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CENTER FOR DRUG EVALUATION AND RESEARCHAPPLICATION NUMBER:202788Orig1s000REMSInitial REMS Approval: 1/2012PROPOSED TRANSMUCOSAL IMMEDIATE RELEASE (TIRE) RISK EVALUATION AND MITIGATION STRATEGY (REMS)Page
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The proposed transmucosal immediate release is a method of delivering medication through the mucous membranes for immediate absorption into the bloodstream.
Any pharmaceutical company or drug manufacturer planning to release a transmucosal immediate release product must file the proposal.
The proposed transmucosal immediate release form must be completed with detailed information about the medication, its intended use, and the method of delivery.
The purpose of proposed transmucosal immediate release is to ensure the safe and effective delivery of medication through the mucous membranes.
The proposed transmucosal immediate release must include information about the drug's formulation, intended use, dosage, and any potential side effects.
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