This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, New Zealand, Poland, Romania, South Africa, Spain, Turkey, UK.
The drug EMGALITY contains one active pharmaceutical ingredient (API):
1
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UNII
55KHL3P693 - GALCANEZUMAB
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Galcanezumab is a humanised IgG4 monoclonal antibody that binds calcitonin gene-related peptide (CGRP) thus preventing its biological activity. Elevated blood concentrations of CGRP have been associated with migraine attacks. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| EMGALITY Solution for injection | 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 | |
|---|---|---|
| N02CD02 | N Nervous system → N02 Analgesics → N02C Antimigraine preparations → N02CD Calcitonin gene-related peptide (CGRP) antagonists | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 12469G, 12478R |
| BR | Câmara de Regulação do Mercado de Medicamentos | 507620030020707, 507620040020807, 507620040020907, 507620040021007, 507620040021107, 507620040021207, 507620040021307 |
| CA | Health Products and Food Branch | 02491060, 02491087, 02505134 |
| EE | Ravimiamet | 1782918, 1782929, 1808513, 1819065, 1819076, 1819087 |
| ES | Centro de información online de medicamentos de la AEMPS | 1181330001 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 468840 |
| FR | Base de données publique des médicaments | 69972332 |
| GB | Medicines & Healthcare Products Regulatory Agency | 374998 |
| HK | Department of Health Drug Office | 66579, 66580 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 8741 |
| JP | 医薬品医療機器総合機構 | 1190404G1020, 1190404G2026 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1086592, 1086593, 1086594, 1086595, 1087097, 1087098 |
| NZ | Medicines and Medical Devices Safety Authority | 20981, 20982 |
| PL | Rejestru Produktów Leczniczych | 100413118 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W67371001, W67371002, W67371005 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699673954714, 8699673954721, 8699673954738, 8699673954851 |
| US | FDA, National Drug Code | 0002-1436, 0002-2377, 0002-3115 |
| ZA | Health Products Regulatory Authority | 54/30.1/0062 |
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