SILUMBRA suvorexant 20mg tablet blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

suvorexant, Quantity: 20 mg

Tilgængelig fra:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

suvorexant

Lægemiddelform:

Tablet, film coated

Sammensætning:

Excipient Ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; copovidone; croscarmellose sodium; titanium dioxide; hypromellose; triacetin

Indgivelsesvej:

Oral

Enheder i pakken:

30 tablets, 3 tablets, 10 tablets

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

SILUMBRA is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. Following initiation of treatment, continuation should be re-evaluated after 3 months [see Pharmacodynamic Properties, Clinical trials and Adverse Effects (Undesirable Effects) for clinical trial durations].

Produkt oversigt:

Visual Identification: White, round, biconvex, film coated tablet, marked with MSD logo and 335 on one side, and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorisation status:

Registered

Autorisation dato:

2016-11-16