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MSD Ireland (Human Health) Limited
Pelham House, South County Business Park, Leopardstown, Dublin 18, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com
Summary of Product Characteristics last updated on medicines.ie: 13/04/2011
SPC Diprobase Cream

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 13/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   25-Mar-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
SmPC update following legal entity change to MSD.
Updated on 19/01/2010 and displayed until 13/04/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   01-Jun-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
2
Addition of:     "Exipients include: Chlorocresol 0.10% w/w and Cetostearyl alcohol 7.20% w/w"
and                "a full list of" added in between "for" and "excipients"
and                "section" added before "6.1"

4.4
Deletion of     "None stated"
Addition of     "Diprobase Cream contains Chlorocresol which may cause allergic reaction and Cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis)"

4.6
Addition of    "Fertility" to Pregnancy and lactation title

6.1
Deletion of full stop after "purified water"

6.3
Deletion of  "15, 50 and 100gm aluminium tubes – 60 months"
Addition of "Aluminium tubes: 5 years"
Deletion of "500gm polypropylene jar with pump presentation – 36 months"
Addition of "Plastic jar with pump: 3 years"

6.5
Addition of "g" after 15 and 50
Deletion of "m" from 100gm
New paragraph from "A 500 g..."
Deletion of space between 500 and g
change from upper case P to lowercase on all "polypropylene" and "polyethylene" entires in paragraph
"The pump system.." changed to "This pump system.."

6.6
Addition of "Any unused product or waste material should be disposed of in accordance with the local requirements"

9
Deletion of 26 November
Addition of 6 October
Updated on 26/08/2009 and displayed until 19/01/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   30-Jun-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

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

Changed from: Rarely, mild skin reactions have been observed.

Changed to: Skin reactions including pruritus, rash, erythema, skin exfoliation, burning sensation, hypersensitivity, pain, dry skin and bullous dermatitis have been reported with product use.

Section 9 - updated renewal date

Section 10 - updated revision of text date
Updated on 06/04/2009 and displayed until 26/08/2009
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 6.1 - excipient name corrected from cetomacrogol to macrogol cetostearyl esther
 
Section 9 - updated date of renewal of authorisation
 
Section 10 - updated date of renewal of text
Updated on 11/03/2008 and displayed until 06/04/2009
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:   02/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 6.3

 

Shelf life changed from 5 years to 60 months for 15, 50 and 100gm aluminium tubes and 36 months for 500gm polypropylene jar with pump presentation.

 

Section 6.5

 

Changed from:

 

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

 

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

 

Or

 

500g 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.

Not all pack sizes may be marketed.

 

To:

 

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

 

A 500 g Polypropylene jar with a Polyethylene follower plate and a pump system. This pump system consists of a Polypropylene pump cylinder, a Polypropylene head, a Polypropylene pump body and a Polyethylene piston with a glass valve and a Polyethylene valve.

Not all pack sizes may be marketed.

 

Section 10 – Date of revision of text updated

 
Updated on 12/11/2007 and displayed until 11/03/2008
Reasons for adding or updating:
  • 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:   prescription only

Free-text change information supplied by the pharmaceutical company
  Changed from:

 

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

 

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

Not all pack sizes may be marketed.

 To:

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

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

or

500g 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.

Not all pack sizes may be marketed.
Updated on 07/12/2005 and displayed until 12/11/2007
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Updated on 19/07/2005 and displayed until 07/12/2005
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Updated on 28/05/2003 and displayed until 19/07/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Not Known