Summary of Product Characteristics
last updated on the eMC:
25/01/2012
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 25/01/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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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: 01-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 – MA Holder’s name change
Section 8 – Marketing Authorisation Number change
and Section 10 – revision date
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Updated on 23/08/2010 and displayed until 25/01/2012
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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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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| Date of revision of text on the SPC: 01-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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SmPC
Section 4.2 Add information on switching contraception, hepatic and renal insufficiency
Section 4.3 Add liver disease history as a contraindication
Section 4.4 Add information on Bone Mineral Density and breast cancer
Section 4.5
Section 4.8
Section 5.1 Add information on bone mineral density
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Updated on 10/08/2007 and displayed until 23/08/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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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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Section 7 – MA Holder address amended from Milton Keynes to Sandwich
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Updated on 18/11/2004 and displayed until 10/08/2007
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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 4.2 - Posology and Method of Administration
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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 01/11/2002 and displayed until 18/11/2004
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 10 (date of (partial) revision of the text
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