The Drugs Controller General (India) has directed the State drug controllers to restrict the fixed dose combination (FDC) tolperisone HCI 150 mg+ paracetamol IP 500 mg tablet only for symptomatic treatment of post-stroke spasticity associated with pain in adults, and direct the manufacturers to submit phase IV clinical trial data on revised indication
Tolperisone FDC Usage Only To Post Stroke Spastici | 04/09/2021 | By Darshana | 428
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