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Tolvaptan product-specific bioequivalence guidance
Opinion/decision on a Paediatric investigation plan (PIP): Quviviq, Daridorexant...
Opinion/decision on a Paediatric investigation plan (PIP): Edarbi, Azilsartan me...
Rules of procedure for the Patients and Consumers Working Party (PCWP) and the H...
Mandate, objectives and composition of the Patients and Consumers Working Party ...
Mandate, objectives and composition of the Healthcare Professionals Working Part...
Fourth listen-and-learn focus group meeting of the Quality Innovation Group, Onl...
IRIS guide to registration and RPIs
Human medicines European public assessment report (EPAR): Bortezomib Accord, bor...
Human medicines European public assessment report (EPAR): Slenyto, melatonin, Da...
Opinion/decision on a Paediatric investigation plan (PIP): Sarclisa, Isatuximab,...
Human medicines European public assessment report (EPAR): Glyxambi, empagliflozi...
Human medicines European public assessment report (EPAR): Dupixent, dupilumab, D...
Human medicines European public assessment report (EPAR): Zubsolv, buprenorphine...
Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influ...
Reflection paper on a tailored clinical approach in biosimilar development
Human medicines European public assessment report (EPAR): Evista, raloxifene, Da...