ARDIX AGOMELATINE agomelatine 25 mg film-coated tablet blister pack.

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

agomelatine, Quantity: 25 mg

Tilgængelig fra:

Servier Laboratories (Aust) Pty Ltd

INN (International Name):

Agomelatine

Lægemiddelform:

Tablet, film coated

Sammensætning:

Excipient Ingredients: magnesium stearate; povidone; stearic acid; colloidal anhydrous silica; sodium starch glycollate type A; maize starch; lactose monohydrate; propylene glycol; butan-1-ol; ethanol; isopropyl alcohol; Shellac; strong ammonia solution; indigo carmine aluminium lake; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; glycerol

Indgivelsesvej:

Oral

Enheder i pakken:

28 tablets (commercial pack), 56 tablets, 7 tablets (medical sample)

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Treatment in adults of: - of major depression (MDD) including prevention of relapse - generalised anxiety disorder (GAD)

Produkt oversigt:

Visual Identification: Orange-yellow, oblong film-coated tablet with blue imprint of Servier logo on one face; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Autorisation status:

Licence status A

Autorisation dato:

2016-11-15