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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Summary of Product Characteristics last updated on medicines.ie: 25/05/2011
SPC Anugesic HC 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 25/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01-May-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Update to section 6.3 (shelf-life)
Updated on 27/04/2011 and displayed until 25/05/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Mar-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Updates to sections 2 (Qualitative and Quantitative Composition , 4.3 (Contraindications) and 5.1 (Pharmacodynamic properties).
Updated on 25/09/2007 and displayed until 27/04/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   09/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

AU_016

 

SPC

 

2 –    Change of active name from Pramoxine to Pramocaine

4.1 – Change of active name from Pramoxine to Pramocaine

4.9 – Change of active name from Pramoxine to Pramocaine

5.1 - Change of active name from Pramoxine to Pramocaine

10 – Update to date of revision of text

 

 

AU_017

 

6.1– Change of excipient name from BAN’s Sorbitan Monostearate’ to INN 'Sorbitan Stearate

 

AU_018

 

4.9 – Change of excipient name from BAN’s 'Methylene Blue ' to INN 'Methylthioninium ChloridePIL

Updated on 01/09/2006 and displayed until 25/09/2007
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 24/08/2006 and displayed until 01/09/2006
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
Updated on 18/08/2003 and displayed until 24/08/2006
Reasons for adding or updating:
  • Improved electronic presentation

Document Links

 
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Active Ingredients

 
   Zinc Oxide
   Benzyl Benzoate
   Pramoxine Hydrochloride
   Bismuth Oxide
   Balsam Peru
   Hydrocortisone Acetate

Versions

 
25/05/2011 to Current
27/04/2011 to 25/05/2011
25/09/2007 to 27/04/2011
01/09/2006 to 25/09/2007
24/08/2006 to 01/09/2006
18/08/2003 to 24/08/2006
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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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