Summary of Product Characteristics
last updated on the eMC:
27/04/2012
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 27/04/2012 and displayed until Current
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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 8 - MARKETING AUTHORISATION NUMBER(S)
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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-Apr-2012 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| section 7 & 8 updated to reflect change in MAH to Forest Laboratories UK Ltd
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Updated on 04/11/2010 and displayed until 27/04/2012
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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 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Sep-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 - Addition of new name - Veno's Expectorant
Section 4.3 - Addition of all contra-indications (previously none listed)
Section 4.4 - Addition of all warnings with the exception of 'Keep out of reach of children' and 'If sympoms persist consult a Dr' which appeared previously
Section 4.8 - Addition of all undesirable effects with the exception of GI discomfort which was listed previously
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Updated on 16/04/2009 and displayed until 04/11/2010
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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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| Date of revision of text on the SPC: |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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