IR, oral) | Lasix (Sanofi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S042 | Torasemide | Tablet (IR, oral) | Demadex / Torem | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S043 | Ranolazine | Prolonged-release tablet (oral) | Ranexa (Menarini/Gilead) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S044 | Nitroglycerin (glyceryl trinitrate) | Transdermal patch | Nitro-Dur / Minitran | A | In vivo bioequivalence (PK) + adhesion and skin-tolerability studies | |
| S045 | Isosorbide mononitrate | Prolonged-release tablet (oral) | Imdur (AstraZeneca) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S046 | Clopidogrel bisulfate | Tablet (IR, oral) | Plavix (Sanofi/BMS) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S047 | Ticagrelor | Tablet (IR, oral) | Brilinta / Brilique (AstraZeneca) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S048 | Prasugrel | Tablet (IR, oral) | Efient / Effient (Lilly/Daiichi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S049 | Acetylsalicylic acid | Gastro-resistant tablet (oral) | Aspirin (Bayer) | A | In vivo bioequivalence (PK); gastro-resistant / enteric-coated | |
| S050 | Dipyridamole / aspirin | Modified-release capsule (oral) | Aggrenox / Asasantin (Boehringer) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S051 | Warfarin sodium | Tablet (IR, oral) | Coumadin (BMS) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Narrow therapeutic index |
| S052 | Rivaroxaban | Tablet (IR, oral) | Xarelto (Bayer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S053 | Apixaban | Tablet (IR, oral) | Eliquis (BMS/Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S054 | Dabigatran etexilate | Capsule (oral) | Pradaxa (Boehringer Ingelheim) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S055 | Edoxaban | Tablet (IR, oral) | Lixiana / Savaysa (Daiichi Sankyo) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S056 | Enoxaparin sodium | Solution for injection (LMWH) | Clexane / Lovenox (Sanofi) | A | Physicochemical, structural & functional characterisation ± PK/clinical (complex product) | Complex; LMWH sameness |
| S057 | Heparin sodium | Solution for injection | Innovator | A | Physicochemical, structural & functional characterisation ± PK/clinical (complex product) | Biological-derived |
| S058 | Fondaparinux sodium | Solution for injection | Arixtra (Aspen) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | |
| S059 | Metformin hydrochloride | Tablet (IR, oral) | Glucophage (Merck/BMS) | A | In vivo bioequivalence (PK), or BCS-based biowaiver where eligible — ICH M13A / ICH M9 | BCS III biowaiver may apply |
| S060 | Metformin hydrochloride | Prolonged-release tablet (oral) | Glucophage XR (Merck) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S061 | Gliclazide | Prolonged-release tablet (oral) | Diamicron MR (Servier) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S062 | Glimepiride | Tablet (IR, oral) | Amaryl (Sanofi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S063 | Glibenclamide (glyburide) | Tablet (IR, oral) | Daonil (Sanofi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S064 | Sitagliptin | Tablet (IR, oral) | Januvia (MSD) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S065 | Vildagliptin | Tablet (IR, oral) | Galvus (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S066 | Linagliptin | Tablet (IR, oral) | Trajenta (Boehringer/Lilly) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S067 | Saxagliptin | Tablet (IR, oral) | Onglyza (AstraZeneca) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S068 | Empagliflozin | Tablet (IR, oral) | Jardiance (Boehringer/Lilly) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S069 | Dapagliflozin | Tablet (IR, oral) | Forxiga / Farxiga (AstraZeneca) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S070 | Canagliflozin | Tablet (IR, oral) | Invokana (Janssen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S071 | Pioglitazone | Tablet (IR, oral) | Actos (Takeda) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S072 | Repaglinide | Tablet (IR, oral) | NovoNorm / Prandin (Novo Nordisk) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S073 | Acarbose | Tablet (IR, oral) | Glucobay (Bayer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S074 | Levothyroxine sodium | Tablet (IR, oral) | Euthyrox / Eltroxin (Merck/Aspen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Narrow therapeutic index |
| S075 | Carbimazole | Tablet (IR, oral) | Neo-Mercazole (Amdipharm) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S076 | Cinacalcet | Tablet (IR, oral) | Mimpara / Sensipar (Amgen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S077 | Alendronic acid | Tablet (IR, oral) | Fosamax (MSD) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S078 | Risedronate sodium | Tablet (IR, oral) | Actonel (Allergan) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S079 | Ibandronic acid | Tablet (IR, oral) | Bonviva / Boniva (Roche) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S080 | Prednisolone | Tablet (IR, oral) | Innovator | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S081 | Prednisone | Tablet (IR, oral) | Innovator | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S082 | Dexamethasone | Tablet (IR, oral) | Innovator | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S083 | Hydrocortisone | Tablet (IR, oral) | Innovator | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S084 | Fludrocortisone acetate | Tablet (IR, oral) | Florinef (Aspen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S085 | Estradiol | Transdermal patch | Climara / Estraderm (Bayer/Novartis) | A | In vivo bioequivalence (PK) + adhesion and skin-tolerability studies | |
