IMVAGGIS Pessary Ref.[49986] Active ingredients: Estriol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Besins Healthcare (UK) Ltd, Lion Court, 25 Procter Street, Holborn, London, WC1V 6NY, United Kingdom

Product name and form

IMVAGGIS 0.03 mg pessary.

Pharmaceutical Form

Pessary.

White, homogenous pessaries.

Qualitative and quantitative composition

1 pessary contains 0.03 mg estriol.

Excipient with known effect: Each pessary contains a maximum of 0.008 mg butylhydroxytoluene.

For the 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

Butylhydroxytoluene
Glycerolmono/bis [(Z-R)-12-hydroxyoctadec-9-enoate]
Hard fat
Macrogol cetostearyl ether

Pack sizes and marketing

Aluminium/laminated PE strips with pessaries packed in a cardboard carton.

Pack sizes with 10, 15, 20, 24 and 30 pessaries.

Not all pack sizes may be marketed.

Marketing authorization holder

Besins Healthcare (UK) Ltd, Lion Court, 25 Procter Street, Holborn, London, WC1V 6NY, United Kingdom

Marketing authorization dates and numbers

PL 42714/0001

15/03/2018

Drugs

Drug Countries
IMVAGGIS Ireland, United Kingdom

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