BETAHISTINE GxP betahistine dihydrochloride 16 mg tablets blister packs

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)
26-11-2017

有効成分:

betahistine dihydrochloride, Quantity: 16 mg

から入手可能:

Arrotex Pharmaceuticals Pty Ltd

INN(国際名):

betahistine dihydrochloride

医薬品形態:

Tablet, uncoated

構図:

Excipient Ingredients: purified talc; mannitol; microcrystalline cellulose; citric acid; colloidal anhydrous silica

投与経路:

Oral

パッケージ内のユニット:

10 tablets, 30 tablets, 60 tablets, 100 tablets, 25 tablets

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Meniere's Syndrome as defined by the following core symptoms: vertigo (with nausea/vomiting), hearing loss (hardness of hearing) and tinnitus.

製品概要:

Visual Identification: Uncoated, round, biconvex, white to light creamy tablets, with a groove on one surface.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

認証ステータス:

Licence status A

承認日:

2014-08-14