| S086 | Estradiol / norethisterone | Tablet (IR, oral) | Innovator | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S087 | Testosterone | Transdermal gel | Androgel / Testogel (AbbVie/Besins) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | |
| S088 | Ethinylestradiol / levonorgestrel | Tablet (IR, oral) | Microgynon (Bayer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S089 | Ethinylestradiol / drospirenone | Tablet (IR, oral) | Yasmin / Yaz (Bayer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S090 | Desogestrel | Tablet (IR, oral) | Cerazette (Organon) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S091 | Medroxyprogesterone acetate | Suspension for injection | Depo-Provera (Pfizer) | A | Physicochemical, structural & functional characterisation ± PK/clinical (complex product) | Depot suspension |
| S092 | Tamoxifen citrate | Tablet (IR, oral) | Nolvadex (AstraZeneca) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S093 | Anastrozole | Tablet (IR, oral) | Arimidex (AstraZeneca) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S094 | Letrozole | Tablet (IR, oral) | Femara (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S095 | Bicalutamide | Tablet (IR, oral) | Casodex (AstraZeneca) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S096 | Omeprazole | Gastro-resistant capsule (oral) | Losec / Prilosec (AstraZeneca) | A | In vivo bioequivalence (PK); gastro-resistant / enteric-coated | |
| S097 | Esomeprazole | Gastro-resistant tablet (oral) | Nexium (AstraZeneca) | A | In vivo bioequivalence (PK); gastro-resistant / enteric-coated | |
| S098 | Pantoprazole | Gastro-resistant tablet (oral) | Protonix / Controloc (Takeda/Pfizer) | A | In vivo bioequivalence (PK); gastro-resistant / enteric-coated | |
| S099 | Lansoprazole | Gastro-resistant capsule (oral) | Prevacid / Zoton (Takeda) | A | In vivo bioequivalence (PK); gastro-resistant / enteric-coated | |
| S100 | Rabeprazole sodium | Gastro-resistant tablet (oral) | Pariet / Aciphex (Eisai/Janssen) | A | In vivo bioequivalence (PK); gastro-resistant / enteric-coated | |
| S101 | Famotidine | Tablet (IR, oral) | Pepcid (Otsuka) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S102 | Domperidone | Tablet (IR, oral) | Motilium (Janssen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S103 | Metoclopramide | Tablet (IR, oral) | Innovator | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S104 | Ondansetron | Tablet (IR, oral) | Zofran (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S105 | Ondansetron | Solution for injection | Zofran (Novartis) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | |
| S106 | Mesalazine (mesalamine) | Gastro-resistant / MR tablet (oral) | Pentasa / Asacol (Ferring/Tillotts) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | Locally acting GI |
| S107 | Ursodeoxycholic acid | Capsule (oral) | Ursofalk (Dr Falk) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S108 | Loperamide hydrochloride | Capsule (oral) | Imodium (Janssen) | A | In vivo bioequivalence (PK), or BCS-based biowaiver where eligible — ICH M13A / ICH M9 | |
| S109 | Lactulose | Oral solution | Duphalac (Abbott) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | Solution — Q1/Q2 sameness |
| S110 | Hyoscine butylbromide | Tablet (IR, oral) | Buscopan (Sanofi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S111 | Sertraline | Tablet (IR, oral) | Zoloft / Lustral (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S112 | Escitalopram oxalate | Tablet (IR, oral) | Cipralex / Lexapro (Lundbeck) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S113 | Citalopram hydrobromide | Tablet (IR, oral) | Cipramil / Celexa (Lundbeck) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S114 | Fluoxetine hydrochloride | Capsule (oral) | Prozac (Lilly) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S115 | Paroxetine hydrochloride | Tablet (IR, oral) | Seroxat / Paxil (GSK) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S116 | Venlafaxine | Prolonged-release capsule (oral) | Effexor XR (Pfizer) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S117 | Duloxetine hydrochloride | Gastro-resistant capsule (oral) | Cymbalta (Lilly) | A | In vivo bioequivalence (PK); gastro-resistant / enteric-coated | |
| S118 | Mirtazapine | Tablet (IR, oral) | Remeron / Zispin (Organon) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S119 | Amitriptyline hydrochloride | Tablet (IR, oral) | Innovator | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S120 | Bupropion hydrochloride | Prolonged-release tablet (oral) | Wellbutrin / Zyban (GSK) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S121 | Alprazolam | Tablet (IR, oral) | Xanax (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Controlled substance |
| S122 | Diazepam | Tablet (IR, oral) | Valium (Roche) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Controlled substance |
| S123 | Lorazepam | Tablet (IR, oral) | Ativan (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Controlled substance |
| S124 | Zolpidem tartrate | Tablet (IR, oral) | Stilnox / Ambien (Sanofi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Controlled substance |
| S125 | Buspirone hydrochloride | Tablet (IR, oral) | Buspar (BMS) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S126 | Quetiapine | Prolonged-release tablet (oral) | Seroquel XR (AstraZeneca) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S127 | Olanzapine | Tablet (IR, oral) | Zyprexa (Lilly) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S128 | Risperidone | Tablet (IR, oral) | Risperdal (Janssen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S129 | Aripiprazole | Tablet (IR, oral) | Abilify (Otsuka) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S130 | Paliperidone | Prolonged-release tablet (oral) | Invega (Janssen) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S131 | Clozapine | Tablet (IR, oral) | Clozaril / Leponex (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Haematological monitoring |
