ESTRADERM Transdermal patch Ref.[27763] Active ingredients: Estradiol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK

Product name and form

Estraderm MX 25.

Pharmaceutical Form

Estraderm MX is a square-shaped, self-adhesive, transparent, transdermal patch for application to the skin surface. Each patch comprises an impermeable polyester backing film, an adhesive matrix containing oestradiol and an oversized protective liner which is removed prior to application of the patch to the skin. Estraderm MX releases oestradiol into the circulation via intact skin at a low rate for up to 4 days.

Cross section:

DOSAGE STRENGTHSESTRADERM
MX 25
Nominal rate of estradiol release25 micrograms/day
Oestradiol content0.75mg
Drug-releasing area11 cm²
Imprint
(on backing film)
Product logo
CG GRG

Qualitative and quantitative composition

The active ingredient is estra-1, 3,5(10)-triene-3,17β-diol (oestradiol hemihydrate).

Patches contain 0.75 mg active substance corresponding to a surface area of 11cm².

For a 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

Acrylate, methacrylate, isopropyl palmitate, polyethylene terephthalate, ethylenevinylacetate copolymer, silicone coating (on the inner side of the protective release liner which is removed before patch application).

Pack sizes and marketing

Each system is individually heat sealed in a paper/aluminium/polyethylene foil pouch. Eight or twenty four Estraderm MX pouches are placed in an appropriately sized carton which comprises the finished product (one or three month’s treatment respectively).

Marketing authorization holder

Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK

Marketing authorization dates and numbers

Estraderm MX 25: PL 20011/0064

12 September 1997 / 10 February 2009

Drugs

Drug Countries
ESTRADERM Australia, Spain, Italy, Poland, United Kingdom, South Africa

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