KIGABEQ Soluble tablet Ref.[9297] Active ingredients: Vigabatrin

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: ORPHELIA Pharma SAS, 85 boulevard Saint-Michel, 75005, PARIS, France

Product name and form

Kigabeq 100 mg soluble tablets.

Kigabeq 500 mg soluble tablets.

Pharmaceutical Form

Soluble tablet.

White oval tablets. The tablets are scored on one side and can be divided into equal doses.

500 mg tablet size: 16.0 mm x 9.0 mm

100 mg tablet size: 9.4 mm x 5.3 mm

Qualitative and quantitative composition

Kigabeq 100 mg soluble tablets: Each soluble tablet contains 100 mg vigabatrin.

Kigabeq 500 mg soluble tablets: Each soluble tablet contains 500 mg vigabatrin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
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.
List of Excipients

Crospovidone type B
Mannitol
Sodium stearyl fumarate

Pack sizes and marketing

Kigabeq 100 mg soluble tablets:

HDPE bottle closed with a child resistant tamper evident PP screw cap.

Pack size: 100 soluble tablets.

Kigabeq 500 mg soluble tablets:

HDPE bottle closed with a child resistant tamper evident PP screw cap.

Pack size: 50 soluble tablets.

Marketing authorization holder

ORPHELIA Pharma SAS, 85 boulevard Saint-Michel, 75005, PARIS, France

Marketing authorization dates and numbers

Kigabeq 100 mg soluble tablets: EU/1/18/1302/001
Kigabeq 500 mg soluble tablets: EU/1/18/1302/002

Date of first authorisation: 20 September 2018

Drugs

Drug Countries
KIGABEQ Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom
 
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