Galcanezumab
Calcitonin Gene-Related Peptide (Cgrp) Antagonists
Sold as EMGALITY
- Drug class
- Calcitonin Gene-Related Peptide (Cgrp) Antagonists
- Availability
- See label
- Routes
- Subcutaneous
- Markets covered
- 3
- Products on record
- 10
Overview
Galcanezumab is an active pharmaceutical ingredient in the Calcitonin Gene-Related Peptide (Cgrp) Antagonists group (N02CD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 6 | May 29, 2026 |
| CA Canada | Health Canada | 3 | March 22, 2025 |
| EU European Union | EMA | 1 | January 27, 2026 |
GBUnited Kingdom· MHRA
6 products
Uses
Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
How to take
CACanada· Health Canada
3 products
Uses
EMGALITY® (galcanezumab) is indicated for: • the prevention of migraine in adults who have at least 4 migraine days per month. • the reduction in the frequency of attacks throughout a cluster period in adults with episodic cluster headache with prior cluster headache periods lasting at least 6 weeks and who have had an inadequate response to, or tolerated poorly, or had contraindications to conventional preventive therapies established by Canadian practice guidelines.
For patients with episodic cluster headache, the treatment benefit should be assessed within 3 weeks after initiation of the treatment. In patients with no improvement within this time period, continuation of the treatment should be carefully considered based on individual patient basis and clinical judgement (see PART I: DOSAGE AND ADMINISTRATION and PART II: CLINICAL TRIALS).
EMGALITY should be initiated by physicians experienced in the diagnosis and treatment of migraine or episodic cluster headache. 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
EUEuropean Union· EMA
1 product
Uses
Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
How to take
Sources & citations
- [1]MHRA (UK) · PLGB148950242 · revised May 29, 2026
- [2]Health Canada (DPD) · 02491060 · revised March 22, 2025
- [3]European Medicines Agency · EMEA/H/C/004648 · revised January 27, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.