Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
Telephone: +44 (0)1992 467 272
Fax: +44 (0)1992 479 292
Medical Information e-mail: medicalinformationuk@merck.com

Summary of Product Characteristics last updated on the eMC: 18/02/2011
SPC Diprobath

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 18/02/2011 and displayed until Current
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-Jan-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

As a result of the legal entity approval from Schering-Plough to MSD the following SmPC sections have been updated accordingly:

Section 7, 8 and 10
Updated on 24/05/2010 and displayed until 18/02/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   13-May-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 2 :  Minor amendment to update in line with the current EU QRD template to include "For a full list of excipients, see section 6.1".


Section 6.5 :
Revised to include the newly approved polypropylene screw cap.

Updated on 02/06/2008 and displayed until 24/05/2010
Reasons for adding or updating:
  • 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:   01-Jul-2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Sections 9 & 10 updated following renewal of product licence
Updated on 24/01/2002 and displayed until 02/06/2008
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/08/2001 and displayed until 24/01/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 26/07/2001 and displayed until 20/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 26/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   isopropyl myristate
   light liquid paraffin