SILUMBRA suvorexant 20mg tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

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Werkstoffen:

suvorexant, Quantity: 20 mg

Beschikbaar vanaf:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (Algemene Internationale Benaming):

suvorexant

farmaceutische vorm:

Tablet, film coated

Samenstelling:

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

Toedieningsweg:

Oral

Eenheden in pakket:

30 tablets, 3 tablets, 10 tablets

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

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].

Product samenvatting:

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

Autorisatie-status:

Registered

Autorisatie datum:

2016-11-16