Summary of Product Characteristics
last updated on the eMC:
27/10/2011
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 27/10/2011 and displayed until Current
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Sep-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Changes to Valdoxan SPC:
- Section 7 (Marketing Authorisation Holder)
Change of address of Les Laboratoires Servier:
50, rue Carnot
92284 Suresnes cedex
France
- Section 10 (Date of revision of the text)
09/2011
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Updated on 04/08/2011 and displayed until 27/10/2011
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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 revision of the text
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| Date of revision of text on the SPC: 01-Jul-2011 |
| 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…)
– Added:
- Caution in patients with a history of bipolar disorder
- Caution should be exercised when Valdoxan is administered to patients with pretreatment elevated transaminases (> the upper limit of the normal ranges and £3 times the upper limit of the normal range), preferably by laboratory tests within the first 3 weeks of treatment.
– Reworded:
- Caution should be exercised when prescribing Valdoxan for patients with hepatic injury risk factors e.g. obesity/overweight/non-alcoholic fatty liver disease, substantial alcohol intake or concomitant medicinal products associated with risk of hepatic injury.
Section 4.8 (Undesirable effects)
- Added: aggression, nightmares, abnormal dreams
Frequency not known
- Added: abdominal pain
Frequency not known
Section 10 (Date of revision of the text): 07/2011
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Updated on 02/02/2011 and displayed until 04/08/2011
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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 4.6 - 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 revision of the text
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| Date of revision of text on the SPC: 04-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Changes to Valdoxan SPC
Section 4.4 (Special warnings…) – Added:
- See section 4.8 (Mania/Hypomania)
- Caution should be exercised when Valdoxan is administered to patients with obesity/overweight/non-alcoholic fatty liver disease
Section 4.6 (Fertility…) – Reformatting of the section Fertility
Section 4.8 (Undesirable effects)
- Added: Mania/hypomania. These symptoms may also be due to the underlying disease (see section 4.4), Frequency not known
- Reformatting + Added: Agitation and related symptoms (as irritability and restlessness)
Frequency not known
- Added:
Frequency not known: pruritus
Section 4.9 (Overdose) - Rewording + Added: Experience with agomelatine in overdose (dose up to 2500 mg) has indicated that epigastralgia, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise have been reported.
One person having ingested 2450 mg agomelatine, recovered spontaneously without cardiovascular and biological abnormalities.
Section 10 (Date of revision of the text): January 2011
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Updated on 09/09/2010 and displayed until 02/02/2011
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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 4.4 - 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 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Aug-2010 |
| 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) - Added: Valdoxan is indicated in adults.
Section 4.2 (Posology…) - Rewording: Paediatric population The safety and efficacy of Valdoxan in children aged below 18 years have not been established. No data are available.
Section 4.4 (Special warnings…) - Rewording: Use in paediatric population
Section 4.5 (Interaction…) - Added: Paediatric population Interaction studies have only been performed in adults.
Section 4.6 (Fertility…) - Added: Fertility Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility, embryofoetal development and pre- and post natal development. (see section 5.3).
Section 4.8 (Undesirable effects) - Reformatting + Added: agitation (post-marketing experience) Frequency not known.
Section 4.9 (Overdose) - Rewording + Added: Experience with agomelatine in overdose (dose up to 2500mg) has indicated limited signs and symptoms including drowsiness and epigastralgia. Patients have recovered spontaneously without cardiovascular and biological abnormalities.
Section 10 (Date of revision of the text): August 2010
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Updated on 10/06/2009 and displayed until 09/09/2010
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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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