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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: 06/12/2007
SPC Gerax Tablets 250 mcg, 500 mcg & 1 mg

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 06/12/2007 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   10/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 Post renewal approval commitment - type II safety variation
Updated on 19/01/2007 and displayed until 06/12/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 
 The renewal for Alprazolam was approved Jan 07. The SmPC changes reflect changes during renewal assessment.
Updated on 24/08/2006 and displayed until 19/01/2007
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 03/04/2006 and displayed until 24/08/2006
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Updated on 17/06/2003 and displayed until 03/04/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Alprazolam