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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: 13/07/2011
SPC ANUGESIC HC Suppositories

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 13/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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-Jun-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
SmPC Updates to sections 2 (Qualitative and Quantitative composition); 4.6 and 6.6 (Headings only); 7 (MAH ); 10 (Date of revision of text)
Updated on 02/01/2008 and displayed until 13/07/2011
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
Date of revision of text on the SPC:   07/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

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
Updated on 30/08/2007 and displayed until 02/01/2008
Reasons for adding or updating:
  • Improved electronic presentation
Date of revision of text on the SPC:   10/2005
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 2 and 3 Improved Electronic presentation
Updated on 24/08/2006 and displayed until 30/08/2007
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   10/2005
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Generic Name(s): Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Bismuth Subgallate, Hydrocortisone Acetate, Pramoxine Hydrochloride, Zinc Oxide
Reason for Submission: 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

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