This brand name is authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Turkey, UK.
The drug GIOTRIF contains one active pharmaceutical ingredient (API):
1
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UNII
V1T5K7RZ0B - AFATINIB DIMALEATE
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Afatinib is a potent and selective, irreversible ErbB Family Blocker. Afatinib covalently binds to and irreversibly blocks signalling from all homo- and heterodimers formed by the ErbB family members EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| GIOTRIF Film-coated tablet | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| L01EB03 | Afatinib | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EB Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 11329G, 11335N, 11336P, 11341X, 11342Y, 11347F, 11348G, 11359W |
| BR | Câmara de Regulação do Mercado de Medicamentos | 504516050020502, 504516050020602 |
| CA | Health Products and Food Branch | 02415666, 02415674, 02415682 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 318-MEE-0514, 320-MEE-0514, 342-MEE-0614, 343-MEE-0614 |
| EE | Ravimiamet | 1628029, 1628030, 1628041, 1628052, 1628063, 1628074, 1628085, 1628096, 1628108, 1628119, 1628120, 1628131 |
| ES | Centro de información online de medicamentos de la AEMPS | 113879003, 113879006, 113879009 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 073682, 122471, 174935, 571285 |
| FR | Base de données publique des médicaments | 60673325, 65580825, 67737086, 67904083 |
| GB | Medicines & Healthcare Products Regulatory Agency | 238563, 238590, 238594, 238615 |
| HK | Department of Health Drug Office | 63506, 63507, 63508 |
| IE | Health Products Regulatory Authority | 88011, 88028, 88037, 88108 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 7390, 7391, 7392, 7393 |
| JP | 医薬品医療機器総合機構 | 4291030F1020, 4291030F2027, 4291030F3023, 4291030F4020 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1071518, 1071519, 1071520, 1071521, 1071522, 1071523, 1071524, 1071525, 1071526, 1071527, 1071528, 1071529 |
| NL | Z-Index G-Standaard, PRK | 107603, 107611, 107638, 107646 |
| NZ | Medicines and Medical Devices Safety Authority | 16289, 16290, 16291, 16292 |
| PL | Rejestru Produktów Leczniczych | 100303157, 100303163, 100303170, 100303186 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W60260003, W60261003, W60262003, W60263003 |
| SG | Health Sciences Authority | 14460P, 14461P, 14462P, 14463P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699693090058, 8699693090065, 8699693090072 |
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