GIVLAARI

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

Active ingredients

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

1
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 more about Givosiran

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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

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