Shortage of Ixiaro (Japanese encephalitis vaccine (inactivated, adsorbed))
Submitted by Anonymous (not verified) on 20 November 2024 - 14:08
Shortage of Ixiaro (Japanese encephalitis vaccine (inactivated, adsorbed))
Orphan designation: Atacicept Treatment of primary IgA nephropathy, 10/11/2024 Positive
Submitted by Anonymous (not verified) on 20 November 2024 - 13:54
Orphan designation: Atacicept Treatment of primary IgA nephropathy, 10/11/2024 Positive
Human medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Date of authorisation: 23/07/2012, Revision: 44, Status: Authorised
Submitted by Anonymous (not verified) on 20 November 2024 - 13:50
Human medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Date of authorisation: 23/07/2012, Revision: 44, Status: Authorised
Orphan designation: 3-(5-(2-Hydroxy-2-methylpropoxy)-6-methylpyrazin-2-yl)-1H-indole-7-carbonitrile Treatment of X-linked spinal and bulbar muscular atrophy (Kennedy's disease), 10/11/2024 Positive
Submitted by Anonymous (not verified) on 20 November 2024 - 13:33
Orphan designation: 3-(5-(2-Hydroxy-2-methylpropoxy)-6-methylpyrazin-2-yl)-1H-indole-7-carbonitrile Treatment of X-linked spinal and bulbar muscular atrophy (Kennedy's disease), 10/11/2024 Positive
Orphan designation: 4,9-Dimethyl-6-(4'-aminophenyl)-2H-furo[2,3-h]-1-benzopyran-2-one Treatment of cystic fibrosis, 10/11/2024 Positive
Submitted by Anonymous (not verified) on 20 November 2024 - 13:31
Orphan designation: 4,9-Dimethyl-6-(4'-aminophenyl)-2H-furo[2,3-h]-1-benzopyran-2-one Treatment of cystic fibrosis, 10/11/2024 Positive
Orphan designation: Interleukin-12, human, recombinant Treatment of cutaneous T-cell lymphoma, 10/11/2024 Positive
Submitted by Anonymous (not verified) on 20 November 2024 - 12:43
Orphan designation: Interleukin-12, human, recombinant Treatment of cutaneous T-cell lymphoma, 10/11/2024 Positive
Social Media Data for Real World Evidence in Regulatory Decision Making
Submitted by Anonymous (not verified) on 20 November 2024 - 12:40
Social Media Data for Real World Evidence in Regulatory Decision Making
Procurement
Submitted by Anonymous (not verified) on 20 November 2024 - 12:27
Procurement
CTIS newsflash - 19 November 2024
Submitted by Anonymous (not verified) on 20 November 2024 - 12:13
CTIS newsflash - 19 November 2024
Medical devices
Submitted by Anonymous (not verified) on 20 November 2024 - 12:09
Medical devices