SILUMBRA suvorexant 15mg tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
27-11-2017

Aktivna sestavina:

suvorexant, Quantity: 15 mg

Dostopno od:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (mednarodno ime):

suvorexant

Farmacevtska oblika:

Tablet, film coated

Sestava:

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

Pot uporabe:

Oral

Enote v paketu:

3 tablets, 10 tablets, 30 tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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].

Povzetek izdelek:

Visual Identification: White, oval, biconvex, film coated tablet, marked with MSD logo and 325 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

Status dovoljenje:

Registered

Datum dovoljenje:

2016-11-16