PROGYNOVA 1mg Coated tablet Ref.[27703] Active ingredients: Estradiol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Product name and form

Progynova 1mg Tablets.

Pharmaceutical Form

Pale yellow sugar coated tablet for oral administration.

Qualitative and quantitative composition

Each memo pack contains 28 tablets each containing estradiol valerate 1.0 mg.

Excipients with known effect:

Lactose monohydrate and sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Estradiol

Estradiol, is chemically and biologically identical to endogenous human estradiol. It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms. Oestrogens prevent bone loss following menopause or ovariectomy.

List of Excipients

Lactose monohydrate
Maize starch
Povidone 25,000
Talc
Magnesium stearate [E572]
Sucrose
Povidone 700,000
Macrogol 6,000
Calcium carbonate [E170]
Titanium dioxide [E171]
Glycerol 85% [E422]
Montan glycol wax
Ferric oxide pigment
Purified water

Pack sizes and marketing

Container consists of aluminium foil and PVC blister strips packed in a cardboard carton.

Presentation: Carton containing memo-packs of either 1 × 28 tablets or 3 × 28 tablets.

Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Marketing authorization dates and numbers

PL 00010/0556

1 May 2008

Drugs

Drug Countries
PROGYNOVA Austria, Australia, Germany, Spain, Finland, France, Israel, Malta, Netherlands, New Zealand, Singapore, United Kingdom, South Africa

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