Summary of Product Characteristics
last updated on the eMC:
06/09/2010
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 06/09/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 28-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.5 & 6.6 updated to include an additional device, "a needle device Ferring Pen".
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Updated on 15/09/2009 and displayed until 06/09/2010
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 06-Apr-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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section 6.3 - Shelf life extended to 36 months.
section 6.5 - To replace the current CE marked syringe, used for reconstitution, with a new CE marked syringe, (the plunger material changed from ployethylene to polypropylene).
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Updated on 25/10/2007 and displayed until 15/09/2009
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Reasons for adding or updating:
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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: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 1 - The full porduct name should be "Zomacton 4mg, powder and solvent for solution for injection ".
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Updated on 17/07/2007 and displayed until 25/10/2007
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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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 4.4 - Special warnings and precautions for Use
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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 6. 3 - Shelf Life
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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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| Date of revision of text on the SPC: 09/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The following SPC sections have been updated;
1. Name of product
2. Qualitative & Quantit.
3. Pharmaceutical form
4.2 Posology and method of administration
4.4 Special warnings
4.6 Pregnancy & lactation
4.8 Undesirable effects
6.3 Shelf life
6.4 Special precautions
6.6 Instruction for use
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Updated on 09/02/2006 and displayed until 17/07/2007
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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 6.1 - List of Excipients
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Change to section 10 (date of (partial) revision of the text
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Updated on 19/08/2004 and displayed until 09/02/2006
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 26/11/2002 and displayed until 19/08/2004
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Updated on 28/08/2002 and displayed until 26/11/2002
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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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