BETAHISTINE GxP betahistine dihydrochloride 16 mg tablets blister packs

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

betahistine dihydrochloride, Quantity: 16 mg

Disponibil de la:

Arrotex Pharmaceuticals Pty Ltd

INN (nume internaţional):

betahistine dihydrochloride

Forma farmaceutică:

Tablet, uncoated

Compoziție:

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

Calea de administrare:

Oral

Unități în pachet:

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

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

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

Rezumat produs:

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

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2014-08-14