PRIME: priority medicines

PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach...

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HumanEarly accessRegulatory and procedural guidanceResearch and development
Trazimera
trastuzumab
Stomach Neoplasms
Breast Neoplasms
Date of authorisation:
Revision: 12
Last updated:
MedicineHumanAuthorised
Hefiya
adalimumab
Spondylitis, Ankylosing
Hidradenitis Suppurativa
Psoriasis
Arthritis, Juvenile Rheumatoid
Uveitis
Date of authorisation:
Revision: 15
Last updated:
MedicineHumanAuthorised
Biologicals: finished product

The European Medicines Agency's scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.

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HumanBiologicalsRegulatory and procedural guidanceResearch and developmentScientific guidelines
Semglee
insulin glargine
Diabetes Mellitus
Date of authorisation:
Revision: 10
Last updated:
MedicineHumanAuthorised
Kanjinti
trastuzumab
Stomach Neoplasms
Breast Neoplasms
Date of authorisation:
Revision: 10
Last updated:
MedicineHumanAuthorised