Summary of Product Characteristics
last updated on the eMC:
01/04/2010
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 01/04/2010 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 10 date of revision of the text
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| Date of revision of text on the SPC: 18-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 Marketing authorisation Holder: name changed to Pfizer Limited
Section 10: PL number changed to PL 00057/0970
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Updated on 18/01/2010 and displayed until 01/04/2010
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 05-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2 Correction to administration dose (already corrected on eMC),
Section 4.5 Addition of information regarding sorafenib.
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Updated on 05/11/2009 and displayed until 18/01/2010
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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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| Date of revision of text on the SPC: 01-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Correction to dosage error in section 4.2
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Updated on 20/07/2009 and displayed until 05/11/2009
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Reasons for adding or updating:
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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 5.1 - Pharmacodynamic Properties
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SPC Retired pending re-submission
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| Date of revision of text on the SPC: 01-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4
Administration of vaccines
Addition of cardiotoxic drugs and anthracyclines
Section 4.5
Paclitaxel can cause increased plasma-concentrations of doxorubicin and/or its metabolites when given prior to doxorubicin. Certain data indicate that a smaller increase is observed when doxorubicin is administered prior to paclitaxel.
Section 5.1
ATC code: L01DB01
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Updated on 30/01/2008 and displayed until 20/07/2009
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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