Summary of Product Characteristics
last updated on the eMC:
13/01/2010
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 13/01/2010 and displayed until Current
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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: 01-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 13/01/2010
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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 06/03/2008 and displayed until 20/07/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 06/09/2007 and displayed until 06/03/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 12/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 - Change to the address of the MAH.
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Updated on 10/01/2007 and displayed until 06/09/2007
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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 4.3 - 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 4.8 - 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: 12/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2: additional information regarding total doxorubicin dose per cycle and about recommended starting dose
Section 4.3: addition of contraindications for intravenous use
Section 4.4: addition and reformatting of information according to body organ function
Section 4.5: addition of information regarding the possible toxicity of doxorubicin in combination with other cytotoxic and cardiotoxic drugs
Section 4.6: conclusive information regarding the embryotoxic potential of doxorubicin and its secretion into breastmilk
Section 4.8: addition and reformat of adverse events according to body organ system
Section 4.9: addition of mucositis as the main GI toxic effect of overdosing
Section 6.1: additional protective recommendations on the instructions for use or handling of the product
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Updated on 10/04/2003 and displayed until 10/01/2007
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 04/04/2003 and displayed until 10/04/2003
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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 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 6.2 - Incompatibilities
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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 19/03/2003 and displayed until 04/04/2003
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 19/03/2003 and displayed until 19/03/2003
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 20/02/2003 and displayed until 19/03/2003
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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 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 6.2 - Incompatibilities
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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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Correction of spelling/typing errors
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Updated on 08/08/2002 and displayed until 20/02/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 20/08/2001 and displayed until 08/08/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 20/07/2001 and displayed until 20/08/2001
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 06/09/1999 and displayed until 20/07/2001
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Reasons for adding or updating:
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