EVISTA Film-coated tablet Ref.[8052] Active ingredients: Raloxifene

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: SUBSTIPHARM, 24 rue Erlanger, 75016 Paris, France

Product name and form

Evista 60 mg film coated tablets.

Pharmaceutical Form

Film coated tablet.

Elliptically shaped, white tablets.

Qualitative and quantitative composition

Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.

Excipient with known effect: Each tablet contains lactose (149.40 mg).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Raloxifene

As a selective oestrogen receptor modulator (SERM), raloxifene has selective agonist or antagonist activities on tissues responsive to oestrogen. It acts as an agonist on bone and partially on cholesterol metabolism (decrease in total and LDL-cholesterol), but not in the hypothalamus or in the uterine or breast tissues.
List of Excipients

Tablet core:

Povidone
Polysorbate 80
Anhydrous lactose
Lactose monohydrate
Crospovidone
Magnesium stearate

Tablet coating:

Titanium dioxide (E171)
Polysorbate 80
Hypromellose
Macrogol 400

Pack sizes and marketing

vista tablets are packed either in PVC/PVDC blisters or in high density polyethylene bottles. Blister boxes contain 14, 28, or 84 tablets. Bottles contain 100 tablets.

Not all pack sizes may be marketed in all countries.

Marketing authorization holder

SUBSTIPHARM, 24 rue Erlanger, 75016 Paris, France

Marketing authorization dates and numbers

EU/1/98/073/001
EU/1/98/073/002
EU/1/98/073/003
EU/1/98/073/004

Date of first authorisation: 5 August 1998
Date of latest renewal: 8 August 2008

Drugs

Drug Countries
EVISTA Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States, South Africa
 
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