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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

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Summary of Product Characteristics last updated on the eMC: 15/02/2012
SPC Daraprim 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 15/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.6  updated with a reference to malaria
4.9  updated to remove the reference to gastric lavage
10   updated with new date of revision of text
Updated on 13/02/2006 and displayed until 15/02/2012
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 06/02/2006 and displayed until 13/02/2006
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 06/02/2006 and displayed until 06/02/2006
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 05/08/2003 and displayed until 06/02/2006
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 10 (date of (partial) revision of the text
Updated on 13/05/2003 and displayed until 05/08/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 25/04/2003 and displayed until 13/05/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 09/10/2001 and displayed until 25/04/2003
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • 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 4.8 - 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 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 21/08/2001 and displayed until 09/10/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 21/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   pyrimethamine