OVESTIN Vaginal cream Ref.[8363] Active ingredients: Estriol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Ovestin 1 mg cream.

Pharmaceutical Form

Vaginal cream.

Homogeneous, smooth, white to nearly white mass of creamy consistency.

Qualitative and quantitative composition

1mg estriol in 1g cream.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Estriol

Estriol is a steroid, a weak estrogen, specifically an agonist of the estrogen receptors ERα and ERβ. It is one of three major endogenous estrogens, the others being estradiol and estrone.
List of Excipients

Octyldodecanol
Cetyl palmitate
Glycerin
Cetyl alcohol
Stearyl alcohol
Polysorbate 60
Sorbitan stearate
Chlorhexidine dihydrochloride
Lactic acid
Sodium hydroxide to pH 4
Purified water

Pack sizes and marketing

15g Collapsible aluminium tube with styrene acrylonitrile (copolymer) applicator.

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PL 39699/0058

20 August 1982/ 16 December 1999

Drugs

Drug Countries
OVESTIN Austria, Australia, Germany, Ecuador, Estonia, Finland, Ireland, Israel, Lithuania, Mexico, New Zealand, Poland, Romania, United Kingdom
 
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