CERAZETTE Film-coated tablet Ref.[8043] Active ingredients: Desogestrel

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom

Product name and form

Cerazette 75 microgram film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

The tablet is white, round, biconvex and 5 mm in diameter. On one side it is coded KV above 2 and on the reverse side ORGANON*.

Qualitative and quantitative composition

Each tablet contains 75 microgram desogestrel.

Excipient(s) with known effect: Each tablet contains approximately 55 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Desogestrel

Desogestrel is a progestogen. Like other progestogen-only pills, desogestrel is best suited for use during breast feeding and for women who may not or do not want to use oestrogens. In contrast to traditional progestogen-only pills, the contraceptive effect of desogestrel is achieved primarily by inhibition of ovulation. Other effects include increased viscosity of the cervical mucus.

List of Excipients

Tablet core:

Silica, colloidal anhydrous
All-rac-α-tocopherol
Lactose monohydrate
Maize starch
Povidone
Stearic acid

Film coating:

Hypromellose
Macrogol 400
Talc
Titanium dioxide (E171)

Pack sizes and marketing

PVC/Aluminium blister: Each blister contains 28 tablets. Each carton contains 1, 3, 6 or 13 blisters packed separately in an aluminium laminated sachet.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom

Marketing authorization dates and numbers

PL 00025/0562

Date of first authorisation: 09 November 1998
Date of latest renewal: 12 December 2007

Drugs

Drug Countries
CERAZETTE Austria, Brazil, Ecuador, Estonia, Finland, France, Ireland, Israel, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, South Africa

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