Summary of Product Characteristics
last updated on the eMC:
11/08/2011
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 11/08/2011 and displayed until Current
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Reasons for adding or updating:
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Improved Electronic Presentation
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| Date of revision of text on the SPC: 13-Jul-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 05/08/2011 and displayed until 11/08/2011
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 13-Jul-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 28/07/2011 and displayed until 05/08/2011
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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 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 13-Jul-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 2
Deletion of : For excipients, see section 6.1.
Section 4.2
Paragraph 1. Change of age from 12 to 14 years and over.
Addition of paragraph: Children and adolescents: There are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age (see also contraindications section 4.3). In children aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.
Section 4.3
Addition of paragraph: The use in children and adolescdents aged less than 14 years is contraindicated.
Section 9
Removal of words : Date of first authorisation
Removal of words : Date of latest renewal and date change from 24 February 2011
Section 10
Date change from 24 February 2011 to 13.07.11
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Updated on 23/06/2011 and displayed until 28/07/2011
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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 6. 5 - Nature and Contents of Container
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 24-Feb-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 2
Addition of: For excipients, see section 6.1.
Section 6.5
Deletion of duplicate paragraph: Packaging available in packs 30g and 50g.
Addition : Not all pack sizes may be marketed.
Section 9
Addition of: Date of first authorisation: 22 November 2004. Date of latest renewal: 24 February 2011.
Section 10
Date change from May 21 2008 to 24 February 2011.
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Updated on 04/08/2008 and displayed until 23/06/2011
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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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| Date of revision of text on the SPC: |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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