Summary of Product Characteristics
last updated on the eMC:
25/03/2011
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 25/03/2011 and displayed until Current
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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 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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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 23-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes to sections 4.2, 4.3., 4.4., 4.8., and 5.2. of SPC following implementation of changes requested by the MHRA following European paediatric work-sharing procedure
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Updated on 04/05/2010 and displayed until 25/03/2011
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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 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 22-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change in name of medicinal product - section 1 and reformatting of section 4.2.
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Updated on 27/08/2009 and displayed until 04/05/2010
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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: 19-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to Section 7. Marketing Authorisation Holder
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Updated on 21/10/2008 and displayed until 27/08/2009
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Reasons for adding or updating:
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Change to manufacturer contact details
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| Date of revision of text on the SPC: 01-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change of manufacturing site
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Updated on 15/01/2008 and displayed until 21/10/2008
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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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Change to section 4.8 - Undesirable Effects
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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: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| section 7: MA holder changed to
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU
UK
section 8: Product Licence changed to PL 19166/0045
section 10: changed to October 2007.
section 4.4: ''Patients who experience visual disturbance should be withdrawn from treatment'' has been added from section 4.8.
section 4.8: ''Patients who experience visual disturbance should be withdrawn from treatment'' has been removed from this section and placed in section 4.4
section 4.8: ''There have been rare cases of retinal/artery occlusion reported'' has been added.
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Updated on 26/09/2007 and displayed until 15/01/2008
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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: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Marketing Authorisation Holder address changed from:
Regus House
Herald Way
Pegasus Business Park
Castle Donington Derbyshire
DE74 2TZ
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU
The PL number changed from PL 19477/0016 to PL 19166/0045
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Updated on 16/08/2005 and displayed until 26/09/2007
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Reasons for adding or updating:
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