CONBRIZA Film-coated tablet

Active ingredients: Bazedoxifene

Product name and form

CONBRIZA 20 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White to off-white, capsule-shaped, film-coated tablet debossed on one side with “WY20”. The tablet is approximately 1.5 cm in length.

Qualitative and quantitative composition

Each film-coated tablet contains bazedoxifene acetate equivalent to 20 mg bazedoxifene.

Excipient with known effect: Each film-coated tablet contains 142.8 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient
Description
List of Excipients

Tablet core:

Lactose monohydrate
Microcrystalline cellulose
Pregelatinised starch (maize)
Sodium starch glycolate
Sodium lauryl sulfate
Colloidal anhydrous silica
Magnesium stearate
Ascorbic acid

Film coating:

Hypromellose
Titanium dioxide (E171)
Macrogol 400

Pack sizes and marketing

PVC/Aclar blister packs of 7, 28, 30, 84, and 90 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium

Marketing authorization dates and numbers

EU/1/09/511/001
EU/1/09/511/002
EU/1/09/511/003
EU/1/09/511/004
EU/1/09/511/005

Date of first authorisation: 17 April 2009
Date of latest renewal: 17 April 2014

Drugs

Drug
Countries
Austria, Cyprus, Estonia, Spain, Ireland, Lithuania, Netherlands, Poland