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At the same time, the Council retained the Commissions concept of a global MA, so that marketing authorisation holders with more than one product based on the same active substance, but for different orphan indications, would no longer be eligible for separate orphan market exclusivities
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The Phase 2 trial used 2mg as the starting dose, and it is the lowest dose in the standard published titration: 2mg, then 4mg, then 8mg, then 12mg, each held for 4 weeks
Understanding these mechanisms is not academic
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