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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: 25/01/2012
SPC Decapeptyl (triptorelin) SR

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 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

$0Minor changes are required to section 2, 5.1, 6.3, 6.6.$0$0Major changes are required to sections4.3, 4.4, 4.6, 4.7, 4.8$0$0
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-Jul-2009
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 22/07/2009 and displayed until 27/06/2011
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01-Nov-2007
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 two 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 22/07/2009
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 Instruction for use and handling
 
Inclusion of Instruction for use of safety needle.
 
 
Updated on 16/08/2003 and displayed until 27/08/2008
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 acetate

Versions

 
25/01/2012 to Current
27/06/2011 to 25/01/2012
22/07/2009 to 27/06/2011
27/08/2008 to 22/07/2009
16/08/2003 to 27/08/2008
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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