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Merck Sharp & Dohme Ireland (Human Health) Limited

Merck Sharp & Dohme 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: 28/04/2011
SPC Diprosalic Ointment

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 28/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 8 - MA number
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   26-Nov-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

The PA number in section 8 was incorrect, this has been corrected.
Updated on 08/03/2011 and displayed until 28/04/2011
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:   26-Nov-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Updated sections as a result of the approval of the leagl entity change to MSD.
Updated on 14/09/2009 and displayed until 08/03/2011
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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:   01-Nov-2007
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 1


From: Diprosalic Ointment

To: Diprosalic 0.05 % w/w + 3 % w/w Ointment

 

Section 6.2


From: None stated

To: Not applicable

 

Section 6.6

 

From: Not applicable

To: No special requirements

 

Section 9

 

Date of renewal updated to 16 March 2007

 

Section 10

 

Date of revision of text updated to November 2007

 

Updated on 15/08/2007 and displayed until 14/09/2009
Reasons for adding or updating:
  • 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:   10/2003
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 9 - renewal date updated
Section 10 - date of revision of text updated
Updated on 28/05/2003 and displayed until 15/08/2007
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Salicylic Acid
   Betamethasone dipropionate

Versions

 
28/04/2011 to Current
08/03/2011 to 28/04/2011
14/09/2009 to 08/03/2011
15/08/2007 to 14/09/2009
28/05/2003 to 15/08/2007
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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