SILUMBRA suvorexant 15mg tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

suvorexant, Quantity: 15 mg

Disponível em:

Merck Sharp & Dohme (Australia) Pty Ltd

DCI (Denominação Comum Internacional):

suvorexant

Forma farmacêutica:

Tablet, film coated

Composição:

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

Via de administração:

Oral

Unidades em pacote:

3 tablets, 10 tablets, 30 tablets

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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].

Resumo do produto:

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 de autorização:

Registered

Data de autorização:

2016-11-16