Summary of Product Characteristics
last updated on the eMC:
30/07/2007
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 30/07/2007 and displayed until Current
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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 4.1 - Therapeutic indications
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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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: 06/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 2 Change of active name from Pramoxine to Pramocaine
Section 4.1 Change of active name from Pramoxine to Pramocaine
Section 4.9 Change of active name from Pramoxine to Pramocaine
Section 5.1 Change of active name from Pramoxine to Pramocaine
Section 10 Update to date of revision of text
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Updated on 13/12/2006 and displayed until 30/07/2007
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Reasons for adding or updating:
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Change of Marketing Authorisation Holder
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| Date of revision of text on the SPC: 06/2003 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change of Marketing Authorisation Holder
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Updated on 27/09/2006 and displayed until 13/12/2006
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Reasons for adding or updating:
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Change of Marketing Authorisation Holder
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| Date of revision of text on the SPC: 10/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change of Marketing Authorisation Holder
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Updated on 18/09/2003 and displayed until 27/09/2006
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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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