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Servier Laboratories Ireland Ltd
Block 2, West Pier Business Campus, Old Dunleary Road, Dun Laoghaire, Co. Dublin,
Telephone: +353 1 663 8110
Fax: +353 1 663 8120
Summary of Product Characteristics last updated on medicines.ie: 15/04/2010
SPC Protelos

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 15/04/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   04-Jan-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
pyrexia was added
Updated on 02/03/2010 and displayed until 15/04/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   22-Jan-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Pyrexia (in association with hypersensitivity skin reactions) has been added.

"Hepatobiliary disorders" in section 4.8 of the SPC has been added.

Skin and subcutaneous tissue disorders have been updated
Updated on 27/11/2009 and displayed until 02/03/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   23-Oct-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
This section now includes info from post-marketing studies- increase in serum transaminase and pyrexia are now listed in the undesirable effects section.
Updated on 02/09/2009 and displayed until 27/11/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Jun-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Information on the following added:
toxic epidermal necrolysis

Respiratory, thoracic and mediastinal disorders
Frequency unknown: bronchial hyperreactivity
Updated on 19/03/2009 and displayed until 02/09/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   03/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.8 has been changed to report ADRs observed in post marketing experience: Peripheral odema and confusional state
Updated on 27/11/2007 and displayed until 19/03/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   11/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update of the SPC to include re-wording of Special Warnings and Precautions for Use (section 4.4) and skin and subcutaneous disorders under Undesirable Effects (section 4.8).
 
Updated on 28/08/2007 and displayed until 27/11/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   08/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Changes to sections 2, 4.2, 4.4 and 4.8.
Updated on 26/10/2004 and displayed until 28/08/2007
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Strontium Ranelate