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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: 31/10/2011
SPC Zovirax Double-Strength Suspension

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 31/10/2011 and displayed until Current
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:   24-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 4.1 - reference to HSV exclusion
Section 5.2 - reference to neonate data
Section 10 - date of revision

Updated on 12/08/2011 and displayed until 31/10/2011
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 12/08/2008 and displayed until 12/08/2011
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • 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 4.6 - Updated fertility statement

Section 5.3 - Updated fertility statement

Section 10 - Approval date
Updated on 29/07/2008 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 11/07/2007 and displayed until 29/07/2008
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:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Sections 4.2, 4.4, 4.8 - product information updated with the results of a review conducted to assess risk factors for the development of neurophychiatric events in elderly and people with renal insufficiency.
 
Section 4.8 - 7 new adverse events identified. Adverse events restructured into MedDRA body system and frequency categories.
Updated on 04/12/2006 and displayed until 11/07/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 26/09/2005 and displayed until 04/12/2006
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 26/09/2005 and displayed until 26/09/2005
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
  • Pending awaiting re-submission
Updated on 26/09/2005 and displayed until 26/09/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 11/07/2005 and displayed until 26/09/2005
Reasons for adding or updating:
  • 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 5.3 - Preclinical Safety Data
Updated on 22/04/2003 and displayed until 11/07/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 08/01/2003 and displayed until 22/04/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 19/12/2002 and displayed until 08/01/2003
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • 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
Updated on 16/12/2002 and displayed until 19/12/2002
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
Updated on 05/12/2002 and displayed until 16/12/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 25/10/2002 and displayed until 05/12/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 16/08/2001 and displayed until 25/10/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 15/05/2000 and displayed until 16/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 15/05/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   aciclovir