SABRIL

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Estonia, France, Hong Kong SAR China, Ireland, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Singapore, South Africa, Tunisia, Turkey, UK.

Active ingredients

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

1
UNII GR120KRT6K - VIGABATRIN
 

Vigabatrin is a selective irreversible inhibitor of GABA transaminase, the enzyme responsible for the breakdown of GABA (gamma aminobutyric acid). Vigabatrin increases the concentration of GABA, the major inhibitory neurotransmitter in the brain.

 
Read more about Vigabatrin

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 SABRIL Film-coated tablet MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

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

ATC Group Classification
N03AG04 Vigabatrin N Nervous system → N03 Antiepileptics → N03A Antiepileptics → N03AG Fatty acid derivatives
Discover more medicines within N03AG04

Authorization and marketing

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

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 2667J, 2668K
BR Câmara de Regulação do Mercado de Medicamentos 576720070081817
CA Health Products and Food Branch 02065819, 02068036
EE Ravimiamet 1116694
FR Base de données publique des médicaments 61139833, 67326875
GB Medicines & Healthcare Products Regulatory Agency 21523, 37117
HK Department of Health Drug Office 35365
IE Health Products Regulatory Authority 44726, 44768, 44970
JP 医薬品医療機器総合機構 1139013B1026
LT Valstybinė vaistų kontrolės tarnyba 1080060, 1080061, 1082649
MT Medicines Authority MA1359/03101
MX Comisión Federal para la Protección contra Riesgos Sanitarios 460M93
NL Z-Index G-Standaard, PRK 31771, 66141
NZ Medicines and Medical Devices Safety Authority 5938
PL Rejestru Produktów Leczniczych 100059220, 100097344
SG Health Sciences Authority 07955P
TN Direction de la Pharmacie et du Médicament 5933052H
TR İlaç ve Tıbbi Cihaz Kurumu 8699809090187, 8699809240513
US FDA, National Drug Code 67386-111, 67386-211
ZA Health Products Regulatory Authority 28/2.5/0021

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