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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 Cream

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 SmPC following the approval of the change of  legal entity to MSD.
Updated on 14/09/2009 and displayed until 04/04/2011
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 18/01/2008 and displayed until 14/09/2009
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12/2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.1 - addition of sodium hydroxide to formulation
 
Section 10 - date of revision of text updated
Updated on 17/12/2007 and displayed until 18/01/2008
Reasons for adding or updating:
  • 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:   10/2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 Section 6.3 changed from:

           15, 50 and 100gm aluminium tubes - 60 months
 
           500gm polypropylene jar with pump presentation – 36 months

To:

        15, 50 and 100gm aluminium tubes - 60 months

        500gm pump presentations – 36 months

Section 6.5 changed from:

           15, 50 and 100gm aluminium epoxy lined tubes with plastic caps.

           500gm polypropylene jar and piston pack with polyethylene cap and daplen pump, disc and tube or PVC cap, polypropylene
pump, polyolefin disc and HDPE tube.

To:

        50, 100 and 15gm aluminium epoxy lined membrane tubes with plastic caps.

        500gm polypropylene piston pack with polyethylene cap and daplen pump, disc and tube or PVC cap, polypropylene
        pump, polyolefin disc and HDPE tube or 500gm polypropylene jar (container) with a polypropylene dispenser head and
        cover, the pump system consists of a polyethylene follower plate, a polypropylene pump cylinder, a polyethylene piston
        with a glass and a polypropylene valve.

 Section 10 changed from:

             04 April 2007

 To:

        October 2007

 
Updated on 22/11/2007 and displayed until 17/12/2007
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04/2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 - Shelf life changed from:
 
60 months
 
To:
 
15, 50 and 100gm aluminium tubes - 60 months
500gm polypropylene jar with pump presentation - 36 months
 
Section 10 - Date of revision of text updated
Updated on 20/08/2001 and displayed until 22/11/2007
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