Summary of Product Characteristics
last updated on the eMC:
07/10/2011
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 07/10/2011 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 4.6 - Pregnancy and Lactation
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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: 01-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Updates to sections 2 (Qualitative and Quantitative Composition, 4.6 (Fertility,
Pregnancy and Lactation); 6.6 and 10 (Date of revision of text).
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Updated on 04/08/2009 and displayed until 07/10/2011
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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: 01-Jun-2007 |
| Legal Category: POM |
| 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 27/07/2007 and displayed until 04/08/2009
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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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 4.9 spelling mistake for methylthioninium chloride
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Updated on 03/07/2007 and displayed until 27/07/2007
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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 and change of excipient name from BAN’s 'Methylene Blue ' to INN 'Methylithionium Chloride
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 26/09/2006 and displayed until 03/07/2007
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Pending awaiting re-submission
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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 to section 6. 3 - Shelf Life
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Updated on 18/09/2003 and displayed until 26/09/2006
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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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