Summary of Product Characteristics
last updated on the eMC:
02/11/2011
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 02/11/2011 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 4.3 - Contraindications
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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: 26-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2
Deletion of paragraph:
Children: Voltarol Emulgel is not recommended for use in children as dosage recommendations and indications for use in this group of patients have not been established.
Addition of paragraph:
Children and adolescents: 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 adolescents aged less than 14 years is contraindicated.
Section 10
Change of date from 24 January 2007 to 26 October 2011
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Updated on 28/09/2007 and displayed until 02/11/2011
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Reasons for adding or updating:
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Correction of spelling/typing errors
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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: 01/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| section 10 : revision date updated from August 2006 to 24 January 2007
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Updated on 17/08/2007 and displayed until 28/09/2007
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Reasons for adding or updating:
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