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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.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: 04/11/2011
SPC Zovirax 200mg Tablets

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 04/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   09-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.2 - rearrangement of one sentence only, no text changes
Updated on 22/09/2011 and displayed until 04/11/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.1 - Therapeutic Indications : reference to HSV infections in immunocompromised children

Section 5.2 - Pharmacokinetic Properties : inclusion of neonatal data

Section 10 – update to date of revision
Updated on 12/08/2011 and displayed until 22/09/2011
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 10 date of revision of the text
Date of revision of text on the SPC:   08-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.3 – Further clarification of contra-indications

Section 4.4 – Precautions in immune-compromised patients

Section 10 – Updated revision of text
Updated on 16/12/2008 and displayed until 12/08/2011
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.4 - Updated in line with guidance

Section 10 - Approval date
Updated on 12/08/2008 and displayed until 16/12/2008
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   31-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - preclinical text relocated to 5.3

Section 4.6 - Updated fertility statement

Section 5.3 - relocated preclinical text from 4.4

Section 10 - Approval date
Updated on 28/07/2008 and displayed until 12/08/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 - Renal and urinary disorders: Updated for renal pain

Section 10 - Updated with approval date
Updated on 12/03/2007 and displayed until 28/07/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 08/03/2007 and displayed until 12/03/2007
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 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 04/12/2006 and displayed until 08/03/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 08/09/2006 and displayed until 04/12/2006
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 23/07/2003 and displayed until 08/09/2006
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/04/2003 and displayed until 23/07/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 27/03/2003 and displayed until 22/04/2003
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 16/12/2002 and displayed until 27/03/2003
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
Updated on 01/07/2002 and displayed until 16/12/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 29/05/2002 and displayed until 01/07/2002
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  aciclovir