Summary of Product Characteristics
last updated on the eMC:
17/04/2009
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 17/04/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 27-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update to sections 4.8 and 5.1 with some other consequential changes to other sections. Includes data from paediatric trials and SABRE trial.
Section 10
New revision date of text: 27 March 2009.
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Updated on 15/08/2007 and displayed until 17/04/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 5.3 - Preclinical Safety Data
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.8
Addition of text
Common
(³ 1% and < 10%)
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Nervous system
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Carpal Tunnel Syndrome
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Hepatobiliary disorders
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Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase
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Uncommon
(³ 0.1% and <1%)
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Hepatobiliary disorders
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Increases in gamma-GT and bilirubin
Hepatitis
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Deletion of 3rd paragraph
Elevated gamma-GT and alkaline phosphatase have been reported uncommonly (³0.1% and <1%). A causal relationship for these changes has not been established.
5.3
Addition of text after the 4th paragraph
Reproductively toxicology
Oral administration of anastrozole to female rats produced a high incidence of infertility at 1 mg/kg/day and increased pre-implantation loss at 0.02 mg/kg/day. These effects occurred at clinically relevant doses. An effect in man cannot be excluded. These effects were related to the pharmacology of the compound and were completely reversed after a 5-week compound withdrawal period.
10
Date of revision of text 20th July 2007
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Updated on 13/07/2006 and displayed until 15/08/2007
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1
Adjuvant treatment of early breast cancer in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
Section 5.1
- Addition of underlined heading:
Primary adjuvant treatment of early breast cancer
- Addition of underlined heading with 2 paragraphs of text
Adjuvant treatment of early breast cancer for patients being treated with adjuvant tamoxifen
- Addition of Table ABCSG 8 trial endpoint and results summary
and 2 paragraphs of text
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Updated on 26/05/2006 and displayed until 13/07/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 16/02/2006 and displayed until 26/05/2006
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6.2 - Incompatibilities
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instruction for Use/Handling
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Updated on 28/06/2005 and displayed until 16/02/2006
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Updated on 06/12/2004 and displayed until 28/06/2005
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 06/08/2004 and displayed until 06/12/2004
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Updated on 25/11/2003 and displayed until 06/08/2004
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 02/12/2002 and displayed until 25/11/2003
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 11/11/2002 and displayed until 02/12/2002
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 10 (date of (partial) revision of the text
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Updated on 26/10/2001 and displayed until 11/11/2002
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 21/06/2001 and displayed until 26/10/2001
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Updated on 17/04/2001 and displayed until 21/06/2001
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Reasons for adding or updating:
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Updated on 22/11/2000 and displayed until 17/04/2001
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Reasons for adding or updating:
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