Summary of Product Characteristics
last updated on the eMC:
27/03/2012
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 27/03/2012 and displayed until Current
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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 4.9 - Overdose
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| Date of revision of text on the SPC: 15-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4 – addition of information regarding hypoglycaemia
Section 4.8 – addition of information regarding neuropathic pain
Section 4.9 – supplemented with the potential for administering glucagon intravenously.
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Updated on 08/07/2011 and displayed until 27/03/2012
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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: 23-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4 updated - information regarding the use of Hypurin insulins with pioglitazone added.
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Updated on 22/03/2011 and displayed until 08/07/2011
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Reasons for adding or updating:
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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 4.5 - Interaction with other medicinal products 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 6.2 - Incompatibilities
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| Date of revision of text on the SPC: 27-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| SmPC changes to section 4.3, 4.4, 4.5, 4.6, 4.8, 4.9 and 6.2 clinical updates following PSUR.
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Updated on 08/09/2008 and displayed until 22/03/2011
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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-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 - 'CP Pharmaceuticals Ltd' amended to 'Wockhardt UK Ltd'
Section 8 - PL 04543/0366 amended to PL 29831/0127
Section 9 & 10 amended
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Updated on 29/09/2003 and displayed until 08/09/2008
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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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Updated on 04/09/2002 and displayed until 29/09/2003
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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