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Ipsen Pharmaceuticals Ltd

Ipsen Pharmaceuticals Ltd
7 Upper Leeson Street, Dublin 4,
Telephone: +353 1 6681377
Fax: +353 1 6602818
Summary of Product Characteristics last updated on medicines.ie: 16/07/2009
SPC Decapeptyl (triptorelin) 3-month

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 16/07/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01-Aug-2008
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

6.3 Shelf Life

The shelf life expiry date of the powder for injection shall not exceed three years from the date of its manufacture.

The shelf life expiry date of the solvent shall not exceed five years from the date of its manufacture.

The product should be used immediately after reconstitution.
Updated on 27/08/2008 and displayed until 16/07/2009
Reasons for adding or updating:
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   01/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 6.6 : Instructions for use of safety needle have been added.
Updated on 25/01/2007 and displayed until 27/08/2008
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
Date of revision of text on the SPC:   08/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

New indication in Precocious Puberty
Updated on 19/05/2005 and displayed until 25/01/2007
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Updated on 16/08/2003 and displayed until 19/05/2005
Reasons for adding or updating:
  • New SPC for medicines.ie
Updated on 30/06/2003 and displayed until 16/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   triptorelin pamoate

Versions

 
16/07/2009 to Current
27/08/2008 to 16/07/2009
25/01/2007 to 27/08/2008
19/05/2005 to 25/01/2007
16/08/2003 to 19/05/2005
30/06/2003 to 16/08/2003
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  • Contact Us

Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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