SILUMBRA suvorexant 20mg tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
27-11-2017

有効成分:

suvorexant, Quantity: 20 mg

から入手可能:

Merck Sharp & Dohme (Australia) Pty Ltd

INN(国際名):

suvorexant

医薬品形態:

Tablet, film coated

構図:

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

投与経路:

Oral

パッケージ内のユニット:

30 tablets, 3 tablets, 10 tablets

処方タイプ:

(S4) Prescription Only Medicine

適応症:

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].

製品概要:

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

認証ステータス:

Registered

承認日:

2016-11-16