ESTRACYT Capsule Ref.[8734] Active ingredients: Estramustine

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

Product name and form

Estracyt Capsules.

Pharmaceutical Form

Capsule.

White, hard, gelatin capsules with “ESTRACYT” and “K Ph 750” printed in black ink.

Qualitative and quantitative composition

Estramustine phosphate 140 mg as estramustine sodium phosphate.

For the full list of excipients, see section 6.1

Active Ingredient Description
Estramustine

Estramustine is a chemical compound of oestradiol and nitrogen mustard. It is effective in the treatment of advanced prostatic carcinoma. Estramustine has a dual mode of action. The intact molecule acts as an anti-miotic agent; after hydrolysis of the carbamate ester, the metabolites act to bridge the released oestrogens and exert an anti-gonadotrophic effect.

List of Excipients

Talcum
Sodium lauryl sulfate
Colloidal silicon dioxide
Magnesium stearate
Titanium dioxide (E171)
Hard gelatin capsule
Black ink (containing black iron oxide (E172), ammonium hydroxide (E527), propylene glycol (E1520) and shellac).

Pack sizes and marketing

Brown glass bottle containing 100 capsules.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00057/0973

Date of first authorisation: 25 May 2002
Date of latest renewal: 13 Nov 2008

Drugs

Drug Countries
ESTRACYT Estonia, Spain, France, Japan, Netherlands, Singapore, Turkey, United Kingdom

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