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 3 - Pharmaceutical form
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Change to section 4.2 - Posology and method of administration
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Individual SPC superseded by joint SPC covering several presentations
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Change to section 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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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: 27-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| SPC updated to include licence for Inovelon Oral Suspension. All relevant sections updated to include information relating to this formulation.
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Updated on 25/01/2012 and displayed until 02/04/2012
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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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Change to section 10 date of revision of the text
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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: 09-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| The following text has been added to section 4.4:
Suicidal ideation
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. A meta-analysis of randomised placebo-controlled trials of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Inovelon.
Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Dates have been updated in section 9 and 10
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Updated on 15/12/2011 and displayed until 25/01/2012
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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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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 21-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Removal of interactions from section 4.5 - carbamazepine, phenobarbital, phenytoin, vigabatrin and primidone
Update of date of revision of text
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Updated on 15/12/2009 and displayed until 15/12/2011
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Reasons for adding or updating:
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SPC Submitted in error
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Change to section 6. 3 - Shelf Life
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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: 23-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 6.3
Shelf life changed from 3 years to 4 years
Date of revision of text updated to: 23rd October 2009
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Updated on 31/03/2009 and displayed until 15/12/2009
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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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Change to MA holder contact details
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| Date of revision of text on the SPC: 10-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 7
Updated address address details for MA Holder to: Eisai Limited, European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, UK
Section 10
Updated date of preparation to 10th March 2009
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Updated on 10/06/2008 and displayed until 31/03/2009
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 08-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| 4.2 Posology and method of administration
Patients <30 kg also receiving valproate medication:
Change to maximum recommended daily dose of Inovelon in patients <30 kg also receiving valproate medication:
Patients <30 kg also receiving valproate medication:
Treatment should be initiated at a daily dose of 200 mg. According to clinical response and tolerability, after a minimum of 2 days the dose may be increased by 200 mg/day, to the maximum recommended dose of 600 mg/day.
10. DATE OF REVISION OF THE TEXT
The date of revision of text has been updated:
08 April 2008
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Updated on 25/02/2008 and displayed until 10/06/2008
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4 - Special warnings and precautions for use
The statement below has been added to this section
In a thorough QT study, rufinamide produced a decrease in QTc interval proportional to concentration. Although the underlying mechanism and safety relevance of this finding is not known, clinicians should use clinical judgment when assessing whether to prescribe rufinamide to patients at risk from further shortening their QTc duration (eg. Congenital Short QT Syndrome or patients with a family history of such a syndrome).
Section 10: Date of revision of the text
This has changed to the 23rd August 2007
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Updated on 25/09/2007 and displayed until 25/02/2008
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Reasons for adding or updating:
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