DUPHASTON Film-coated tablet Ref.[50849] Active ingredients: Dehydroprogesterone

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Product name and form

Duphaston 10 mg film-coated tablets.

Pharmaceutical Form

Film coated tablet.

A round, biconvex, scored, white film-coated tablet, one side with inscription ‘155’ on either side of the score.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each film coated tablet contains 10 mg Dydrogesterone.

Excipients: each tablet contains 111.1 mg of lactose monohydrate.

For a full list of excipients see section 6.1.

Active Ingredient Description
Dehydroprogesterone

Dydrogesterone is an orally-active progestogen having an activity comparable to parenterally administered progesterone.

List of Excipients

Core:

Lactose Monohydrate
Maize Starch
Hypromellose
Colloidal Anhydrous Silica
Magnesium Stearate

Film Coating:

Hypromellose
Macrogol 400
Titanium Dioxide (E171)

Pack sizes and marketing

Cartons of 42 or 60 blister packed tablets in Al/PVC blister strips.

Not all packs sizes may be marketed.

Marketing authorization holder

Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Marketing authorization dates and numbers

PA2010/010/001

Date of first authorisation: 28 January 1985
Date of last renewal: 28 January 2010

Drugs

Drug Countries
DUPHASTON Austria, Brazil, Cyprus, Germany, Ecuador, Estonia, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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