Opinion/decision on a Paediatric investigation plan (PIP): Efruxifermin, decision type: , therapeutic area: , PIP number: P/0302/2022
Opinion/decision on a Paediatric investigation plan (PIP): 2’-O-(2’-methoxyethyl) modified antisense oligonucleotide targeting prekallikrein mRNA (ISIS 721744), decision type: , therapeutic area: , PIP number: P/0274/2022
Opinion/decision on a Paediatric investigation plan (PIP): 3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-2H-imidazo[4,5-c]pyridine-2-one (JNJ-53718678), decision type: , therapeutic area: , PIP number: P/0030/2021
Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human monoclonal antibody to GM-CSF (GSK3196165), decision type: , therapeutic area: , PIP number: P/0266/2020
Human medicines European public assessment report (EPAR): Kanuma, sebelipase alfa, Lipid Metabolism, Inborn Errors, Date of authorisation: 28/08/2015, Revision: 10, Status: Authorised
Human medicines European public assessment report (EPAR): Xultophy, insulin degludec,liraglutide, Diabetes Mellitus, Type 2, Date of authorisation: 18/09/2014, Revision: 16, Status: Authorised
Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Osteoporosis, Postmenopausal;Osteoporosis, Date of authorisation: 12/12/2022, Revision: 2, Status: Authorised
Human medicines European public assessment report (EPAR): Arava, leflunomide, Arthritis, Rheumatoid;Arthritis, Psoriatic, Date of authorisation: 02/09/1999, Revision: 41, Status: Authorised
Opinion/decision on a Paediatric investigation plan (PIP): (1R,2R)-2-[4-(5-methyl-1H-pyrazol-3-yl) benzoyl]-N-(4-oxo-6,7-dihydro-5H-pyrazolo [1,5-a]pyrazin-3-yl)cyclohexanecarboxamide (AZD5718), decision type: , therapeutic area: , PIP number: P/0269/2022
Human medicines European public assessment report (EPAR): Duloxetine Mylan, duloxetine, Neuralgia;Diabetic Neuropathies;Depressive Disorder, Major;Anxiety Disorders, Date of authorisation: 19/06/2015, Revision: 18, Status: Authorised