GABITRIL

10 Milligram Film Coated Tablet

Teva Pharma B.V.PA0749/199/002

SPC: Preclinical safety data

01 Jul 2016 - 14 Oct 201614 Oct 2016 - Present

A long term carcinogenicity study in rats revealed a slightly increased incidence of hepatocellular adenomas in females in the high dose (200 mg/kg). The drug is non-genotoxic. The clinical relevance of these abnormalities is unknown.

A long term carcinogenicity study in rats revealed a slightly increased incidence of hepatocellular adenomas in females in the high dose (200 mg/kg). The drug is non-genotoxic. The clinical relevance of these abnormalities is unknown.

« Back

Latest Changes to Medicine Info & SPC


Please note changes to the medicine information and summary of product characteristics are only available from the 19/05/2015 onwards. Changes made before this date aren't available online.