NORISTERAT Solution for injection Ref.[50750] Active ingredients: Norethisterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Product name and form

Noristerat 200mg, solution for intramuscular injection.

Pharmaceutical Form

Solution for injection.

Qualitative and quantitative composition

1ml Noristerat contains 200mg norethisterone enantate in oily solution.

Excipient with known effect: 333.8 mg benzyl benzoate in 1 ml ampoule.

For the full list of excipients, see Section 6.1.

Active Ingredient Description
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

Castor oil for injection
Benzyl benzoate

Pack sizes and marketing

Carton containing one 1ml glass ampoule.

Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Marketing authorization dates and numbers

PL 00010/0548

23 February 2009

Drugs

Drug Countries
NORISTERAT Mexico, Nigeria, United Kingdom

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