MEDAPIA Film-coated tablet Ref.[51150] Active ingredients: Entacapone

Source: Medicines Authority (MT)  Revision Year: 2023  Publisher: Medochemie Ltd, 1-10 Constantinoupoleos Street, 3011 Limassol, Cyprus

Product name and form

MEDAPIA 200mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Brown, capsule-shaped, convex, film-coated tablets with dimension 19x10 mm.

Qualitative and quantitative composition

Each film-coated tablet of MEDAPIA contains 200mg entacapone.

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

Core:

Cellulose microcrystalline 102
Mannitol E421
Sodium starch glycolate-Type A
Magnesium stearate E572

Coating:

Hypromellose 2910 5mPa•s E464
Titanium dioxide E171
Macrogol 400
Iron oxide yellow E172
Iron oxide red E172
Iron oxide black E172
Talc E553b
Macrogol 6000

Pack sizes and marketing

The tablets are packed in:

  • Brown amber glass bottles (hydrolytic class III) containing 30 or 60 tablets, with white LDPE closures and with one white cylindrical silica gel desiccant pill. Each bottle also includes one piece of white polyurethane foam.
  • PVC/PVDC-Alu opaque blisters containing 30, 60, 100 or 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Medochemie Ltd, 1-10 Constantinoupoleos Street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

MA032/13201

Date of first authorisation: 20th of April 2018
Date of renewal: 5th January 2023

Drugs

Drug Countries
MEDAPIA Spain, Lithuania, Malta
 
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