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

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

agomelatine, Quantity: 25 mg

Dostupno od:

Servier Laboratories (Aust) Pty Ltd

INN (International ime):

Agomelatine

Farmaceutski oblik:

Tablet, film coated

Sastav:

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

Administracija rute:

Oral

Jedinice u paketu:

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

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

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

Proizvod sažetak:

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

Status autorizacije:

Licence status A

Datum autorizacije:

2016-11-15