Summary of Product Characteristics
last updated on the eMC:
16/06/2010
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 16/06/2010 and displayed until Current
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Reasons for adding or updating:
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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 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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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 - Pharmacological Properties
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Change to section 6.1 - List of Excipients
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 7 - Marketing Authorisation Holder
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 01-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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2. Qualitative and quantitative composition
4.2 Posology and method of administration
Posology
Elderly
Renal and hepatic impairment
Method of administration
Self administration by the patient
4.3 Contraindications
4.4 Special warnings and special precautions for use
Haematological toxicity
Renal and hepatic impairment
Elderly
Fertility
4.5 Interactions with other medicinal products and other forms of interactions
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8. Undesirable effects
4.9. Overdose
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6.1 List of excipients
6.6 Special precautions for disposing and other handling
7.0 Marketing Authorisation Holder ( new address )
9.0 Data of first authorisation/renewal of the authorisation
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Updated on 07/11/2008 and displayed until 16/06/2010
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Reasons for adding or updating:
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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: 20-Feb-2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Date of revision of text from 14th April 2004 to 20th of Feb 2006
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Updated on 05/02/2008 and displayed until 07/11/2008
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Reasons for adding or updating:
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