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Galderma (U.K) Ltd
Meridien House, 69-71 Clarendon Road, Watford, Hertfordshire, WD17 1DS, UK
Telephone: +44 (0)1923 208950
Fax: +44 (0)1923 208998
Medical Information e-mail: info.uk@galderma.com

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: 02/12/2011
SPC Rozex Cream

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 02/12/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes have been made to sections 4.2, 4.4, 4.6, 4.7 and 4.8.

For sections 4.4, additional warnings have been added and additional undesirable effects have been added to section 4.8.  Section 4.8 has also been re-written to include frequency of occurence of undesribale effects.
Updated on 07/09/2006 and displayed until 02/12/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   02/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7- Change of address from Church Lane, Kings Langley, Herts, WD4 8JP to Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS
Updated on 08/02/2005 and displayed until 07/09/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text
Updated on 07/02/2002 and displayed until 08/02/2005
Reasons for adding or updating:
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 17/08/2001 and displayed until 07/02/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 06/09/1999 and displayed until 17/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  metronidazole