Summary of Product Characteristics
last updated on the eMC:
08/06/2009
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 08/06/2009 and displayed until Current
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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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| Date of revision of text on the SPC: 06-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.4 (Special warnings and percautions for use) the following wording (in bold underlined) has been added.
Transient cytogenetic modifications have been observed in normal donors following G-CSF use. The significance of these changes is unknown.
Long-term safety follow up of donors is ongoing. Nevertheless, a risk of promotion of a malignant myeloid clone cannot be excluded. It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors for at least 10 years to ensure monitoring of long-term safety.
The following wording (in italics) has been removed:
Data on long-term follow-up of donors are available on a small number of subjects. Up to six years, no emerging long-term sequelae have been reported. Nevertheless, a risk of promotion of a malignant myeloid clone is possible. Therefore, it is recommended that systematic recording and tracking of the stem-cell gifts be made by the apheresis centres.
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Updated on 12/09/2008 and displayed until 08/06/2009
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Reasons for adding or updating:
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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 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6.2 - Incompatibilities
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 1 -Name of the Medicinal product
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Change to section 3 - Pharmaceutical form
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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 2 - Qualitative and quantitative composition
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Change to section 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 19-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The SPC has been harominsed in line with the requirements for SPCs. Though no substantial changes have been made to the SPC, there have been updates to the presentation of the Name of the Product, the contraindications, posology, warnings, precautions and adverse events sections have been revised in line with the new requirements. Further information has been provided in the storage, pharmaceutical form and handling instructions.
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Updated on 14/02/2005 and displayed until 12/09/2008
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 07/02/2005 and displayed until 14/02/2005
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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 4.8 - Undesirable Effects
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Updated on 18/02/2004 and displayed until 07/02/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 14/11/2003 and displayed until 18/02/2004
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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 4.8 - Undesirable Effects
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Change to section 5.3 - Preclinical Safety Data
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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 20/02/2002 and displayed until 14/11/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 19/02/2002 and displayed until 20/02/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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