Summary of Product Characteristics
last updated on the eMC:
26/03/2010
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 26/03/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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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: 05-Mar-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 6.5:
(1) To register an alternative child resistant cap for the currently approved amber glass bottles.
The proposed cap is a 2-piece plastic child-resistant cap with a tamper evident closure. The wad
material (polyvinylidene chloride (PVDC) faced wad) in contact with the finished product
remains unchanged.
(2) To register the removal from the licence of the following pack sizes/packaging: pack size - 30
ml; caps - metal roll on closures and plastic screw caps; wads fitted in caps - PVDC-lined wad
and polyethylene (PE)/expanded polyethylene laminated wad.
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Updated on 28/01/2010 and displayed until 26/03/2010
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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: 14-Jan-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Additional name registered on licence
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Updated on 02/07/2009 and displayed until 28/01/2010
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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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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| Date of revision of text on the SPC: 31-Mar-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update to Childrens Cough and Cold medicinal products as requested by the MHRA:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON038908
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Updated on 19/05/2008 and displayed until 02/07/2009
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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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| Date of revision of text on the SPC: 04-Apr-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update the SPC to add stronger warnings for children aged 2 – 6 years.
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Updated on 27/02/2008 and displayed until 19/05/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 02/2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7: Change of MA holder
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Updated on 20/03/2007 and displayed until 27/02/2008
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 11/2004 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 = added a word break
Section 5.1 = corrected a spelling
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Updated on 14/03/2007 and displayed until 20/03/2007
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Reasons for adding or updating:
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