FEMSEVEN Transdermal patch Ref.[28030] Active ingredients: Estradiol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

Product name and form

FemSeven 50,

50 micrograms/24 hours,

Transdermal patch.

Pharmaceutical Form

Transdermal patch.

Octagonal, transparent, flexible, rounded-edge transdermal matrix patch located on an oversized removable protective liner.

Qualitative and quantitative composition

Each patch contains 1.5 mg of estradiol hemihydrate in a patch size of 15 cm², releasing 50 micrograms of estradiol per 24 hours.

For the full list of excipients, see 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

Backing layer:

Transparent polyethylene terephthalate (PET) foil.

Adhesive matrix:

Styrene-isoprene block copolymer, glycerine esters of completely hydrogenated resins.

Pack sizes and marketing

The container (primary packaging) consists of a sealed laminated sachet. This comprises layers of food grade paper/polyethylene/aluminium/ethylene copolymer.

Package sizes: Carton of 4 and 12 patches.

Marketing authorization holder

Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

Marketing authorization dates and numbers

PL 49876/0007

14/12/2005 / 14/12/2010

Drugs

Drug Countries
FEMSEVEN Austria, Italy, United Kingdom

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