GIVLAARI

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United States

Active ingredients

The drug GIVLAARI contains one active pharmaceutical ingredient (API):

1 Givosiran UNII 5XE21E41RT - GIVOSIRAN SODIUM

Givosiran is a double-stranded small interfering ribonucleic acid (siRNA) that causes degradation of aminolevulinic acid synthase 1 (ALAS1) messenger ribonucleic acid (mRNA) in hepatocytes through RNA interference, resulting in a reduction of induced liver ALAS1 mRNA towards normal. This leads to reduced circulating levels of neurotoxic intermediates aminolevulinic acid (ALA) and porphobilinogen (PBG), the key causal factors of attacks and other disease manifestations of AHP. Read about Givosiran

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
GIVLAARI Solution for injection	FDA, National Drug Code (US)	MPI, US: SPL/PLR
GIVLAARI Solution for injection	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
A16AX16		A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AX Various alimentary tract and metabolism products
Discover more medicines within A16AX16

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 587920100000207
Country: CA	Health Products and Food Branch	Identifier(s): 02506343
Country: EE	Ravimiamet	Identifier(s): 1814138
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1201428001
Country: FR	Base de données publique des médicaments	Identifier(s): 68318874
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8769
Country: IT	Agenzia del Farmaco	Identifier(s): 048516013
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999461A1023
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1089519
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100433397
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W66769001
Country: US	FDA, National Drug Code	Identifier(s): 71336-1001