| S132 | Lithium carbonate | Prolonged-release tablet (oral) | Priadel / Camcolit | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | Narrow therapeutic index |
| S133 | Lamotrigine | Tablet (IR, oral) | Lamictal (GSK) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S134 | Levetiracetam | Tablet (IR, oral) | Keppra (UCB) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S135 | Valproate sodium / valproic acid | Gastro-resistant / MR tablet (oral) | Depakine / Epilim (Sanofi) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | Narrow therapeutic index |
| S136 | Carbamazepine | Prolonged-release tablet (oral) | Tegretol (Novartis) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | Narrow therapeutic index |
| S137 | Oxcarbazepine | Tablet (IR, oral) | Trileptal (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S138 | Topiramate | Tablet (IR, oral) | Topamax (Janssen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S139 | Pregabalin | Capsule (oral) | Lyrica (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S140 | Gabapentin | Capsule (oral) | Neurontin (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S141 | Phenytoin sodium | Capsule (oral) | Epanutin / Dilantin (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Narrow therapeutic index |
| S142 | Levodopa / carbidopa | Tablet (IR, oral) | Sinemet (MSD) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S143 | Levodopa / carbidopa / entacapone | Tablet (IR, oral) | Stalevo (Orion/Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S144 | Pramipexole | Prolonged-release tablet (oral) | Mirapexin / Mirapex (Boehringer) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S145 | Ropinirole | Prolonged-release tablet (oral) | Requip XL (GSK) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S146 | Rivastigmine | Transdermal patch | Exelon (Novartis) | A | In vivo bioequivalence (PK) + adhesion and skin-tolerability studies | |
| S147 | Donepezil hydrochloride | Tablet (IR, oral) | Aricept (Eisai/Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S148 | Memantine hydrochloride | Tablet (IR, oral) | Ebixa / Namenda (Lundbeck) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S149 | Methylphenidate hydrochloride | Prolonged-release tablet (oral) | Concerta (Janssen) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | Controlled substance |
| S150 | Atomoxetine | Capsule (oral) | Strattera (Lilly) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S151 | Sumatriptan | Tablet (IR, oral) | Imigran / Imitrex (GSK) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S152 | Betahistine dihydrochloride | Tablet (IR, oral) | Betaserc (Abbott) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S153 | Paracetamol (acetaminophen) | Tablet (IR, oral) | Panadol (Haleon) | A | In vivo bioequivalence (PK), or BCS-based biowaiver where eligible — ICH M13A / ICH M9 | Biowaiver often applies |
| S154 | Ibuprofen | Tablet (IR, oral) | Brufen / Advil | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S155 | Diclofenac sodium | Gastro-resistant tablet (oral) | Voltaren (Novartis/GSK) | A | In vivo bioequivalence (PK); gastro-resistant / enteric-coated | |
| S156 | Diclofenac diethylamine | Gel (topical) | Voltaren Emulgel (Haleon) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | |
| S157 | Naproxen | Tablet (IR, oral) | Naprosyn (Atnahs) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S158 | Celecoxib | Capsule (oral) | Celebrex (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S159 | Etoricoxib | Tablet (IR, oral) | Arcoxia (MSD) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S160 | Meloxicam | Tablet (IR, oral) | Mobic (Boehringer Ingelheim) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S161 | Ketorolac trometamol | Solution for injection | Toradol (Atnahs) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | |
| S162 | Tramadol hydrochloride | Capsule (oral) | Tramal / Ultram (Grünenthal) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Controlled substance |
| S163 | Tramadol / paracetamol | Tablet (IR, oral) | Zaldiar / Ultracet (Grünenthal/Janssen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S164 | Morphine sulfate | Prolonged-release tablet (oral) | MST Continus (Napp) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | Controlled substance |
| S165 | Oxycodone hydrochloride | Prolonged-release tablet (oral) | OxyContin (Mundipharma) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | Controlled substance |
| S166 | Fentanyl | Transdermal patch | Durogesic / Duragesic (Janssen) | A | In vivo bioequivalence (PK) + adhesion and skin-tolerability studies | Controlled substance |
| S167 | Buprenorphine | Transdermal patch | BuTrans / Transtec (Napp/Grünenthal) | A | In vivo bioequivalence (PK) + adhesion and skin-tolerability studies | Controlled substance |
| S168 | Pregabalin | Prolonged-release tablet (oral) | Lyrica CR (Pfizer) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S169 | Allopurinol | Tablet (IR, oral) | Zyloric (Aspen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S170 | Febuxostat | Tablet (IR, oral) | Adenuric / Uloric (Menarini/Takeda) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S171 | Colchicine | Tablet (IR, oral) | Colcrys (Takeda) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Narrow therapeutic index |
