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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: 25/01/2012
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 25/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Jun-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Minor changes are required to section 3, 4.6 (title), 5.1.
Updated on 27/06/2011 and displayed until 25/01/2012
Reasons for adding or updating:
  • Change to improve clarity and readability
Date of revision of text on the SPC:   01-May-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
User Tested
Updated on 26/04/2011 and displayed until 27/06/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   02-Sep-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


2            Qualitative and quantitative composition


Excipients:

Sodium < 1mmol (23mg)




4.4            Special warnings and special precautions for use

This medicinal product contains less than 1mmol sodium (23mg) per dose and is considered essentially ‘sodium-free’.

Updated on 16/07/2009 and displayed until 26/04/2011
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