Summary of Product Characteristics
last updated on the eMC:
05/10/2010
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 05/10/2010 and displayed until Current
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Reasons for adding or updating:
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 24-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.5 (Interaction with other medicinal products and other forms of interaction) busulfan and busulfan toxicity has been added.
In section 10 (Date of Revision of the Text) the date has been updated to 24-June-2010.
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Updated on 27/08/2008 and displayed until 05/10/2010
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Reasons for adding or updating:
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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 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 10 date of revision of the text
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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 1 -Name of the Medicinal product
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| Date of revision of text on the SPC: 14-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1: Name re-arranged
Section 4.4: Excipient warnings updated as per legislation
Section 4.5: 5-fluorouracil and ciclosporin added
Section 4.7: Warnings re: drowsiness, dizziness, confusion, hallucinations, convulsions or transient visual disorders.
Section 4.8: Added oral mucositis, anorexia, erythema multiforme, abnormal liver function tests, cholestatic hepatitis, jaundice and pancreatitis, agranulocytosis, neutropaenia, thrombocytopaenia and pancytopaenia, pustular eruptions, myalgia, arthralgia and transient visual disorders, psychotic disorders, including confusion and hallucinations.
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Updated on 21/09/2005 and displayed until 27/08/2008
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Reasons for adding or updating:
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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 6. 6 - Instruction for Use/Handling
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Change to section 10 (date of (partial) revision of the text
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Updated on 23/05/2003 and displayed until 21/09/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Change to section 2 - qualitative and quantitative composition
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Updated on 26/09/2002 and displayed until 23/05/2003
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Reasons for adding or updating:
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