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Gerard Laboratories
Unit 36, Baldoyle Industrial Estate, Grange Road, Baldoyle, Dublin 13,
Telephone: +353 1 832 2250
Fax: +353 1 466 1912
Medical Information Direct Line: +353 1800 272 272
Medical Information e-mail: sales@gerard-laboratories.ie
Summary of Product Characteristics last updated on medicines.ie: 13/08/2010
SPC Areloger 7.5mg & 15mg 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 13/08/2010 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
  • Improved electronic presentation
Date of revision of text on the SPC:   29-Oct-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 1: Name of Medicinal Product
Areloger® 7.5 mg Tablets
Areloger 7.5 mg Tablets

Areloger® 15 mg Tablets
Areloger 15 mg Tablets
Updated on 26/11/2009 and displayed until 13/08/2010
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   16-Oct-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

SPC & PIL updated following approval of the renewal.
In addition, the renewal incorporated 1) change product information being harmonised and aligned to QRD & 2) The PIL Bridging report (DK/H/814/001-002) was assessed during the renewal procedure
Updated on 06/11/2006 and displayed until 26/11/2009
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 4.3 - Contraindications
  • 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 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   06/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 
 
 Type II variation to update with regards to NSAIDS and use in pregnancy
 Update to sections; 2;4.2;4.3;4.4;4.5;4.6;4.8;5.3;6.4
Updated on 25/08/2006 and displayed until 06/11/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 16/08/2005 and displayed until 25/08/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Meloxicam