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Pharmacia Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 26/05/2009
SPC Aromasin

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 26/05/2009 and displayed until Current
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:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 updated with adverse drug reactions of hepatitis
Updated on 15/08/2008 and displayed until 26/05/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of Excipients
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   08-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

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 18/09/2007 and displayed until 15/08/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.4 – Update on osteoporosis andreformatting

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

5.1 – efficacy results updated  

Updated on 13/09/2005 and displayed until 18/09/2007
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
  • Change to section 10 (date of (partial) revision of the text
Updated on 03/06/2005 and displayed until 13/09/2005
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 (date of (partial) revision of the text
Updated on 01/03/2005 and displayed until 03/06/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 17/12/2004 and displayed until 01/03/2005
Reasons for adding or updating:
  • Change to section 1 - trade name
  • 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 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 25/03/2003 and displayed until 17/12/2004
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
Updated on 21/08/2001 and displayed until 25/03/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 25/07/2001 and displayed until 21/08/2001
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 02/04/2001 and displayed until 25/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 10/08/2000 and displayed until 02/04/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 25/05/2000 and displayed until 10/08/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 21/02/2000 and displayed until 25/05/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
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