ESTRING Vaginal delivery system Ref.[7706] Active ingredients: Estradiol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Product name and form

Estring 7.5 microgram/24 hours, vaginal delivery system.

Pharmaceutical Form

Vaginal delivery system.

A slightly opaque ring, made of a silicone elastomer, with a whitish core, containing a drug reservoir of Estradiol Hemihydrate. The product has the following dimensions. Outer diameter – 55 mm; cross sectional diameter – 9 mm; core diameter – 2 mm.

Qualitative and quantitative composition

Each vaginal ring contains: Estradiol Hemihydrate 2.0 mg, corresponding to 1.94 mg estradiol.

Each ring releases estradiol at an average amount of 7.5 microgram per 24 hours, over a period of 90 days.

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

Silicone elastomer Q7-4735 A
Silicone elastomer Q7-4735 B
Silicone fluid
Barium sulfate

Pack sizes and marketing

Each ring is individually packed in a heat-sealed rectangular pouch consisting of, from outside to inside: Polyester/Aluminium foil/Low density Poly-ethylene. Each pouch is provided with a tear-off notch on one side and is packed into a cardboard carton.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Marketing authorization dates and numbers

PL 00057/1424

29/07/2013 / 10/07/2018

Drugs

Drug Countries
ESTRING Canada, Spain, Finland, France, Singapore, United Kingdom, United States, South Africa

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