Template for scientific document for paediatric investigation plan or product-specific waiver

Procedural advice on paediatric applications

Human medicines European public assessment report (EPAR): Voriconazole Accord, voriconazole, Date of authorisation: 16/05/2013, Revision: 21, Status: Authorised

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Human medicines European public assessment report (EPAR): Vildagliptin / Metformin hydrochloride Accord, vildagliptin,metformin hydrochloride, Date of authorisation: 24/03/2022, Revision: 4, Status: Authorised

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ICH Guideline M13B on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Scientific guideline