| S172 | Amoxicillin | Capsule (oral) | Amoxil (GSK) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S173 | Amoxicillin | Powder for oral suspension | Amoxil (GSK) | A | In vivo bioequivalence (PK) — ICH M13A principles (oral liquid) | |
| S174 | Amoxicillin / clavulanic acid | Tablet (IR, oral) | Augmentin (GSK) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S175 | Ampicillin | Capsule (oral) | Innovator | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S176 | Flucloxacillin sodium | Capsule (oral) | Floxapen (Actavis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S177 | Cefuroxime axetil | Tablet (IR, oral) | Zinnat / Ceftin (GSK) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S178 | Cefixime | Capsule (oral) | Suprax (Sanofi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S179 | Cefdinir | Capsule (oral) | Omnicef (AbbVie) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S180 | Ceftriaxone sodium | Powder for solution for injection | Rocephin (Roche) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | |
| S181 | Cefotaxime sodium | Powder for solution for injection | Claforan (Sanofi) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | |
| S182 | Ceftazidime | Powder for solution for injection | Fortum (GSK) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | |
| S183 | Meropenem | Powder for solution for injection | Meronem / Merrem (Pfizer) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | |
| S184 | Piperacillin / tazobactam | Powder for solution for injection | Tazocin / Zosyn (Pfizer) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | |
| S185 | Azithromycin | Tablet (IR, oral) | Zithromax (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S186 | Clarithromycin | Tablet (IR, oral) | Klacid / Biaxin (Abbott) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S187 | Erythromycin | Gastro-resistant tablet (oral) | Innovator | A | In vivo bioequivalence (PK); gastro-resistant / enteric-coated | |
| S188 | Ciprofloxacin | Tablet (IR, oral) | Cipro / Ciproxin (Bayer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S189 | Levofloxacin | Tablet (IR, oral) | Tavanic / Levaquin (Sanofi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S190 | Moxifloxacin | Tablet (IR, oral) | Avelox (Bayer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S191 | Ofloxacin | Tablet (IR, oral) | Tarivid (Sanofi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S192 | Doxycycline | Capsule (oral) | Vibramycin (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S193 | Minocycline hydrochloride | Capsule (oral) | Minocin (Viatris) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S194 | Metronidazole | Tablet (IR, oral) | Flagyl (Sanofi) | A | In vivo bioequivalence (PK), or BCS-based biowaiver where eligible — ICH M13A / ICH M9 | BCS I biowaiver candidate |
| S195 | Clindamycin hydrochloride | Capsule (oral) | Dalacin C / Cleocin (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S196 | Trimethoprim / sulfamethoxazole | Tablet (IR, oral) | Bactrim / Septrin (Roche/Aspen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S197 | Nitrofurantoin | Capsule (oral) | Macrobid / Furadantin (Alvogen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S198 | Fosfomycin trometamol | Granules for oral solution | Monurol / Monuril (Zambon) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | Sachet — Q1/Q2 sameness |
| S199 | Vancomycin hydrochloride | Powder for solution for infusion | Vancocin (Aspen) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | |
| S200 | Linezolid | Tablet (IR, oral) | Zyvox / Zyvoxid (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S201 | Rifaximin | Tablet (IR, oral) | Xifaxan / Targaxan (Alfasigma) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Locally acting |
| S202 | Fluconazole | Capsule (oral) | Diflucan (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S203 | Itraconazole | Capsule (oral) | Sporanox (Janssen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S204 | Voriconazole | Tablet (IR, oral) | Vfend (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S205 | Terbinafine hydrochloride | Tablet (IR, oral) | Lamisil (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S206 | Nystatin | Oral suspension | Innovator | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | Suspension — sameness |
| S207 | Aciclovir | Tablet (IR, oral) | Zovirax (GSK) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S208 | Valaciclovir hydrochloride | Tablet (IR, oral) | Valtrex (GSK) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S209 | Oseltamivir phosphate | Capsule (oral) | Tamiflu (Roche) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S210 | Tenofovir disoproxil fumarate | Tablet (IR, oral) | Viread (Gilead) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S211 | Tenofovir alafenamide / emtricitabine | Tablet (IR, oral) | Descovy (Gilead) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S212 | Dolutegravir | Tablet (IR, oral) | Tivicay (ViiV Healthcare) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S213 | Efavirenz / emtricitabine / tenofovir | Tablet (IR, oral) | Atripla (Gilead/BMS) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S214 | Sofosbuvir / velpatasvir | Tablet (IR, oral) | Epclusa (Gilead) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S215 | Ledipasvir / sofosbuvir | Tablet (IR, oral) | Harvoni (Gilead) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S216 | Entecavir | Tablet (IR, oral) | Baraclude (BMS) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S217 | Hydroxychloroquine sulfate | Tablet (IR, oral) | Plaquenil (Sanofi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S218 | Artemether / lumefantrine | Tablet (IR, oral) | Coartem / Riamet (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S219 | Praziquantel | Tablet (IR, oral) | Biltricide (Bayer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S220 | Albendazole | Tablet (IR, oral) | Zentel (GSK) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S221 | Ivermectin | Tablet (IR, oral) | Stromectol (MSD) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S222 | Isoniazid | Tablet (IR, oral) | Innovator | A | In vivo bioequivalence (PK), or BCS-based biowaiver where eligible — ICH M13A / ICH M9 | |
