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ViiV Healthcare UK Ltd
Stockley Park West, Uxbridge, Middlesex,, UB11 1BT, UK
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328

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: 10/02/2012
SPC Retrovir10 mg/ml IV 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 10/02/2012 and displayed until Current
Reasons for adding or updating:
  • 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 10 date of revision of the text
Date of revision of text on the SPC:   06-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - information regarding exacerbation of anaemia in patient co-infected with HCV and receiving ribavirin.
Section 4.5 - harmonise information on the interaction between zidovudine and atovaquone.
Section 4.6 - reflection of the increased first trimester of zidovudine during pregnancy.
Section 10 - updated with new date of revision of text.
Updated on 09/08/2011 and displayed until 10/02/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 7 and 8 - Update to Marketing Authorisation Holder and Number
Section 10 - Updated date of revision
Updated on 12/12/2008 and displayed until 09/08/2011
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 4.8 - Undesirable Effects
  • 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:   01-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 -Switch from body surface area (BSA)-based dosing (mg/m2) to bodyweight-based dosing (mg/kg), and the change from three times a day dosing to twice daily (BID) dosing

Section 4.4 - correction typographical error - superscripts

Section 4.6 - correction typographical error - superscripts

Section 4.8 - correction typographical error - superscripts

Section 5.2 - Renal impairment updated

Section 10 - Approval date
Updated on 15/11/2007 and displayed until 12/12/2008
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 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   10/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Update to section 4.2 - Dosage adjustments in patients with haematological adverse reactions + Dosage in hepatic impairment

Update to section 4.4 and 4.8 - Osteonecrosis updates

Update to section 5.2 - Pharmacokinetics/distribution data in adults and children.
Updated on 15/12/2006 and displayed until 15/11/2007
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12/2006
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 26/09/2005 and displayed until 15/12/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 25/08/2005 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 4.8 - Undesirable Effects
Updated on 14/01/2005 and displayed until 25/08/2005
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
Updated on 04/06/2004 and displayed until 14/01/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 18/05/2004 and displayed until 04/06/2004
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 17/11/2003 and displayed until 18/05/2004
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 3 - pharmaceutical form
Updated on 16/06/2003 and displayed until 17/11/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 10/03/2003 and displayed until 16/06/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 7 - Marketing Authorisation Holder
Updated on 18/09/2002 and displayed until 10/03/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 23/05/2002 and displayed until 18/09/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 27/06/2001 and displayed until 23/05/2002
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 12/02/2001 and displayed until 27/06/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 27/01/2000 and displayed until 12/02/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 27/01/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  zidovudine