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.

Last updated:
HumanBiologicalsRegulatory and procedural guidanceResearch and developmentScientific guidelines
Veterinary limited markets

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) introduced a specific authorisation route for medicines intended for veterinary limited markets in the European Union (EU) when it became applicable on 28 January 2022.

Last updated:
VeterinaryVeterinary limited markets
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