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Bayer Limited
The Atrium, Blackthorn Road, Dublin 18,
Telephone: +353 1 2999 313
Fax: +353 1 2061 456
Summary of Product Characteristics last updated on medicines.ie: 20/05/2010
SPC Germolene 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 20/05/2010 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:   14-May-2010
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
MA holder has changed from Bayer plc, UK to Bayer Ltd, Ireland.
Updated on 03/11/2009 and displayed until 20/05/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.4 - Special precautions for storage
  • 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:   09-Oct-2009
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
In section 2 Addition of wool fat as an excipient

In section 6.4 Addition of Replace closure firmly after use.

In section 6.6 Removal of Replace closure firmly after use.

In section 9 Update of last renewal date

In section 10 Date of revision October 2009
Updated on 04/08/2008 and displayed until 03/11/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   06/2008
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
 

Section 4.8 Undesirable Effects changed to:

Tartrazine (E102) and Ponceau 4R (E124) may cause allergic reactions.

Wool fat may cause local skin reactions (e.g. contact dermatitis).
Updated on 27/06/2008 and displayed until 04/08/2008
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Zinc Oxide
  Methyl Salicylate
  Phenol
  Octaphonium Chloride