Summary of Product Characteristics
last updated on the eMC:
24/01/2008
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 24/01/2008 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 6.1 - List of Excipients
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| Date of revision of text on the SPC: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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PSUR recommendations - changes approved to sections 4.3, 4.4, 4.5,4.6, 4.8,4.9 & 6.1.
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Updated on 04/01/2008 and displayed until 24/01/2008
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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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| Date of revision of text on the SPC: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change of MAH and PL number.
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Updated on 28/01/2003 and displayed until 04/01/2008
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Reasons for adding or updating:
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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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Updated on 25/09/2002 and displayed until 28/01/2003
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Reasons for adding or updating:
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Change to section 1 - trade name
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