Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Theramex HQ UK LTD, Sloane Square House, 1 Holbein Place, London SW1W 8NS UK
Evorel 25 Patch, Evorel 50 Patch, Evorel 75 Patch and Evorel 100 Patch.
| Pharmaceutical Form |
|---|
|
Evorel is a square shaped, transparent, self-adhesive transdermal delivery system (patch) of 0.2 mm thickness for application to the skin surface. It consists of a monolayered adhesive matrix throughout which 17β estradiol is uniformly distributed. The adhesive matrix is protected on the outside surface (from clothes etc) by a polyethylene teraphthalate backing foil, while the adhesive surface of the patch is covered by a polyester sheet (the release liner) which is removed before placing the patch on the body surface. This release liner has an S-shaped incision which facilitates easy removal from the patch. Evorel is available in four sizes corresponding to the four different concentrations: Evorel 25 is marked ‘CE25’, has a surface area of 8 sq cm and contains 1.6 mg estradiol corresponding to a release rate of 25 micrograms of estradiol in 24 hours. Evorel 50 is marked ‘CE50’, has a surface area of 16 sq cm and contains 3.2 mg estradiol corresponding to a release rate of 50 micrograms of estradiol in 24 hours. Evorel 75 is marked ‘CE75’, has a surface area of 24 sq cm. and contains 4.8 mg estradiol corresponding to a release rate of 75 micrograms of estradiol in 24 hours. Evorel 100 is marked ‘CE100’, has a surface area of 32 sq cm. and contains 6.4 mg estradiol corresponding to a release rate of 100 micrograms of estradiol in 24 hours. |
Evorel 25: 1.6 mg estradiol/patch.
Evorel 50: 3.2 mg estradiol/patch.
Evorel 75: 4.8 mg estradiol/patch.
Evorel 100: 6.4 mg estradiol/patch.
| 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 |
|---|
|
Adhesive acrylic polymer (Duro-Tak 387-2287) |
Each Evorel patch size is presented in a sealed protective pouch. The pouches are packed in a cardboard carton.
Theramex HQ UK LTD, Sloane Square House, 1 Holbein Place, London SW1W 8NS UK
Evorel 25 PL 49105/0005
Evorel 50 PL 49105/0006
Evorel 75 PL 49105/0007
Evorel 100 PL 49105/0008
1 November 1995
| Drug | Countries | |
|---|---|---|
| EVOREL | Ireland, Israel, Mexico, United Kingdom, South Africa |
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