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Wyeth Pharmaeuticals
Huntercombe Lane South
Taplow, Maidenhead
Berkshire, SL6 0PH
Tel: +44 (0)1628 604377
Fax: +44 (0)1628 666368
Prostap* SR (Leuprorelin Acetate Depot 3.75mg injection) and Prostap* 3 (Leuprorelin Acetate Depot 11.25mg injection) Prostate Cancer Licence Update
Dear customer
The Medicines and Healthcare products Regulatory Agency has recently reviewed clinical evidence to support the use of LHRH analogues in prostate cancer.
We are pleased to inform you, that the licensed indications for both Prostap* SR (Leuprorelin Acetate Depot 3.75mg injection) and Prostap* 3 (Leuprorelin Acetate Depot 11.25mg injection) have been updated to reflect current clinical evidence, contemporary treatment guidelines and UK clinical practice.
Prostap* SR and Prostap* 3 are indicated in the treatment of prostate cancer in the following settings:
- Metastatic prostate cancer
- Locally advanced prostate cancer, as an alternative to surgical castration
- As an adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer
- As an adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression Prostap* has been in routine clinical use in the UK since 1991, and the safety and efficacy profile of Prostap* is well established.
Wyeth’s Prostap* range offers liquid depot injections and flexibility of monthly or threemonthly treatments to suit individual patient needs.
The depot injections can be administered subcutaneously in a range of injection sites including the upper arm; enabling individualised, patient-orientated treatment, helping it become the choice of many clinicians for their patients and making it the world’s most widely prescribed LHRHa. (*1,*2)
A revised SmPC is now available electronically at www.medicines.org.uk.
If you would like further information about these licence changes please contact the Wyeth Medical Information team on 0845 3670098 or email ukmedinfo@wyeth.com.
Yours sincerely
Kirsty JonesOn behalf of the Prostap (*3)
Marketing Team
*1 - Persad, R. International Journal of Clinical Practice 2002;56(5):389-396
*2 MIDAS Sales Data, IMS Health, April 2007
*3 Trade Mark of, and under licence agreement with, Takeda Pharmaceutical Company Limited, Japan
John Wyeth & Brother Limited
Registered in England No. 135937
Registered Office: Huntercombe Lane South
Taplow, Maidenhead, Berkshire, SL6 0PH
