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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: 08/12/2011
SPC Procoralan 7.5mg Tablets

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 08/12/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   30-Sep-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
In Section 7: Marketing Authorisation Holder

Change from

LES LABORATOIRES SERVIER

22, rue Garnier

92200 Neuilly-sur-Seine

France

to

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France
Updated on 09/12/2010 and displayed until 08/12/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   29-Nov-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


 

Section 4.8:

new adverse events reported during the post-marketing experience (frequency unknown). :

- rash, erythema, pruritis

- hypotension, malaise, syncope (possibly linked to bradycardia).

 

 

 
Updated on 23/11/2009 and displayed until 09/12/2010
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   23-Oct-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
The update concerns sections 4.1, 4.3, 4.4, 4.8 and 5.1 of the SPC, the labelling and the Package Leaflet. The results of a supporting large safety study, Beautiful, are also introduced in section 5.1.
Updated on 06/08/2009 and displayed until 23/11/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   18-May-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
The text in bold has been added

Section 4.8

Cardiac disorders
Common:
AV 1st degree block (ECG prolonged PQ interval)
Updated on 28/08/2007 and displayed until 06/08/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Changes to Sections 2, 3, 4.2 and 4.8.
Updated on 01/02/2006 and displayed until 28/08/2007
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Ivabradine hydrochloride