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Tryngolza
INN or common name: olezarsen
Therapeutic area (MeSH): Hyperlipoproteinemia Type I
Marketing authorisation issued:
Last updated: 17 October 2025
Additional monitoring
Orphan
Medicine Human Authorised
Izamby
INN or common name: denosumab
Therapeutic area (MeSH): Bone Resorption; Osteoporosis; Osteoporosis, Postmenopausal
Marketing authorisation issued:
Last updated: 17 October 2025
Revision: 1
Additional monitoring
Biosimilar
Medicine Human Authorised
Mynzepli
INN or common name: aflibercept
Therapeutic area (MeSH): Wet Macular Degeneration; Macular Edema; Diabetes Complications; Retinal Vein Occlusion; Choroidal Neovascularization
Marketing authorisation issued:
Last updated: 17 October 2025
Additional monitoring
Biosimilar
Medicine Human Authorised
Skyrizi
INN or common name: risankizumab
Therapeutic area (MeSH): Psoriasis; Arthritis, Psoriatic
Marketing authorisation issued:
Last updated: 17 October 2025
Revision: 29
Medicine Human Authorised
Qoyvolma
INN or common name: ustekinumab
Therapeutic area (MeSH): Psoriasis; Arthritis, Psoriatic; Colitis, Ulcerative; Crohn Disease
Marketing authorisation issued:
Last updated: 17 October 2025
Revision: 2
Additional monitoring
Biosimilar
Medicine Human Authorised
Kavigale
INN or common name: sipavibart
Therapeutic area (MeSH): COVID-19 virus infection
Marketing authorisation issued:
Last updated: 17 October 2025
Revision: 2
Medicine Human Authorised
Otulfi
INN or common name: ustekinumab
Therapeutic area (MeSH): Crohn Disease; Colitis, Ulcerative
Marketing authorisation issued:
Last updated: 17 October 2025
Revision: 4
Additional monitoring
Biosimilar
Medicine Human Authorised
Sapropterin Dipharma
INN or common name: sapropterin
Therapeutic area (MeSH): Phenylketonurias
Marketing authorisation issued:
Last updated: 17 October 2025
Revision: 6
Generic
Medicine Human Authorised
Tecartus
INN or common name: brexucabtagene autoleucel
Therapeutic area (MeSH): Lymphoma, Mantle-Cell
Marketing authorisation issued:
Last updated: 17 October 2025
Revision: 14
Additional monitoring
Advanced therapy
Conditional approval
Orphan
PRIME: priority medicine
Medicine Human Authorised
EMEA-002475-PIP03-22-M01 - paediatric investigation plan
Active substance: spesolimab
Therapeutic area: Congenital, familial and genetic disorders
Pharmaceutical form(s): Solution for infusion, Solution for injection
Route(s) of administration: Intravenous use; Subcutaneous use
Decision number: P/0341/2024
Decision date: 13 September 2024
Decision type: PM: decision on the application for modification of an agreed PIP
Compliance check done: No
Last updated: 17 October 2025
PIP Human
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