BETAHISTINE GxP betahistine dihydrochloride 16 mg tablets blister packs

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

betahistine dihydrochloride, Quantity: 16 mg

MAH:

Arrotex Pharmaceuticals Pty Ltd

INN:

betahistine dihydrochloride

pharmaceutical_form:

Tablet, uncoated

composition:

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

administration_route:

Oral

units_in_package:

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

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

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

leaflet_short:

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

authorization_status:

Licence status A

authorization_date:

2014-08-14