BETAHISTINE GxP betahistine dihydrochloride 16 mg tablets blister packs

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

betahistine dihydrochloride, Quantity: 16 mg

Disponible depuis:

Arrotex Pharmaceuticals Pty Ltd

DCI (Dénomination commune internationale):

betahistine dihydrochloride

forme pharmaceutique:

Tablet, uncoated

Composition:

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

Mode d'administration:

Oral

Unités en paquet:

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

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

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

Descriptif du produit:

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

Statut de autorisation:

Licence status A

Date de l'autorisation:

2014-08-14