EMEA-000534-PIP03-17-M01
Submitted by Anonymous (not verified) on 25 June 2025 - 10:12
EMEA-000534-PIP03-17-M01
Human medicines European public assessment report (EPAR): Foclivia, pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), Date of authorisation: 18/10/2009, Revision: 14, Status: Authorised
Submitted by Anonymous (not verified) on 25 June 2025 - 10:06
Human medicines European public assessment report (EPAR): Foclivia, pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), Date of authorisation: 18/10/2009, Revision: 14, Status: Authorised
Orphan designation: Radiprodil Treatment of GRIN-related neurodevelopmental disorder, 22/05/2025 Positive
Submitted by Anonymous (not verified) on 25 June 2025 - 9:22
Orphan designation: Radiprodil Treatment of GRIN-related neurodevelopmental disorder, 22/05/2025 Positive
Orphan designation: Doxorubicin,Liposomal,Pegylated Treatment of soft-tissue sarcoma, 22/05/2025 Positive
Submitted by Anonymous (not verified) on 25 June 2025 - 9:18
Orphan designation: Doxorubicin,Liposomal,Pegylated Treatment of soft-tissue sarcoma, 22/05/2025 Positive
Orphan designation: Tranilast Treatment of idiopathic pulmonary fibrosis, 22/05/2025 Positive
Submitted by Anonymous (not verified) on 25 June 2025 - 9:13
Orphan designation: Tranilast Treatment of idiopathic pulmonary fibrosis, 22/05/2025 Positive
Orphan designation: florbetaben (18F) Diagnosis of ATTR amyloidosis, 22/05/2025 Positive
Submitted by Anonymous (not verified) on 25 June 2025 - 9:12
Orphan designation: florbetaben (18F) Diagnosis of ATTR amyloidosis, 22/05/2025 Positive
Orphan designation: Adeno-associated viral vector serotype 2i8 containing the human LAMP2 isoform B transgene Treatment of Danon disease, 22/05/2025 Positive
Submitted by Anonymous (not verified) on 24 June 2025 - 18:20
Orphan designation: Adeno-associated viral vector serotype 2i8 containing the human LAMP2 isoform B transgene Treatment of Danon disease, 22/05/2025 Positive
Orphan designation: Equine polyclonal immunoglobulin F(ab')2 fragments against ricin Treatment of ricin poisoning, 22/05/2025 Positive
Submitted by Anonymous (not verified) on 24 June 2025 - 18:12
Orphan designation: Equine polyclonal immunoglobulin F(ab')2 fragments against ricin Treatment of ricin poisoning, 22/05/2025 Positive
Orphan designation: Tertomotide Treatment of progressive supranuclear palsy, 22/05/2025 Positive
Submitted by Anonymous (not verified) on 24 June 2025 - 17:54
Orphan designation: Tertomotide Treatment of progressive supranuclear palsy, 22/05/2025 Positive
Orphan designation: recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1 Treatment of calciphylaxis, 22/05/2025 Positive
Submitted by Anonymous (not verified) on 24 June 2025 - 17:35
Orphan designation: recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1 Treatment of calciphylaxis, 22/05/2025 Positive