Summary of Product Characteristics
last updated on the eMC:
15/02/2012
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 15/02/2012 and displayed until Current
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Reasons for adding or updating:
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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 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 08-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| To update sections 4.1, 4.2, 4.6, 4.7, 4.8, 5.1, 5.2 and 6.6 of the SmPC to implement the Guideline on Summary of Product Characteristics Revision 2 of September 2009 and the corresponding QRD template Revision 5 of April 2010. Consequentially the leaflet has been updated.
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Updated on 18/10/2011 and displayed until 15/02/2012
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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 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 12-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Various changes to the notified sections following a renewal procedure. Please refer to document.
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Updated on 06/01/2010 and displayed until 18/10/2011
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 25-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 14/12/2009 and displayed until 06/01/2010
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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 4.2 - 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 4.6 - Pregnancy and Lactation
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 25-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 2 (Qualitative and Quantitative Composition): Information on lactose content added
Setion 4.2 (Posology and method of administration): Revised information - hepatic impairment
Section 4.3 (Contraindications): Deletion of 'lactation'
Section 4.4 (Special warnings and precautions for use): Revised information - hepatic imairment; pregnancy
Section 4.6 (Pregnancy and lactation): Revised information in line with PhVWP wording
Section 4,8 (Undesirable effects): Updated in line with post-marketing data; revised format
Section 5.2 (Pharmacokinetic properties): Statement on hepatic impairment revised
Section 10 (Date of revision of text): Updated to 25 October 2009
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Updated on 14/11/2006 and displayed until 14/12/2009
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Reasons for adding or updating:
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Company name change or merger
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| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 7 Marketing Authorisation Holder - Updated from Sankyo Pharma UK Ltd to Daiichi Sankyo UK Ltd; Change of Address
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Updated on 07/11/2006 and displayed until 14/11/2006
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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 4.4 - 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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Pending awaiting re-submission
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| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 Dosage statement regarding the Elderly has been amended. Renal impairment - additional cross-reference to Section 4.4.
Section 4.4 Addition of statement regarding lactose.
Section 4.8 Additional information on special populations: 'In elderly patients the frequency of hypotension is slightly increased from rare to uncommon.'
Section 5.2 Additional statement regarding the Elderly.
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Updated on 26/09/2006 and displayed until 07/11/2006
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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: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| 7. Marketing Authorisation Holder has been changed from Sankyo Pharma UK Ltd to Daiichi Sankyo UK Ltd; new Company Address.
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Updated on 06/06/2006 and displayed until 26/09/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 26/04/2006 and displayed until 06/06/2006
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Reasons for adding or updating:
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