Summary of Product Characteristics
last updated on the eMC:
17/11/2010
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 17/11/2010 and displayed until Current
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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 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 08-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.2 Posology and method of administration
Children and adolescents under the age of 18 years
Remeron should not be used in children and adolescents under the age of 18 years as efficacy was not demonstrated in two short-term clinical trials (see section 5.1) and because of safety concerns (see sections 4.4, 4.8 and 5.1).
4.8 Undesirable effects
Paediatric population:
The following adverse events were observed commonly in clinical trials in children: weight gain, urticaria and hypertriglyceridaemia (see also section 5.1).
5.1 Pharmacodynamic properties
Paediatric population:
Two randomised, double-blind, placebo-controlled trials in children aged between 7 and 18 years with major depressive disorder (n=259) using a flexible dose for the first 4 weeks (15-45mg mirtazapine) followed by a fixed dose (15, 30 or 45 mg mirtazapine) for another 4 weeks failed to demonstrate significant differences between mirtazapine and placebo on the primary and all secondary endpoints. Significant weight gain (≥7%) was observed in 48.8% of the Remeron treated subjects compared to 5.7% in the placebo arm. Urticaria (11.8% vs 6.8%) and hypertriglyceridaemia (2.9% vs 0%) were also commonly observed.
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Updated on 26/08/2010 and displayed until 17/11/2010
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 01-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.6 - Pregnancy and lactation:
· To include epidemiological data and the use of SSRI's and other serotonergic antidepressants (e.g. mirtazapine) related to the risk of developing Persistent Pulmonary Hypertension in the newborn in pregnancy issued by the PhVWP and CMD(h) (March 2010).
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Updated on 06/07/2010 and displayed until 26/08/2010
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 22-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| · The order of System Organ Class (SOC) in table 1. Adverse reactions of Mirtazapine
has been brought in line with the EU Guideline on SPCs (SEP 2009).
· Available data justify removal of “Inappropriate antidiuretic hormone secretion” from the
Adverse Events, so in line with the deletion of the adverse event the SOC Endocrine
disorders has also been deleted.
· Based on the evaluation, the company decided to include relevant preferred terms
related to severe skin reactions. Since no cases were found in the clinical trial
database, the AE is listed under 'frequency not known'.
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Updated on 24/03/2009 and displayed until 06/07/2010
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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