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Orphan designation: Acetylleucine Treatment of ataxia-oculomotor apraxia, 16/04/2024 Positive
Human medicines European public assessment report (EPAR): Prezista, darunavir, Date of authorisation: 11/02/2007, Revision: 55, Status: Authorised
Paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350 and 525 mg product-specific bioequivalence guidance
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Maximum residue limits (MRL)
Questions and answers on standard animal weights for estimating worst-case consumer exposure scenarios