VAGIRUX Vaginal tablet Ref.[28008] Active ingredients: Estradiol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary

Product name and form

Vagirux 10 micrograms vaginal tablets.

Pharmaceutical Form

Vaginal tablet.

White, round, film coated tablets embossed with “E” on one side.

Qualitative and quantitative composition

Each vaginal tablet contains 10 micrograms estradiol (as estradiol hemihydrate).

The diameter of the tablet is approximately 6 mm.

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

Tablet core:

Hypromellose
Lactose monohydrate
Maize starch
Magnesium stearate

Film-coating:

Hypromellose
Macrogol

Pack sizes and marketing

Vagirux tablets are packed in PVC/PVDC/aluminium blister packs.

The blisters are packed into cardboard boxes accompanied by a multiple-use applicator sealed separately in foil.

Pack sizes: 18 × or 24 × vaginal tablets with one applicator in each box.

Not all pack sizes may be marketed.

Marketing authorization holder

Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary

Marketing authorization dates and numbers

PL 04854/0184

20/08/2020

Drugs

Drug Countries
VAGIRUX Estonia, Finland, Croatia, Ireland, Lithuania, Malta, Poland, United Kingdom

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