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Almirall Limited

4 The Square, Stockley Park, Uxbridge, UB11 1ET, UK
Telephone: +44 (0) 1256 698 037
Fax: +44 (0) 1256 698 237
WWW: http://www.almirall.com
Medical Information Direct Line: +44 (0)1748 828 795
Medical Information e-mail: almirall@professionalinformation.co.uk.
Medical Information Facsimile: +44 (0) 1748 828 801
Summary of Product Characteristics last updated on medicines.ie: 07/02/2012
SPC Solaraze 3% Gel

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 07/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   01-Feb-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


4.3 - clarified trimester of pregnancy

4.4 - additional precautions added

4.5 - information reworded



4.6 - information reworded



4.7 - information expanded



4.8 - additional undesirable effects added and frequencies changed



4.9 - additional overdose information added
Updated on 23/03/2010 and displayed until 07/02/2012
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • 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:   13-Jan-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
The updates are to the following sections of the SmPC:

Section 6.3: the following sentence added " after 1st opening: 6 months"

Section 7: Name change of MAH from Laboratorios Almirall to "Almirall, S.A."

Section 10: to reflect latest date of revision/approval of SmPC
Updated on 04/06/2009 and displayed until 23/03/2010
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

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

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Active Ingredients

 
  Diclofenac Sodium