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Sanofi Pharma Bristol-Myers Squibb SNC
174 avenue de France, F-75013 Paris, , France
Telephone: +353 1 403 5600 - Plavix
Telephone: +353 1 291 3800 - Aprovel and Co-Aprovel
Fax: +353 1 291 3899 - Aprovel and Co-Aprovel
Fax: +353 1 403 5687 - Plavix
Medical Information Direct Line: Freephone: 1 800 749 749 - Aprovel and Co-Aprovel
Medical Information e-mail: medical.information@bms.com - Aprovel and Co-Aprov
Medical Information e-mail: IEmedinfo@sanofi-aventis.com - Plavix
Medical Information Facsimile: +44 (0)1895 523 677 - Aprovel and Co-Aprovel
Summary of Product Characteristics last updated on medicines.ie: 07/02/2011
SPC DuoPlavin 75mg/75mg Film Coated 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 07/02/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   20-Dec-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Update to sections 4.2 “Posology and method of administration”, 4.4 “Special warnings and precautions for use”, 4.5 “Interaction with other medicinal products and other forms of interaction” and 5.2 “Pharmacokinetic properties” of clopidogrel/acetylsalicylic acid (ASA) SPC to include new information on the variability of response to clopidogrel due to either genetic variations of the CYP2C19 enzyme or concomitant use of drugs that inhibit the CYP2C19 enzyme such as proton pump inhibitor (PPI). Section 4.8 has been amended with minor details on the CURE study.
Updated on 12/11/2010 and displayed until 07/02/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   06-Aug-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

  • Section 4.2- removal of text: For patients older than 75 years of age, therapy should be initiated without a loading dose of clopidogrel.
  • Section 4.4- with regard to the interaction between medicinal products that inhibit CYP2C19 and reduced levels of the active metabolite of clopidogrel the following text has been added: 
    • Clinical relevance of this interaction is uncertain
    • As a precaution concomittant use of medicinal that inhibit CYP2C19 should be discouraged
    • The text relating to PPI class effect has been deleted
  • Section 4.5 - with regard to the interaction between medicinal products that inhibit CYP2C19 and reduced levels of the active metabolite of clopidogrel the following text has been added: 
    • Clinical relevance of this interaction is uncertain
    • As a precaution concomittant use of medicinal that inhibit CYP2C19 should be discouraged

Updated on 06/08/2010 and displayed until 12/11/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
None provided

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