SANDRENA Gel Ref.[27748] Active ingredients: Estradiol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

Product name and form

Sandrena 0.5 mg gel.

Pharmaceutical Form

Gel, single-dose container. Smooth, opalescent gel.

Qualitative and quantitative composition

Estradiol hemihydrate corresponding to 0.5 mg estradiol per single-dose container.

Excipient with known effect: propylene glycol.

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

Carbomer 974P
Trolamine
Propylene glycol
Ethanol 96%
Water, purified

Pack sizes and marketing

Single-dose aluminium foil container (PET/Aluminium/PE) supplied in packages containing 28 or 91 single-dose containers. Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

Marketing authorization dates and numbers

PL 27925/0015

Date of first authorisation: 19 November 1996
Date of latest renewal: 31 March 2010

Drugs

Drug Countries
SANDRENA Australia, Brazil, United Kingdom

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