Summary of Product Characteristics
last updated on the eMC:
08/05/2012
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 08/05/2012 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 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 20-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.1 - Therapeutic indications - clarification that Tredaptive is indicated for adults only has been added.
Section 4.2 - Posology and method of administration -A qualifying statement that safety and efficacy has not been established in patients under the age of 18 has been added.
Section 5.1 - Pharmacodynamic properties - Details of withdrawal study added
Section 5.2 - Pharamacokinetic properties - Information on Chinese patients added under the subsection headed race.
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Updated on 07/09/2011 and displayed until 08/05/2012
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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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| Date of revision of text on the SPC: 25-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.5 -Information on comcomitant use with acetylsalicylic acid and clopidogrel has been added, the wording is as follows:
'In a clinical study in dyslipidaemic patients receiving both acetylsalicylic acid (81 mg) and clopidogrel (75 mg), laropiprant induced transient (4 hours post-dose) inhibition of platelet function in vivo (as evaluated by bleeding time and platelet aggregation studies), but had little effect across the dosing interval.'
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Updated on 08/06/2011 and displayed until 07/09/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 23-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 - The additional side effect of vesicubullous rash has been added to the sub-section headed 'Post-marketing experience and other clinical trial experience'
Section 6.4 - The storage conditions now read 'Do not store above 30°C. Store in the original package in order to protect from light and moisture'. For both types of blisters.
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Updated on 20/01/2011 and displayed until 08/06/2011
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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 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 21-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - the paragraph on method of administration has been moved.
Section 4.6 - information from animal studies has been added.
Section 4.8 - the system organ class headings have been re-ordered. A new paragraph relating to post-marketing experience has been added and the additional side effect of anaphylactic shock is included under immune system disorders.
Section 5.1- statements are included stating that the EMA has waived the obligation to submit results of paediatric studies for specified indications
Section 5.3 - information on fertility from the DART studies has been added.
Section 6.3 - the shelf life in aluminium/aluminium blisters has been reduced to 18 months.
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Updated on 11/02/2010 and displayed until 20/01/2011
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 26-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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The following sections have changed:
Sections 4.2 and 4.5 - Added that eating spicy foods should be avoided at the time of ingestion of Tredaptive to reduce the possibility of flushing.
Section 4.4 - Added section detailing that a higher than expected incidence of myopathy has been seen in Chinese patients taking Tredaptive and 40mg simvastatin.
Section 5.1 - editorial change
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Updated on 16/09/2009 and displayed until 11/02/2010
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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 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 31-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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SPC changes are as follows:
Section 4.5: The following Information on patients concomitantly receiving laropiprant with acetylsalicylic acid and clopidogrel has been added:
Acetylsalicylic acid and clopidogrel: A clinical study to evaluate the effect of laropiprant on platelet function in patients concomitantly receiving both acetylsalicylic acid and clopidogel was inconclusive. Because this study did not rule out the potential for prolongation of bleeding time patients receiving Tredaptive concomitantly with acetylsalicylic acid and clopidogel should be closely monitored.
In addition all the registered pack sizes have been added to section 6.5.
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Updated on 03/09/2009 and displayed until 16/09/2009
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| 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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