UTOVLAN Tablet Ref.[7887] Active ingredients: 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

Utovlan 5 mg tablets.

Pharmaceutical Form

Tablet.

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

Qualitative and quantitative composition

Each tablet contains 5mg norethisterone.

Excipient(s) with known effect: Each tablet contains 62.25 mg lactose (as monohydrate).

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

Maize starch
Polyvidone
Magnesium stearate
Lactose monohydrate

Pack sizes and marketing

Pvc/foil blister packs of 30 and 90 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 00057/1054

Date of first authorisation: 15th July 2002
Date of latest renewal: 15th February 2003

Drugs

Drug Countries
UTOVLAN United Kingdom

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