Summary of Product Characteristics
last updated on the eMC:
03/11/2009
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 03/11/2009 and displayed until Current
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Reasons for adding or updating:
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Change to separate SPCs covering individual presentations
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| Date of revision of text on the SPC: 05-Dec-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| SmPC separated for Aquadrate and Hydromol Intensive
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Updated on 06/04/2009 and displayed until 03/11/2009
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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: 05-Dec-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1- The folllowing text has been added:
Hydromol Intensive
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Updated on 25/05/2006 and displayed until 06/04/2009
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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 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 10/05/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 the name of the product has changed from Aquadrate Cream to Aquadrate 10% w/w Cream.
Section 4.8 (undesirable effects) local irritations (including erythema, burning or pruritus) [when applied to sensitive, moist or fissured skin] have been added and stinging has been removed.
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Updated on 01/04/2005 and displayed until 25/05/2006
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change from the BAN of the active substance to the rINN
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Updated on 01/04/2005 and displayed until 01/04/2005
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change from the BAN of the active substance to the rINN
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Updated on 17/05/2002 and displayed until 01/04/2005
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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