Summary of Product Characteristics
last updated on the eMC:
03/03/2010
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 03/03/2010 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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 16-Feb-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.8 – Undesirable effects
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Addition of pruritus, skin burning sensation, erythema pain at administration site, discomfort, swelling, hypersensitivity, angiodema, contact dermatitis, rash urticaria, blister, skin exfoliation
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Change to section 10 – Date of revision of the text
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Changed to 16 february 2010
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Updated on 18/09/2009 and displayed until 03/03/2010
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Reasons for adding or updating:
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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: 11-Sep-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.3 - Contraindications
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Addition of : Pevaryl Topical Cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.
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Change to section 10 – Date of revision of the text
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Changed to 11th September 2009
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Updated on 03/09/2009 and displayed until 18/09/2009
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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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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 6. 6 - Instructions for use, handling and disposal
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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-Aug-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 1 –Name of the medicinal product*
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Pevaryl 1% Topical cream
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Change to section 2 – quantitative and qualitative composition*
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Addition of excipient warnings
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Change to section 4.2 – Posology and |Method of Administration
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Changed from topical to cutaneous
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Change to section 6.6 – Instructions for use, handling and disposal*
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Standard disposal statement added
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Change to section 10 – Date of revision of the text
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Changed to August 2009
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Updated on 28/05/2009 and displayed until 03/09/2009
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Reasons for adding or updating:
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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: 18-Mar-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 9 – Date of Renewal of Authorisation
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18th March 2009
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Change to section 10 – Date of revision of the text
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18th March 2009
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Updated on 11/12/2008 and displayed until 28/05/2009
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 18-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 6.3 – Shelf Life
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Reduce shelf life form 36months to 24 months
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Change to section 10 – Date of revision of the text
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18th June 08
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Updated on 04/04/2008 and displayed until 11/12/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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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: 03/2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 7 - changed to 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Change to section 10 - changed to 28th March 2008
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Updated on 26/08/2004 and displayed until 04/04/2008
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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 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 8 - MA number
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Change to section 10 (date of (partial) revision of the text
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Updated on 30/08/2001 and displayed until 26/08/2004
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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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Updated on 29/08/2001 and displayed until 30/08/2001
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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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