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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: 19/10/2011
SPC Aromasin 25 mg coated tablets

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 19/10/2011 and displayed until Current
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:   06-Oct-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
SmPC – Section 7 - MA holder name change and Section 10 – revision date.
Updated on 31/07/2009 and displayed until 19/10/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   15-May-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Section 4.8 updated with adverse drug reactions of hepatitis.
Updated on 11/11/2008 and displayed until 31/07/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • 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
Date of revision of text on the SPC:   08/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 2: Clarity on what the tablet contains.

Section 4.6: Section updated with information on women with child-bearing potential

Section 4.8: Updated with further data.

Section 6.1: Section edited.

Section 6.4: Updated statement on storage.

Section 6.6: Heading updated as per current QRD template.

Section 9: date updated with renewal approval
Updated on 03/10/2007 and displayed until 11/11/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   09/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

4.4 – Update on osteoporosis and reformatting

4.8 – Side effects: Osteoporosis and fracture added. Section also updated to reflect safety results

5.1 – efficacy results updated  

Updated on 06/10/2005 and displayed until 03/10/2007
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Updated on 03/08/2005 and displayed until 06/10/2005
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical safety data
Updated on 21/03/2005 and displayed until 03/08/2005
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Updated on 20/02/2004 and displayed until 21/03/2005
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
Updated on 26/06/2003 and displayed until 20/02/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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