GIOTRIF

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom

Active ingredients

The drug GIOTRIF contains one active pharmaceutical ingredient (API):

1 Afatinib
UNII V1T5K7RZ0B - AFATINIB DIMALEATE

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.

Read about Afatinib

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
GIOTRIF Film-coated tablets European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
L01EB03 Afatinib L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EB Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
Discover more medicines within L01EB03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 11329G, 11335N, 11336P, 11341X, 11342Y, 11347F, 11348G, 11359W
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 504516050020502, 504516050020602
Country: CA Health Products and Food Branch Identifier(s): 02415666, 02415674, 02415682
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 318-MEE-0514, 320-MEE-0514, 342-MEE-0614, 343-MEE-0614
Country: EE Ravimiamet Identifier(s): 1628029, 1628030, 1628041, 1628052, 1628063, 1628074, 1628085, 1628096, 1628108, 1628119, 1628120, 1628131
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 113879003, 113879006, 113879009
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 073682, 122471, 174935, 571285
Country: FR Base de données publique des médicaments Identifier(s): 60673325, 65580825, 67737086, 67904083
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 238563, 238590, 238594, 238615
Country: HK Department of Health Drug Office Identifier(s): 63506, 63507, 63508
Country: IE Health Products Regulatory Authority Identifier(s): 88011, 88028, 88037, 88108
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 7390, 7391, 7392, 7393
Country: JP 医薬品医療機器総合機構 Identifier(s): 4291030F1020, 4291030F2027, 4291030F3023, 4291030F4020
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1071518, 1071519, 1071520, 1071521, 1071522, 1071523, 1071524, 1071525, 1071526, 1071527, 1071528, 1071529
Country: NL Z-Index G-Standaard, PRK Identifier(s): 107603, 107611, 107638, 107646
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 16289, 16290, 16291, 16292
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100303157, 100303163, 100303170, 100303186
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W60260003, W60261003, W60262003, W60263003
Country: SG Health Sciences Authority Identifier(s): 14460P, 14461P, 14462P, 14463P
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699693090058, 8699693090065, 8699693090072

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