| S223 | Rifampicin | Capsule (oral) | Rifadin / Rimactane (Sanofi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S224 | Rifampicin / isoniazid / pyrazinamide / ethambutol | Tablet (IR, oral) | Innovator (WHO PQ) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | WHO-prequalified FDC |
| S225 | Salbutamol (albuterol) | Pressurised metered-dose inhaler | Ventolin (GSK) | A | In vitro (aerodynamic particle-size distribution) + PK + PD/clinical — weight-of-evidence | Orally inhaled (complex) |
| S226 | Fluticasone propionate / salmeterol | Dry-powder inhaler | Seretide / Advair (GSK) | A | In vitro (aerodynamic particle-size distribution) + PK + PD/clinical — weight-of-evidence | Complex combination |
| S227 | Budesonide / formoterol | Dry-powder / MDI inhaler | Symbicort (AstraZeneca) | A | In vitro (aerodynamic particle-size distribution) + PK + PD/clinical — weight-of-evidence | Complex combination |
| S228 | Beclometasone dipropionate | Pressurised metered-dose inhaler | Qvar / Clenil (Teva/Chiesi) | A | In vitro (aerodynamic particle-size distribution) + PK + PD/clinical — weight-of-evidence | |
| S229 | Tiotropium bromide | Soft-mist / dry-powder inhaler | Spiriva (Boehringer Ingelheim) | A | In vitro (aerodynamic particle-size distribution) + PK + PD/clinical — weight-of-evidence | |
| S230 | Ipratropium bromide | Nebuliser solution | Atrovent (Boehringer Ingelheim) | A | In vitro (aerodynamic particle-size distribution) + PK + PD/clinical — weight-of-evidence | |
| S231 | Montelukast | Tablet (IR, oral) | Singulair (MSD) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S232 | Fluticasone furoate | Aqueous nasal spray | Avamys / Veramyst (GSK) | A | In vitro (aerodynamic particle-size distribution) + PK + PD/clinical — weight-of-evidence | Nasal product |
| S233 | Mometasone furoate | Aqueous nasal spray | Nasonex (Organon) | A | In vitro (aerodynamic particle-size distribution) + PK + PD/clinical — weight-of-evidence | Nasal product |
| S234 | Cetirizine hydrochloride | Tablet (IR, oral) | Zyrtec (UCB/J&J) | A | In vivo bioequivalence (PK), or BCS-based biowaiver where eligible — ICH M13A / ICH M9 | BCS I biowaiver candidate |
| S235 | Levocetirizine dihydrochloride | Tablet (IR, oral) | Xyzal (UCB) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S236 | Loratadine | Tablet (IR, oral) | Claritin / Clarityn (Bayer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S237 | Desloratadine | Tablet (IR, oral) | Aerius / Clarinex (Organon) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S238 | Fexofenadine hydrochloride | Tablet (IR, oral) | Telfast / Allegra (Sanofi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S239 | Bilastine | Tablet (IR, oral) | Bilaxten / Ilaxten (Faes Farma) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S240 | Acetylcysteine | Effervescent tablet (oral) | Fluimucil (Zambon) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | Effervescent — sameness |
| S241 | Roflumilast | Tablet (IR, oral) | Daxas / Daliresp (AstraZeneca) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S242 | Imatinib mesilate | Tablet/capsule (oral) | Glivec / Gleevec (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S243 | Erlotinib | Tablet (IR, oral) | Tarceva (Roche) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S244 | Gefitinib | Tablet (IR, oral) | Iressa (AstraZeneca) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S245 | Sunitinib | Capsule (oral) | Sutent (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S246 | Sorafenib | Tablet (IR, oral) | Nexavar (Bayer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S247 | Lapatinib | Tablet (IR, oral) | Tyverb / Tykerb (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S248 | Dasatinib | Tablet (IR, oral) | Sprycel (BMS) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S249 | Nilotinib | Capsule (oral) | Tasigna (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S250 | Pazopanib | Tablet (IR, oral) | Votrient (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S251 | Ibrutinib | Capsule/tablet (oral) | Imbruvica (Janssen/AbbVie) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S252 | Palbociclib | Capsule/tablet (oral) | Ibrance (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S253 | Olaparib | Tablet (IR, oral) | Lynparza (AstraZeneca) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S254 | Lenalidomide | Capsule (oral) | Revlimid (BMS) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Risk-management programme |
| S255 | Abiraterone acetate | Tablet (IR, oral) | Zytiga (Janssen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S256 | Enzalutamide | Capsule/tablet (oral) | Xtandi (Astellas/Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S257 | Capecitabine | Tablet (IR, oral) | Xeloda (Roche) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S258 | Methotrexate | Tablet (IR, oral) | Innovator | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Narrow therapeutic index |
| S259 | Temozolomide | Capsule (oral) | Temodal / Temodar (MSD) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S260 | Hydroxycarbamide (hydroxyurea) | Capsule (oral) | Hydrea (BMS) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S261 | Cisplatin | Concentrate for solution for infusion | Innovator | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | |
