Summary of Product Characteristics
last updated on the eMC:
02/04/2012
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 02/04/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 01-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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6.4. Special Precautions for Storage
6.5. Nature and Contents of Container
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Updated on 24/09/2008 and displayed until 02/04/2012
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8 of the SPC updated to include anaphylactic reaction as requested by the MHRA
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Updated on 10/08/2007 and displayed until 24/09/2008
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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 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.5 –sulphinpyrazone to sulfinpyrazone
7 –Milton Keynes address to Sandwich address
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Updated on 01/11/2004 and displayed until 10/08/2007
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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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Updated on 05/06/2003 and displayed until 01/11/2004
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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 10 (date of (partial) revision of the text
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Updated on 24/09/2002 and displayed until 05/06/2003
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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 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 11/06/2002 and displayed until 24/09/2002
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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 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/01/2002 and displayed until 11/06/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 31/07/2001 and displayed until 24/01/2002
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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