Emgality Eli Lilly Nederland B.V. · Authorised · authorised 14 Nov 2018 · ATC N02
Therapeutic indication (EMA)
Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
Active substance
Galcanezumab
- SFDA 2
- US FDA 1
- EMA 1
- Health Canada 3
- US price lines 3
- NHS prices 1
- Safety 8
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Emgality | 120 mg/ml | Solution for injection · Subcutaneous use | 1 Pre-filled syringe | SAR 1343.05 | Biological · Prescription | Eli Lilly and Company | Valid |
| Emgality | 100 mg/ml | Solution for injection · Subcutaneous use | 3 Pre-filled syringe | SAR 3357.65 | Biological · Prescription | Eli Lilly and Company | Valid |
Indications — CHI Daman Drug Formulary
MIGRAINE/ HEADACHE
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| EMGALITY | 120MG/ML | injectable · injection | ELI LILLY AND CO | Prescription | 27 Sep 2018 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | EMGALITY 120 MG/ML PEN | $734.28328 | per ML | 23 Sep 2026 |
| US NADAC | EMGALITY 120 MG/ML SYRINGE | $734.42083 | per ML | 23 Sep 2026 |
| US NADAC | EMGALITY 300 MG DOSE (100 MG/ML X 3 SYRINGES) | $612.51644 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Galcanezumab 120mg/1ml solution for injection pre-filled disposable devices | £450.00 | 1 pre-filled disposable injection | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- EMA PRAC 9 Jul 2026 PRAC signal: Raynaud’s phenomenon
Action for MAH: update of the product information: No - US FDA 5 Jun 2026 EMGALITY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 31 Oct 2024 PRAC signal: Insomnia
Action for MAH: update of the product information: No - EMA PRAC 3 Oct 2024 PRAC signal: Erectile dysfunction
Action for MAH: update of the product information: No - EMA PRAC 16 May 2024 PRAC signal: Insomnia
Action for MAH: update of the product information: No - EMA PRAC 11 Apr 2024 PRAC signal: Erectile dysfunction
Action for MAH: update of the product information: No - EMA PRAC 5 May 2022 PRAC signal: Raynaud’s phenomenon
Action for MAH: update of the product information: No - EMA PRAC 13 Jan 2022 PRAC signal: Raynaud’s phenomenon
Action for MAH: update of the product information: No
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), 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.