| S262 | Carboplatin | Concentrate for solution for infusion | Paraplatin (BMS) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | |
| S263 | Paclitaxel | Concentrate for solution for infusion | Taxol (BMS) | A | Physicochemical, structural & functional characterisation ± PK/clinical (complex product) | Complex/solvent-based |
| S264 | Docetaxel | Concentrate for solution for infusion | Taxotere (Sanofi) | A | Physicochemical, structural & functional characterisation ± PK/clinical (complex product) | Complex |
| S265 | Gemcitabine | Powder for solution for infusion | Gemzar (Lilly) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | |
| S266 | Doxorubicin hydrochloride (liposomal) | Dispersion for infusion | Caelyx / Doxil (Janssen) | A | Physicochemical, structural & functional characterisation ± PK/clinical (complex product) | Complex liposomal — Q3/critical attributes |
| S267 | Tacrolimus | Capsule (oral) | Prograf (Astellas) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Narrow therapeutic index |
| S268 | Tacrolimus | Prolonged-release capsule (oral) | Advagraf / Astagraf XL (Astellas) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | Narrow therapeutic index |
| S269 | Ciclosporin | Capsule (oral, microemulsion) | Neoral / Sandimmun (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Narrow therapeutic index; microemulsion |
| S270 | Mycophenolate mofetil | Capsule/tablet (oral) | CellCept (Roche) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S271 | Sirolimus | Tablet (IR, oral) | Rapamune (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Narrow therapeutic index |
| S272 | Everolimus | Tablet (IR, oral) | Certican / Afinitor (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S273 | Azathioprine | Tablet (IR, oral) | Imuran / Azasan (Aspen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S274 | Leflunomide | Tablet (IR, oral) | Arava (Sanofi) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S275 | Apremilast | Tablet (IR, oral) | Otezla (Amgen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S276 | Tofacitinib | Tablet (IR, oral) | Xeljanz (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S277 | Baricitinib | Tablet (IR, oral) | Olumiant (Lilly) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S278 | Latanoprost | Eye drops, solution | Xalatan (Pfizer) | A | Q1/Q2/Q3 sameness ± clinical endpoint — product-specific | Q1/Q2/Q3 sameness |
| S279 | Bimatoprost | Eye drops, solution | Lumigan (AbbVie/Allergan) | A | Q1/Q2/Q3 sameness ± clinical endpoint — product-specific | |
| S280 | Travoprost | Eye drops, solution | Travatan (Novartis/Alcon) | A | Q1/Q2/Q3 sameness ± clinical endpoint — product-specific | |
| S281 | Timolol maleate | Eye drops, solution | Timoptic (Santen/MSD) | A | Q1/Q2/Q3 sameness ± clinical endpoint — product-specific | |
| S282 | Dorzolamide / timolol | Eye drops, solution | Cosopt (Santen/MSD) | A | Q1/Q2/Q3 sameness ± clinical endpoint — product-specific | |
| S283 | Brimonidine tartrate | Eye drops, solution | Alphagan (AbbVie/Allergan) | A | Q1/Q2/Q3 sameness ± clinical endpoint — product-specific | |
| S284 | Moxifloxacin | Eye drops, solution | Vigamox (Alcon/Novartis) | A | Q1/Q2/Q3 sameness ± clinical endpoint — product-specific | |
| S285 | Olopatadine hydrochloride | Eye drops, solution | Patanol / Pataday (Alcon/Novartis) | A | Q1/Q2/Q3 sameness ± clinical endpoint — product-specific | |
| S286 | Ciclosporin | Eye drops, emulsion | Restasis / Ikervis (AbbVie/Santen) | A | Q1/Q2/Q3 sameness ± clinical endpoint — product-specific | Ophthalmic emulsion — complex |
| S287 | Betamethasone valerate | Cream (topical) | Betnovate (GSK) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | IVRT / vasoconstrictor |
| S288 | Betamethasone dipropionate / calcipotriol | Gel/ointment (topical) | Daivobet / Taclonex (LEO Pharma) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | |
| S289 | Clobetasol propionate | Cream/ointment (topical) | Dermovate / Temovate (GSK) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | |
| S290 | Hydrocortisone | Cream (topical) | Innovator | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | |
| S291 | Mometasone furoate | Cream (topical) | Elocon (Organon) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | |
| S292 | Tacrolimus | Ointment (topical) | Protopic (LEO Pharma) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | Topical calcineurin inhibitor |
| S293 | Clotrimazole | Cream (topical) | Canesten (Bayer) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | |
| S294 | Ketoconazole | Cream / shampoo (topical) | Nizoral (Janssen) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | |
| S295 | Terbinafine hydrochloride | Cream (topical) | Lamisil (GSK/Novartis) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | |
| S296 | Adapalene | Gel (topical) | Differin (Galderma) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | Clinical endpoint |
| S297 | Adapalene / benzoyl peroxide | Gel (topical) | Epiduo (Galderma) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | |
| S298 | Tretinoin | Cream/gel (topical) | Retin-A (Janssen/Bausch) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | |
| S299 | Metronidazole | Gel (topical) | Rozex / MetroGel (Galderma) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | |
| S300 | Diclofenac sodium | Gel (topical) | Solaraze / Voltaren (Almirall/Haleon) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | |
| S301 | Lidocaine | Medicated plaster (topical) | Versatis / Lidoderm (Grünenthal) | A | In vitro release/permeation (IVRT/IVPT) and/or PD or clinical endpoint — product-specific | |
