ZOLADEX Implant, in pre-filled syringe Ref.[8359] Active ingredients: Goserelin

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK

Product name and form

Zoladex 3.6 mg Implant.

Pharmaceutical Form
Implant, in pre-filled syringe.

Qualitative and quantitative composition

Goserelin acetate (equivalent to 3.6 mg goserelin).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Goserelin	Goserelin is a synthetic analogue of naturally occurring LHRH. On chronic administration goserelin results in inhibition of pituitary LH secretion leading to a fall in serum testosterone concentrations in males and serum estradiol concentrations in females.

List of Excipients
Lactide/glycolide copolymer

Pack sizes and marketing

Single dose Safe System syringe applicator with a protective sleeve.

Marketing authorization holder

AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK

Marketing authorization dates and numbers

PL 17901/0064

Date of first authorisation: 1^st May 2001 (formerly 13.05.1993)
Date of latest renewal: 24^th November 2005

Drugs

Drug	Countries
ZOLADEX	Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States

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