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Substance and product data management services

The European Medicines Agency (EMA) is delivering a Product Management Service (PMS) and a Substance Management Service (SMS) to support regulatory activities in the European Union (EU).

Last updated: 12 June 2026
HumanData on medicines
Amlodipine / Valsartan Mylan
INN or common name:amlodipine; valsartan
Therapeutic area (MeSH):Hypertension
Marketing authorisation issued:
Last updated:12 June 2026
Revision: 18
Generic
MedicineHumanAuthorised
Fingolimod Mylan
INN or common name:fingolimod
Therapeutic area (MeSH):Multiple Sclerosis, Relapsing-Remitting
Marketing authorisation issued:
Last updated:12 June 2026
Revision: 10
Generic
MedicineHumanAuthorised
Deferasirox Mylan
INN or common name:deferasirox
Therapeutic area (MeSH):Iron Overload; beta-Thalassemia
Marketing authorisation issued:
Last updated:12 June 2026
Revision: 13
Generic
MedicineHumanAuthorised
Azacitidine Mylan
INN or common name:azacitidine
Therapeutic area (MeSH):Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Marketing authorisation issued:
Last updated:12 June 2026
Revision: 2
Generic
MedicineHumanAuthorised
Fubelv
INN or common name:etanercept
Therapeutic area (MeSH):Arthritis, Rheumatoid; Arthritis, Juvenile; Arthritis, Psoriatic; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis; Spondylitis, Ankylosing; Psoriasis
Marketing authorisation issued:
Last updated:12 June 2026
Revision: 1
Additional monitoring
Biosimilar
MedicineHumanAuthorised
Apremilast Accord
INN or common name:apremilast
Therapeutic area (MeSH):Arthritis, Psoriatic; Psoriasis; Behcet Syndrome; Oral Ulcer
Marketing authorisation issued:
Last updated:12 June 2026
Revision: 5
Generic
MedicineHumanAuthorised