TROBALT Film-coated tablet Ref.[27968] Active ingredients: Retigabine

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Glaxo Group Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Product name and form

Trobalt 50 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Purple, round, film-coated tablets of 5.6 mm, marked with “RTG 50” on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 50 mg of retigabine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Retigabine

In vitro studies indicate that retigabine acts primarily through opening neuronal potassium channels. This stabilises the resting membrane potential and controls the sub-threshold electrical excitability in neurons, thus preventing the initiation of epileptiform action potential bursts. The mechanism of action of retigabine on potassium channels has been well documented, however other mechanisms by which retigabine may assert an antiepileptic effect have yet to be fully elucidated.

List of Excipients

Tablet core:

Croscarmellose sodium
Hypromellose
Magnesium stearate
Microcrystalline cellulose

Film-coating:

50 mg tablets:

Polyvinyl alcohol
Titanium dioxide (E171)
Talc (E553b)
Indigo carmine aluminium lake (E132)
Carmine (E120)
Lecithin (SOY)
Xanthan gum

Pack sizes and marketing

50 mg tablets:

Opaque PVC-PVDC-aluminium foil blisters. Packs containing 21or 84 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Glaxo Group Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Marketing authorization dates and numbers

EU/1/11/681/001, EU/1/11/681/002

Date of first authorisation: 28 March 2011
Date of latest renewal: 14 January 2016

Drugs

Drug Countries
TROBALT Estonia, Lithuania

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