DIMETHYL FUMARATE INTAS dimethyl fumarate 120 mg enteric coated capsule blister pack
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
सार्वजनिक आकलन रिपोर्ट
(PAR)
28-06-2022
अनुरोध भेजा।
सक्रिय संघटक:
dimethyl fumarate, Quantity: 120 mg
थमां उपलब्ध:
Accord Healthcare Pty Ltd
फार्मास्यूटिकल फॉर्म:
Capsule, enteric
रचना:
Excipient Ingredients: croscarmellose sodium; Gelatin; purified talc; magnesium stearate; iron oxide yellow; silicified microcrystalline cellulose; triethyl citrate; titanium dioxide; brilliant blue FCF; methacrylic acid copolymer; colloidal anhydrous silica; iron oxide black; methacrylic acid - ethyl acrylate copolymer (1:1); propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; potassium hydroxide
प्रशासन का मार्ग:
Oral
पैकेज में यूनिट:
7 capsules, 112 capsules, 14 capsules
प्रिस्क्रिप्शन प्रकार:
(S4) Prescription Only Medicine
चिकित्सीय संकेत:
Dimethyl fumarate enteric coated capsules are indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.
उत्पाद समीक्षा:
Visual Identification: Size 0 HGC green cap and white body, printed with HR1 in black ink on body containing white to off-white, round, biconvex enteric coated mini tablets; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
प्राधिकरण का दर्जा:
Registered
प्राधिकरण की तारीख:
2022-06-28
