BETAHISTINE GxP betahistine dihydrochloride 16 mg tablets blister packs

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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공공 평가 보고서 공공 평가 보고서 (PAR)
26-11-2017

유효 성분:

betahistine dihydrochloride, Quantity: 16 mg

제공처:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

betahistine dihydrochloride

약제 형태:

Tablet, uncoated

구성:

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

관리 경로:

Oral

패키지 단위:

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

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

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

제품 요약:

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

승인 상태:

Licence status A

승인 날짜:

2014-08-14