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Your claim would seek reimbursement for medical expenses related to the side effects, lost income, and pain and suffering, regardless of initial drug coverage

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Reconstitution and Solution Stability Research indicates that reconstituted solutions maintain stability for approximately 3+ weeks when stored at 4C, and studies suggest extended stability of 3-4 months when frozen at -20C

Apart from the standard pharmacovigilance and RMP update requirements, the TGA uses an enhanced post-market monitoring and compliance framework, and prioritises provisionally approved medicines for post-market surveillance activities