BREVINOR Tablet Ref.[27868] Active ingredients: 17 alpha-Ethinylestradiol Norethisterone

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

Product name and form

Brevinor 0.5 milligram (mg)/35 micrograms (μg) Tablets.

Pharmaceutical Form

Tablet.

Blue, flat, circular, bevel-edged tablet inscribed ‘SEARLE’ on one side and ‘BX’ on the other side.

Qualitative and quantitative composition

Each tablet contains 0.5 milligrams norethisterone and 35 micrograms ethinylestradiol.

Excipients with known effect:

Each tablet contains lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
17 alpha-Ethinylestradiol

Ethinylestradiol is chemically and biologically identical to endogenous human oestradiol. It substitutes for the loss of estrogen production in menopausal women, and alleviates menopausal symptoms. Estrogens prevent bone loss following menopause or ovariectomy.

Norethisterone

Norethisterone has progestational actions similar to those of progesterone, but is a more potent inhibitor of ovulation and has weak oestrogenic and androgenic properties. It is used to treat a number of disorders of the menstrual cycle.

List of Excipients

Maize starch
Polyvidone
Magnesium stearate
Lactose
E132

Pack sizes and marketing

Pvc/foil blister packs of 21 and 63 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00057/0935

27 June 2002

Drugs

Drug Countries
BREVINOR Australia, New Zealand, United Kingdom

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