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Meda Health Sales
Unit 34/35, Block A, Dunboyne Business Park, Dunboyne, Co. Meath, Dublin, Ireland
Telephone: 00 353 18026624
Fax: 00 353 18026629
Medical Information Direct Line: 00 353 1 802 6627
Medical Information e-mail: medinfo@meda.ie
Medical Information Facsimile: 00 353 1 802 6629
Summary of Product Characteristics last updated on medicines.ie: 30/05/2011
SPC Proctofoam HC

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 30/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 4.3 - Contraindications
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   01-Feb-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In section 1: the name of the product has changed to reflect the full product name
In section 4.3: typo errors have been corrected
in section 6.6: a typo error has been corrected
Updated on 14/03/2011 and displayed until 30/05/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Feb-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In section 7: the address of the MAH has changed
In section 10: the date of revision has changed to Feb 2011
Updated on 25/02/2008 and displayed until 14/03/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   02/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 7-removal of trading style of the Marketing Authorisation holder.
Updated on 02/10/2007 and displayed until 25/02/2008
Reasons for adding or updating:
  • Change to marketing authorisation holder
Date of revision of text on the SPC:   04/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change of MAH from
 

 

Meda AB

 

PO Box 906

 

SE-170 09 Solna

 

Sweden

 

Trading as:

 

Meda Pharmaceuticals

 

Regus House

 

Pegasus Business Park

 

Herald Way

 

Castle Donington

 

Derbyshire

 

DE74 2TZ
 
to
 

Meda Health Sales Ireland Limited

Office 10

Dunboyne Business Park

Dunboyne

Co Meath

Ireland

 

Trading as:

 

Meda Pharma
 
Change PA number from
 
PA 1051/4/1
to
PA 1332/5/1
Updated on 10/08/2004 and displayed until 02/10/2007
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 28/01/2004 and displayed until 10/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Hydrocortisone Acetate
  Pramocaine Hydrochloride