COMTAN Film-coated tablet Ref.[7515] Active ingredients: Entacapone

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

Comtan 200 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Brownish-orange, oval, biconvex film-coated tablet with “Comtan” engraved on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 200 mg entacapone.

Excipient with known effect: Each tablet contains 1.82 mg sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Entacapone

Entacapone belongs to a new therapeutic class, catechol-O-methyl transferase (COMT) inhibitors. It is a reversible, specific, and mainly peripherally acting COMT inhibitor designed for concomitant administration with levodopa preparations. Entacapone prolongs the clinical response to levodopa.

List of Excipients

Tablet core:

Microcrystalline cellulose
Mannitol
Croscarmellose sodium
Hydrogenated vegetable oil
Magnesium stearate

Film-coating:

Hypromellose
Polysorbate 80
Glycerol 85%
Sucrose
Yellow iron oxide (E172)
Red iron oxide (E172)
Titanium dioxide (E171)
Magnesium stearate

Pack sizes and marketing

Amber glass bottles (hydrolytic class III) with white tamper-resistant polypropylene closures containing 30, 60 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

EU/1/98/081/001-003

Date of first authorisation: 22 September 1998
Date of latest renewal: 03 September 2008

Drugs

Drug Countries
COMTAN Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, France, Hong Kong, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, United States, South Africa

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