Givosiran
Various Alimentary Tract and Metabolism Products
Sold as Givlaari
- Drug class
- Various Alimentary Tract and Metabolism Products
- Availability
- See label
- Routes
- Subcutaneous
- Markets covered
- 3
- Products on record
- 3
Overview
Givosiran is an active pharmaceutical ingredient in the Various Alimentary Tract and Metabolism Products group (A16AX). 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 | 1 | May 15, 2026 |
| EU European Union | EMA | 1 | May 8, 2025 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
GBUnited Kingdom· MHRA
1 product
Uses
Givlaari is indicated for the treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.
How to take
EUEuropean Union· EMA
1 product
Uses
Givlaari is indicated for the treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.
How to take
CACanada· Health Canada
1 product
Uses
GIVLAARI (givosiran) is indicated for the treatment of acute hepatic porphyria (AHP) in adults. 1 Pediatrics Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of GIVLAARI in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use (see 7 WARNINGS AND PRECAUTIONS, Special Populations, 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
2 Geriatrics Geriatrics (≥65 years of age): Clinical studies of GIVLAARI did not include sufficient numbers of patients to determine if the use in geriatric patients is associated with differences in safety or effectiveness (see 7 WARNINGS AND PRECAUTIONS, Special Populations, 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
Drug interactions
Known interactions involving Givosiran. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB505970004 · revised May 15, 2026
- [2]European Medicines Agency · EMEA/H/C/004775 · revised May 8, 2025
- [3]Health Canada (DPD) · 02506343 · revised March 22, 2025
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.