Active substance
Nilotinib d
- US FDA 1
- UK MHRA 3
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| NILOTINIB D-TARTRATE | EQ 50MG BASE; EQ 150MG BASE; EQ 200MG BASE | capsule · oral | CIPLA | Discontinued | 19 Feb 2025 |
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| NILOTINIB 150 MG HARD CAPSULES | PL 36390/0428 | CIPLA (EU) LIMITED | POM |
| NILOTINIB 200 MG HARD CAPSULES | PL 36390/0429 | CIPLA (EU) LIMITED | POM |
| NILOTINIB 50 MG HARD CAPSULES | PL 36390/0426 | CIPLA (EU) LIMITED | POM |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.