Transcription of Naproxen Sodium - Medsafe
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Naproxen Sodium - Medsafe
Rescheduling Application for Naproxen Sodium 275 mg Solid Dose Forms (Naprogesic ). From Pharmacy Medicine to General Sales Medicine January 2013. Naprogesic Rescheduling Application January 2013. INDEX. Page EXECUTIVE SUMMARY 2. PART A 7. A1. Name of the Medicine 7. A2. Name of the Company 8. A3. Dose Forms, Strengths and Pack Sizes 8. A4. Indications 8. A5. Classification 12. A6. Extent of Usage 21. A7. Labelling 23. A8. Proposed Warnings 26. A9. Other Products 36. PART B 1. Benefits of the Proposed Change 2. Relevant Comparative Data for Like Compounds 6. Ibuprofen 6. Diclofenac 10. Paracetamol 11. APPENDICES. REFERENCES. -1- Naprogesic Rescheduling Application January 2013. EXECUTIVE SUMMARY. This submission to the New Zealand Medicines Classification Committee seeks rescheduling of Naproxen Sodium 275 mg oral solid dose forms from the current classification of Pharmacy Medicine to General Sales Medicine.
Naprogesic Rescheduling Application January 2013 - 5 - exposure) support the Bayer company assessment that “the benefit-risk balance for naproxen sodium remains favourable”.
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