PROGYNOVA Transdermal patch Ref.[27704] Active ingredients: Estradiol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Product name and form

Progynova TS 50 micrograms/24 hours Transdermal Patch.

Pharmaceutical Form

Transdermal patch.

Oval transdermal patch with a translucent homogenous matrix on a transparent carrier film.

Qualitative and quantitative composition

Each 12.5 cm² patch contains 3.8 mg estradiol (formed from 3.9 mg estradiol hemihydrate), releasing a nominal 50 micrograms of estradiol per 24 hours.

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

Isooctyl acrylate/acrylamide/vinyl acetate copolymer
Ethyl oleate
Isopropyl myristate
Glycerol monolaurate
Polyester release liner
Polyethylene backing film

Pack sizes and marketing

Each patch is sealed in a multilaminate pouch containing a desiccant. The desiccant consists of sodium alumino silicate;

Pack of 4 or 12 patches.

(Not all pack sizes may be marketed).

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00010/0560

11 July 2010

Drugs

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

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