| S302 | Tamsulosin hydrochloride | Prolonged-release capsule (oral) | Flomax / Omnic (Boehringer/Astellas) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S303 | Alfuzosin hydrochloride | Prolonged-release tablet (oral) | Xatral / Uroxatral (Sanofi) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S304 | Silodosin | Capsule (oral) | Urorec / Rapaflo (Recordati/Allergan) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S305 | Dutasteride | Capsule (oral) | Avodart (GSK) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S306 | Finasteride | Tablet (IR, oral) | Proscar / Propecia (MSD) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S307 | Tadalafil | Tablet (IR, oral) | Cialis (Lilly) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S308 | Sildenafil citrate | Tablet (IR, oral) | Viagra (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S309 | Vardenafil | Tablet (IR, oral) | Levitra (Bayer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S310 | Solifenacin succinate | Tablet (IR, oral) | Vesicare (Astellas) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S311 | Mirabegron | Prolonged-release tablet (oral) | Betmiga / Myrbetriq (Astellas) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S312 | Oxybutynin | Prolonged-release tablet (oral) | Ditropan XL (Janssen) | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S313 | Bosentan | Tablet (IR, oral) | Tracleer (Janssen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S314 | Macitentan | Tablet (IR, oral) | Opsumit (Janssen) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S315 | Sildenafil citrate | Tablet (IR, oral) | Revatio (Pfizer) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S316 | Riociguat | Tablet (IR, oral) | Adempas (Bayer/MSD) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S317 | Colecalciferol (vitamin D3) | Capsule / oral drops | Innovator | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | |
| S318 | Ferrous sulfate | Prolonged-release tablet (oral) | Innovator | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S319 | Ferric carboxymaltose | Solution for injection/infusion | Ferinject / Injectafer (Vifor) | A | Physicochemical, structural & functional characterisation ± PK/clinical (complex product) | Complex iron — Q3/critical attributes |
| S320 | Cyanocobalamin (vitamin B12) | Solution for injection | Innovator | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | |
| S321 | Folic acid | Tablet (IR, oral) | Innovator | A | In vivo bioequivalence (PK), or BCS-based biowaiver where eligible — ICH M13A / ICH M9 | |
| S322 | Potassium chloride | Prolonged-release tablet (oral) | Slow-K / Sando-K | A | In vivo bioequivalence (PK; fasting + fed; multiple-dose where required) | |
| S323 | Ondansetron | Orodispersible tablet (oral) | Zofran Zydis (Novartis) | A | In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A | Orodispersible |
| S324 | Sumatriptan | Solution for injection (autoinjector) | Imigran / Imitrex (GSK) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | |
| S325 | Glucagon | Powder + solvent for injection | GlucaGen (Novo Nordisk) | A | Q1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted | Peptide |
| S326 | Naloxone hydrochloride | Nasal spray | Nyxoid / Narcan (Mundipharma/Emergent) | A | In vitro (aerodynamic particle-size distribution) + PK + PD/clinical — weight-of-evidence | Nasal |
| S327 | Adalimumab | Solution for injection (pen/syringe) | Humira (AbbVie) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S328 | Etanercept | Solution for injection (fusion protein) | Enbrel (Amgen/Pfizer) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S329 | Infliximab | Powder for concentrate for infusion | Remicade (Janssen/MSD) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S330 | Rituximab | Concentrate for infusion | MabThera / Rituxan (Roche) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S331 | Trastuzumab | Powder for infusion | Herceptin (Roche) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S332 | Bevacizumab | Concentrate for infusion | Avastin (Roche) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S333 | Cetuximab | Solution for infusion | Erbitux (Merck KGaA) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S334 | Pertuzumab | Concentrate for infusion | Perjeta (Roche) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S335 | Filgrastim (G-CSF) | Solution for injection | Neupogen (Amgen) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S336 | Pegfilgrastim | Solution for injection | Neulasta (Amgen) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S337 | Epoetin alfa | Solution for injection | Eprex / Erypo (Janssen) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S338 | Darbepoetin alfa | Solution for injection | Aranesp (Amgen) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S339 | Insulin glargine | Solution for injection | Lantus (Sanofi) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S340 | Insulin lispro | Solution for injection | Humalog (Eli Lilly) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S341 | Insulin aspart | Solution for injection | NovoRapid / NovoLog (Novo Nordisk) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S342 | Ranibizumab | Solution for intravitreal injection | Lucentis (Novartis/Roche) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S343 | Aflibercept | Solution for intravitreal injection | Eylea (Bayer/Regeneron) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S344 | Denosumab | Solution for injection | Prolia / Xgeva (Amgen) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S345 | Tocilizumab | Solution for