Summary of Product Characteristics
last updated on the eMC:
22/06/2010
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 22/06/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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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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Skin and Subcutaneous disorders
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Common
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Pruritus, Skin discomfort, Skin irritation, Erythema
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Uncommon
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Dry skin, Psoriasis (aggravated)
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Not known*
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Skin oedema, Contact dermatitis
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*Adverse reactions reported from post marketing surveillance
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Updated on 24/08/2009 and displayed until 22/06/2010
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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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| Date of revision of text on the SPC: 03-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.5 - Addition of standard text ' Not all pack sizes may be marketed'.
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Updated on 01/11/2007 and displayed until 24/08/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update to section 4.8 - Undesirable effects
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Updated on 07/03/2007 and displayed until 01/11/2007
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Reasons for adding or updating:
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Removal of Black Triangle
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| Date of revision of text on the SPC: 03/2004 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Black triangle has been removed
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Updated on 03/08/2004 and displayed until 07/03/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 03/08/2004 and displayed until 03/08/2004
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 3 - pharmaceutical form
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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 4.8 - Undesirable Effects
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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. 3 - Shelf Life
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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 17/09/2003 and displayed until 03/08/2004
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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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Addition of Legal Category
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Updated on 06/08/2002 and displayed until 17/09/2003
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Reasons for adding or updating:
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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 4.1 - Therapeutic Indications
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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 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6.2 - Incompatibilities
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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 10 (date of (partial) revision of the text
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Updated on 29/04/2002 and displayed until 06/08/2002
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Reasons for adding or updating:
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