BETAHISTINE GxP betahistine dihydrochloride 16 mg tablets blister packs
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
सार्वजनिक आकलन रिपोर्ट
(PAR)
26-11-2017
अनुरोध भेजा।
सक्रिय संघटक:
betahistine dihydrochloride, Quantity: 16 mg
थमां उपलब्ध:
Arrotex Pharmaceuticals Pty Ltd
INN (इंटरनेशनल नाम):
betahistine dihydrochloride
फार्मास्यूटिकल फॉर्म:
Tablet, uncoated
रचना:
Excipient Ingredients: purified talc; mannitol; microcrystalline cellulose; citric acid; colloidal anhydrous silica
प्रशासन का मार्ग:
Oral
पैकेज में यूनिट:
10 tablets, 30 tablets, 60 tablets, 100 tablets, 25 tablets
प्रिस्क्रिप्शन प्रकार:
(S4) Prescription Only Medicine
चिकित्सीय संकेत:
Meniere's Syndrome as defined by the following core symptoms: vertigo (with nausea/vomiting), hearing loss (hardness of hearing) and tinnitus.
उत्पाद समीक्षा:
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
प्राधिकरण का दर्जा:
Licence status A
प्राधिकरण की तारीख:
2014-08-14
