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sanofi-aventis
Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4035600
Fax: +353 1 4035687
Medical Information e-mail: IEmedinfo@sanofi-aventis.com
Summary of Product Characteristics last updated on medicines.ie: 26/05/2010
SPC Oruvail 200mg Prolonged Release Capsules, Hard

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 26/05/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   01-Jan-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Update
Section 1- Change product name
Section 2- Addition of excipients
Section 3 - Change pharmaceutical form
Updated on 01/09/2009 and displayed until 26/05/2010
Reasons for adding or updating:
  • Change to improve clarity and readability
Date of revision of text on the SPC:   01-Jul-2007
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Change to improve readability
Updated on 11/07/2007 and displayed until 01/09/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update sections
4.2 - treatment for shortest duration.
4.3 - use in patients who suffer from asthmatic attacks and peptic ulcer.
4.4 - risk of gastrointestinal toxicity, monitoring in patients with hypertension, warning on female fertility.
4.5 - addition of revised anticoagulant statement and use with SSRI's.  Also ACE inhibitors.
4.8 - revised gastrointestinal effects and statement on associated risk of arterial thrombotic events.
10 - date of revision.
 
 
 
Updated on 05/12/2006 and displayed until 11/07/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   11/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update section 4.2 - Use in patients with impaired hepatic/renal function
Update section 4.3, 4.4, 4.5, 4.6, 4.8 - Additional safety information
Updated on 13/11/2006 and displayed until 05/12/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update Section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Update Section 10 - Change date of revision.
Updated on 29/08/2005 and displayed until 13/11/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Ketoprofen