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Almirall Limited

4 The Square, Stockley Park, Uxbridge, UB11 1ET, UK
Telephone: +44 (0) 207 160 2500
Fax: +44 (0) 208 756 3888
WWW: http://www.almirall.com
Medical Information Direct Line: 0800 0087399
Medical Information e-mail: almirall@professionalinformation.co.uk
Customer Care direct line: +44 (0) 207 160 2500
Medical Information Fax: +44 (0) 1748 828 801

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 07/02/2012
SPC Solaraze

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 07/02/2012 and displayed until Current
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 4.6 - 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 4.9 - Overdose
Date of revision of text on the SPC:   01-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.3 - clarification of the trimester of pregnancy
4.4 - further information added on skin reactions
4.5 - interaction information reworded
4.6 - reworded
4.7 - information expanded
4.8 - adverse reactions added and frequencies amended
4.9 - additional overdose information added
Updated on 25/03/2010 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:   POM
Black Triangle (CHM):   NO

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 08/06/2009 and displayed until 25/03/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of extra pack sizes - 60g, 90g & 100g
Updated on 26/09/2008 and displayed until 08/06/2009
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

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

Active Ingredients/Generics

 
  diclofenac sodium