Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Rottapharm Ltd, Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
DERMESTRIL-Septem 25 micrograms/24hours Transdermal Patch.
| Pharmaceutical Form |
|---|
|
Transdermal patch. Each patch is transparent, colourless, slightly opaque with an elliptical shape and a printed identification code, and covered by a rectangular, transparent protective liner. |
One transdermal patch contains: 2.58 mg of estradiol hemihydrate equivalent to 2.5 mg estradiol/11.25 cm² delivering 25 micrograms of estradiol in 24 hours.
Excipient(s): 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 |
|---|
|
Estradiol-containing adhesive matrix: acrylic copolymers (Durotak 387-2353; Durotak 387-2287) |
DERMESTRIL-Septem 25 is packed in a cardboard box containing 4 or 12 transdermal delivery systems sealed individually in protective sachets consisting of 4 layers: Surlyn, heat-sealable material (inner layer), aluminium foil, polyethylene and paper (outer layer).
Not all pack sizes may be marketed.
Rottapharm Ltd, Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
PA0868/002/004
Date of first authorisation: 23 August 1999
Date of last renewal: 1 December 2008
| Drug | Countries | |
|---|---|---|
| DERMESTRIL | Germany, France, Italy |
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