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Roche Products Limited
Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
Telephone: +44 (0)1707 366 000
Fax: +44 (0)1707 338 297
WWW: http://www.rocheuk.com
Medical Information Direct Line: +44 (0)800 328 1629
Medical Information e-mail: medinfo.uk@roche.com
Customer Care direct line: +44 (0)800 731 5711
Medical Information Fax: +44 (0)1707 384555

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: 01/02/2011
SPC Cymevene Powder for Infusion

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 01/02/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Underlined text has been added, text with strike through deleted:

 

QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Ganciclovir 500mg (as ganciclovir sodium 5436mg).

 

 
Updated on 21/04/2006 and displayed until 01/02/2011
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 4.3 - Contra-indications
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/11/2005 and displayed until 21/04/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
  • Addition of Legal Category
Updated on 24/05/2004 and displayed until 29/11/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • 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 4.6 - 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
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 13/11/2001 and displayed until 24/05/2004
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 17/08/2001 and displayed until 13/11/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 18/09/2000 and displayed until 17/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  ganciclovir sodium