MICROVAL Coated tablet Ref.[50579] Active ingredients: Levonorgestrel

Source: Web Search  Revision Year: 2010  Publisher: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Microval 30 microgram Tablets.

Pharmaceutical Form

Coated tablet.

White, shiny, odourless tablets with a smooth surface.

Qualitative and quantitative composition

Each tablet contains 30 micrograms of levonorgestrel.

For excipients, see 6.1.

Active Ingredient Description
Levonorgestrel

The precise mode of action of levonorgestrel as an emergency contraceptive is not known. At the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest.

List of Excipients

Tablet core:

Lactose monohydrate
Starch
Povidone 25
Talc
Magnesium stearate

Tablet coat:

Sucrose
Povidone K90
Calcium carbonate
Macrogol 6000
Carnauba wax
White beeswax

Pack sizes and marketing

Primary container: Polyvinylchloride (PVC)/Aluminium foil blister pack.

Secondary container: Cardboard carton.

Presentation: Each blister pack contains 35 tablets.

Carton contains 1 blister.

Marketing authorization holder

Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA 822/67/1

Date of first authorisation: 2nd December 1980
Date of last renewal: 2nd December 2000

Drugs

Drug Countries
MICROVAL France, Tunisia, South Africa

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