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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

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: 04/04/2011
SPC Diprobase Ointment

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 04/04/2011 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:   21-Mar-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to the SmPC following the approval of the change in legal entity to MSD.
Updated on 04/12/2009 and displayed until 04/04/2011
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 6. 3 - Shelf Life
  • 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:   01-Nov-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.6 - change of heading from "Pregnancy & lactation" to "Fertility, pregnancy & lactation"

Section 6.3 - increase of shelf life from 24 to 36 months for 500gm plastic jar with screw cap.  460gm pump dispenser pack removed

Section 6.5 - 500gm tube removed.  500gm polypropylene jar added.  460gm polypropylene piston pack removed.

Section 10 - Date of Revision of Text changed from July 2009 to November 2009
Updated on 14/09/2009 and displayed until 04/12/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 changed from:

Rarely, mild skin reactions have occurred.

To:

Skin reactions including pruritus, rash, erythema, skin exfoliation, burning sensation, hypersensitivity, pain, dry skin and bullous dermatitis have been reported with product use.
Updated on 19/11/2007 and displayed until 14/09/2009
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:   10/2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 9 and 10 updated to reflect renewal of product licence
Updated on 13/08/2003 and displayed until 19/11/2007
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 20/08/2001 and displayed until 13/08/2003
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 09/04/2001 and displayed until 26/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 09/04/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  no active ingredients