BRINTELLIX
vortioxetine (Brintellix) , Loesung 20 mg/ml 沃替西汀口服液
Active Ingredient:
Manufacturer:
Date of Approval:
Active Ingredient: vortioxetine
Manufacturer: Takeda Pharmaceuticals and Lundbeck
Date of Approval: 30 September 2013
Indications:
Brintellix (vortioxetine) is a new drug approved by the FDA for the treatment of adults with major depressive disorder (MDD). Commonly referred to as depression, MDD is a mental disorder characterised by mood changes and other symptoms that interfere with a person’s ability to work, sleep, study, eat and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person’s lifetime, although some may experience a single occurrence.
Registratienummer: |
EU/1/13/891/001-007 |
Registratienaam: |
Brintellix 20 mg/ml druppels voor oraal gebruik, oplossing |
Afleverstatus: |
Uitsluitend recept |
Registratiedatum: |
18 december 2013 |
SmPC/Patiëntenbijsluiter: |
Beschikbaar via de EMA website. Vanuit de zoekfunctie "Search for medicines" (linksboven op de pagina) is het geneesmiddel te selecteren door de productnaam in te vullen. Alle informatie over het geneesmiddel, inclusief de bijbehorende productinformatie, de openbare beoordelingsrapporten en andere relevante informatie worden dan getoond.
Ga naar de EMA website |
Werkzame stof(fen) |
VORTIOXETINEHYDROBROMIDE |
SAMENSTELLING |
overeenkomend met |
VORTIOXETINE |
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|
Hulpstof(fen) |
ETHANOL 96 % |
85 mg/ml |
HYDROXYPROPYL-BETA-CYCLODEXTRINE |
WATER, GEZUIVERD |
|
BRINTELLIX - Tropfen zum Einnehmen, Loesung 20 mg/ml XL. - 092501 - LUNDBECK A/S, DK-VALBY
vortioxetine (Brintellix®)
Reference No. 1199
Publication date:
07/05/2014
Appraisal information
vortioxetine (Brintellix®) 5 mg film-coated tablet
vortioxetine (Brintellix®) 10 mg film-coated tablet
vortioxetine (Brintellix®) 15 mg film-coated tablet
vortioxetine (Brintellix®) 20 mg film-coated tablet
vortioxetine (Brintellix®) 20 mg/ml oral drops
Company: |
Lundbeck Ltd |
BNF category: |
Central nervous system |
NMG meeting date: |
Not scheduled |
AWMSG meeting date: |
Not scheduled |
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Submission Type: |
Nonsubmission |
Status: |
Not endorsed |
Advice No: |
Not available |
Ministerial ratification: |
07/05/2014 |
