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Provisional Approval (PA) The PA pathway is intended for promising new prescription medicines or new indications for such medicines, for seriously debilitating or life-threatening conditions, where preliminary clinical evidence shows a potential to address an unmet clinical need or significant improvement over existing therapies [24, 25]

Typically, side effects include: Injection site reactions (redness, mild discomfort) Headaches or mild fatigue during the adjustment period Water retention Low-grade nausea Prolonged use or excessive doses require further research, which is why the advice is to always speak to a medical professional