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Introduction to Product Submission Submission Details Type of Submission New Chemical Entity Decision: Approved Date of Decision: tapentadol 24 December 2010 Active ingredient(s): Tapentadol (as hydrochloride) Product Name(s): Palexia SR (sustained release) Sponsor’s Name and 45 Poplar Rd, Parkville, VIC 3052 Dose form(s): Tablets Strength(s): 50, 100, 150, 200 & 250 mg Container(s): PVC/PVDC – Al/PET/paper blister packs Pack size(s): 7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 90 & 100 Approved Therapeutic use: For the management of moderate to severe chronic pain unresponsive to non-narcotic analgesia .
There is currently no clinical trial data available nucynta j code tapentadol compared to morphine tapentadol urine drug testing nucynta j code regarding the safety and efficacy of Palexia SR in patients with pain due to malignancy .

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