ESTRADOT Transdermal patch Ref.[7705] Active ingredients: Estradiol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

Product name and form

Estradot 25 micrograms/24 hours, transdermal patch.

Pharmaceutical Form

Transdermal patch.

Rectangular patch with rounded corners, comprising a pressure-sensitive adhesive layer containing estradiol, with a translucent polymeric backing on one side and a protective liner on the other.

Qualitative and quantitative composition

2.5 cm² patch containing 0.39 mg estradiol (as hemihydrate) with a release rate 25 micrograms 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

Adhesive matrix:

Acrylic adhesive
Silicone adhesive
Oleyl alcohol
Dipropylene glycol
Povidone (E1201)

Backing layer:

Ethylene/vinyl acetate copolymer
Vinylidene chloride/methyl acrylate copolymer laminate

Release liner:

Fluoropolymer-coated polyester film

Pack sizes and marketing

Each Estradot patch is individually sealed in an aluminium laminate sachet.

Sachets may be provided in cartons of 2, 8, 24 and 26.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

Marketing authorization dates and numbers

PL 00101/0703

16 September 2004 / 31 July 2006

Drugs

Drug Countries
ESTRADOT Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, Croatia, Ireland, New Zealand, United Kingdom, South Africa
 
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