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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
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 16/07/2015
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 16/07/2015 and displayed until Current
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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   01-Jul-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as follows

4.1.   Therapeutic indications – Section updated in line with QRD

4.2.   Posology and method of administration – Section updated in line with QRD

4.3.   Contraindications - Section updated in line with QRD

4.4.   Special warnings and precautions for use -  Section updated with date on osteoporosis and Vitamin D supplementation

4.5.   Interaction with other medicinal products and other forms of interaction - Section updated in line with QRD

4.6.   Fertility, pregnancy and lactation - Section updated in line with QRD

4.8.   Undesirable effects -  section updated in line with QRD and to include data  in line CDS

5.1.         Pharmacodynamic properties - Section updated in line with QRD

5.2    Pharmacokinetic properties - Section updated in line with QRD

5.3.   Preclinical safety data – Section updated to improve electronic presentation

6.1.   List of excipients - Section updated to improve electronic presentation

Updated on 31/01/2013 and displayed until 16/07/2015
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Jan-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 5.1

The SPC was updated to reflect the updated efficacy and safety data of exemestane for the adjuvant treatment of women with EBC obtained from the primary and secondary end point analysis of the 96-OEXE-031 Main Study at 87-Months follow-up and the final analyses of the 96-OEXE-031 Bone Substudy.

 

The safety results from the 87-months follow-up study confirm the safety profile of the product is unchanged. Thus no safety updates are herewith included in the Summary of Product Characteristics.

Section 4.8

The addition of “Intergroup Exemestane Study (IES)” is included in the introductory text of section 4.8 to detail the origin of adverse event data.

Updated on 22/06/2012 and displayed until 31/01/2013
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   01-Jun-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Change to Marketing Authorisation details and PA number.
Updated on 19/10/2011 and displayed until 22/06/2012
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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Active Ingredients

 
   Exemestane