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CONBRIZA Film-coated tablet (2020)

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”.

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.

Chemical substance
Description
Bazedoxifene
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
Authorization dates

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

Date of first authorisation: 17 April 2009

Date of latest renewal: 17 April 2014

Marketing authorization number:

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