infusion / injection | RoActemra / Actemra (Roche) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S346 | Omalizumab | Solution for injection | Xolair (Novartis/Genentech) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S347 | Ustekinumab | Solution for injection | Stelara (Janssen) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S348 | Natalizumab | Concentrate for infusion | Tysabri (Biogen) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S349 | Somatropin (rhGH) | Solution / powder for injection | Genotropin / Norditropin (Pfizer/Novo Nordisk) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S350 | Teriparatide | Solution for injection (peptide) | Forteo / Forsteo (Eli Lilly) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S351 | Follitropin alfa | Solution for injection | Gonal-f (Merck KGaA) | A | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 | Biological — comparability exercise |
| S352 | Ranitidine hydrochloride | Tablet (IR, oral) | Zantac (Sanofi/GSK) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn ~2019-20 — nitrosamine (NDMA) contamination |
| S353 | Rofecoxib | Tablet (IR, oral) | Vioxx (Merck) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn 2004 — cardiovascular (myocardial infarction / stroke) risk |
| S354 | Valdecoxib | Tablet (IR, oral) | Bextra (Pfizer) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn 2005 — cardiovascular risk + serious skin reactions (SJS/TEN) |
| S355 | Cerivastatin | Tablet (IR, oral) | Baycol / Lipobay (Bayer) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn 2001 — rhabdomyolysis (esp. with gemfibrozil) |
| S356 | Troglitazone | Tablet (IR, oral) | Rezulin (Parke-Davis / Warner-Lambert) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn 2000 — severe hepatotoxicity |
| S357 | Rosiglitazone | Tablet (IR, oral) | Avandia (GSK) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Suspended in EU 2010; US use restricted — cardiovascular (ischaemic) risk |
| S358 | Cisapride | Tablet (IR, oral) | Prepulsid / Propulsid (Janssen) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn / severely restricted ~2000 — QT prolongation, fatal arrhythmias |
| S359 | Sibutramine | Capsule (oral) | Reductil / Meridia (Abbott) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn 2010 — cardiovascular events (SCOUT trial) |
| S360 | Rimonabant | Tablet (IR, oral) | Acomplia (Sanofi) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn 2008-09 (EU) — serious psychiatric effects (depression / suicidality) |
| S361 | Benfluorex | Tablet (IR, oral) | Mediator (Servier) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Suspended 2009, EU withdrawn 2010 — valvular heart disease / pulmonary hypertension |
| S362 | Terfenadine | Tablet (IR, oral) | Seldane / Triludan (Hoechst) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn late 1990s — QT prolongation / torsades (drug interactions) |
| S363 | Astemizole | Tablet (IR, oral) | Hismanal (Janssen) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn ~1999 — QT prolongation / cardiac arrhythmia |
| S364 | Grepafloxacin | Tablet (IR, oral) | Raxar (GSK) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn 1999 — QT prolongation / cardiac events |
| S365 | Trovafloxacin | Tablet (IR, oral) | Trovan (Pfizer) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn / severely restricted 1999 — severe hepatotoxicity |
| S366 | Lumiracoxib | Tablet (IR, oral) | Prexige (Novartis) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn ~2007-08 — severe hepatotoxicity |
| S367 | Nefazodone | Tablet (IR, oral) | Serzone (BMS) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn ~2003-04 (many markets) — hepatotoxicity |
| S368 | Ximelagatran | Tablet (IR, oral) | Exanta (AstraZeneca) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn 2006 — hepatotoxicity |
| S369 | Pergolide | Tablet (IR, oral) | Permax (Eli Lilly) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn 2007 (US) — cardiac valvulopathy |
| S370 | Tegaserod | Tablet (IR, oral) | Zelnorm / Zelmac (Novartis) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn 2007 — cardiovascular ischaemic events (later limited US reintroduction) |
| S371 | Aprotinin | Solution for injection | Trasylol (Bayer) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Suspended 2007-08 — mortality / renal risk (later restricted EU reintroduction) |
| S372 | Mibefradil | Tablet (IR, oral) | Posicor (Roche) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn 1998 — serious drug interactions / arrhythmia |
| S373 | Dextropropoxyphene | Tablet (IR, oral) | Distalgesic / Darvon (co-proxamol) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn ~2007-2011 — cardiotoxicity / overdose fatality |
| S374 | Bromfenac (oral) | Capsule (oral) | Duract (Wyeth) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn 1998 — severe hepatotoxicity |
| S375 | Efalizumab | Solution for injection | Raptiva (Genentech / Merck Serono) | D | Not applicable — do NOT use as comparator (originator withdrawn for safety) | Withdrawn 2009 — progressive multifocal leukoencephalopathy (PML) |
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Cite as: AUPAM Experts' Office, Reference-Product Register — 375 BE comparators, retrieved 2026-08-31, https://aupameo.org/datasets/reference-product-register.html
@misc{aupam_reference_product_register_2026,
author = {{AUPAM Experts' Office}},
title = {Reference-Product Register — 375 BE comparators},
year = {2026},
organization = {Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances},
howpublished = {\url{https://aupameo.org/datasets/reference-product-register.html}},
note = {Retrieved 2026-08-31}
}
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