Summary of Product Characteristics
last updated on the eMC:
12/08/2009
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 12/08/2009 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: 17-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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7 Marketing authorisation holder
Shire Pharmaceuticals Ireland Limited
5 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
8 Marketing authorisation number(s)
5 mg: 27303/001, 10 mg: 27303/002, 20 mg: 27303/003
10 Date of revision of the text
17 June 2009
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Updated on 21/09/2006 and displayed until 12/08/2009
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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 10 date of revision of the text
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Transfer of Marketing Authorisation Holder
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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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Change of name of marketing authorisation holder to UCB Pharma Ltd.
Change of date of partial revision of the text - June 2006
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Updated on 26/09/2005 and displayed until 21/09/2006
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Updated on 11/07/2005 and displayed until 26/09/2005
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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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 4.6 - Pregnancy and Lactation
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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 5.3 - Preclinical Safety Data
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Change to section 6. 3 - Shelf Life
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 05/07/2005 and displayed until 11/07/2005
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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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 4.6 - Pregnancy and Lactation
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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 5.3 - Preclinical Safety Data
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Change to section 6. 3 - Shelf Life
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 01/03/2005 and displayed until 05/07/2005
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Updated on 02/10/2003 and displayed until 01/03/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 22/08/2001 and displayed until 02/10/2003
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Reasons for adding or updating:
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