Summary of Product Characteristics
last updated on the eMC:
28/07/2011
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 28/07/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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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: 18-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The key changes to the SmPC are:
Section 4.6 (Pregnancy & Lactation) has been updated to bring it into line with the CCDS text.
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Updated on 13/05/2011 and displayed until 28/07/2011
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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 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: 08-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The key changes are:
Section 2: ‘Qualitative and Quantitative Composition’ of the SmPC has been updated to reflect current standard terminology in line with the European Guideline on the Summary of Product Characteristics. There is a consequential change to section 4.4 with the addition of a 'Lactose and Sucrose Intolerance' warning; in line with the guidance in Notice to Applicants: ENTR/F2/BL D (2003).
Section 6.6
has been updated in line with EC Guideline and now states 'No special requirements'
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Updated on 02/02/2010 and displayed until 13/05/2011
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 25-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The key changes to the SmPC are:
- The MHRA have updated their version on RamaXL to remove discrepancies found post 'Change of Ownership'.
- The date of revision of the text has been amended to 25th January 2010.
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Updated on 27/06/2008 and displayed until 02/02/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 01-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| All updates are due to change of ownership, from Schering Healthcare Ltd to Bayer Plc effective from 1 May 2008.
Section 7: MAH now Bayer plc
Section 8: Licence number is now PL 00010/ 0546
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008
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Updated on 09/01/2002 and displayed until 27/06/2008
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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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Updated on 31/07/2001 and displayed until 09/01/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/2000 and displayed until 31/07/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 06/09/2000
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