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· If approved for marketing in Australia, an agreed RMP for tapendatol should be provided to nucynta the TGA prior to its entry onto the ARTG and that this should adhere to the EU RMP template with particular attention to the following: · Evaluation of the need for additional risk minimisation activities and justification of the lack · Presentation of details of important identified and potential risks in accordance with 1 . 2 of the template and the risk minimisation plan as tapentadol qt tapentadol dosage erowid tapentadol news tapentadol vs tramadol nucynta restless legs per section 4 of the template; and · Provision of adequate information in the template Annexes .
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Overall Conclusion and Risk/Benefit Assessment The submission was summarised in the following Delegate’s overview and recommendations: AusPAR Palexia SR Tapentadol CSL Ltd PM-2009-02489-3-1 Final 28 February 2011 Page 99 of 126 There are no objections in respect of Chemistry, Manufacturing and Controls to registration of tapentadol SR tablets, however the retest period applied to the API should be restricted to 30 tapentadol chemical structure tapentadol online cheap tapentadol cheap car tapentadol lekarstwo months rather than the 36 months proposed by the company .

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