Givlaari Alnylam Netherlands B.V. · Authorised · authorised 2 Mar 2020 · ATC A16AX16
Therapeutic indication (EMA)
Treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.
Active substance
Givosiran
- US FDA 1
- EMA 1
- Health Canada 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| GIVLAARI | EQ 189MG BASE/ML (EQ 189MG BASE/ML) | solution · subcutaneous | ALNYLAM PHARMS INC | Prescription | 20 Nov 2019 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| GIVLAARI | 02506343 | 189 MG / ML | SOLUTION · SUBCUTANEOUS | ALNYLAM NETHERLANDS B.V. |
Safety signals and safety-related labeling changes
- US FDA 29 Apr 2024 GIVLAARI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
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.