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Orphan designation: Tafasitamab Treatment of follicular lymphoma, 26/02/2025 Positive

Orphan designation: Tafasitamab Treatment of follicular...

Mar 11, 2025 0

Orphan designation: Tafasitamab Treatment of follicular lymphoma, 26/02/2025 Pos...

Orphan designation: Rimeporide Treatment of Duchenne muscular dystrophy, 26/02/2025 Positive

Orphan designation: Rimeporide Treatment of Duchenne mu...

Mar 11, 2025 0

Orphan designation: Rimeporide Treatment of Duchenne muscular dystrophy, 26/02/2...

Orphan designation: Treatment of X-linked hypohidrotic ectodermal dysplasia (Christ-Siemens-Touraine Syndrome), 26/02/2025 Positive

Orphan designation: Treatment of X-linked hypohidrotic...

Mar 11, 2025 0

Orphan designation: Treatment of X-linked hypohidrotic ectodermal dysplasia (Ch...

Orphan designation: hydroxocobalamin acetate Treatment of homocystinuria and/or methylmalonic acidaemia due to genetic defects of intracellular cobalamin processing, 26/02/2025 Positive

Orphan designation: hydroxocobalamin acetate Treatment ...

Mar 11, 2025 0

Orphan designation: hydroxocobalamin acetate Treatment of homocystinuria and/or ...

Orphan designation: (R)-(3-(2'-cyclopropyl-3-(hydroxymethyl)-[1,1'-biphenyl]-4-yl)pyrrolidin-1-yl)(5-hydroxy-6-methylpyridin-2-yl)methanone Treatment of Olmsted syndrome, 26/02/2025 Positive

Orphan designation: (R)-(3-(2'-cyclopropyl-3-(hydr...

Mar 11, 2025 0

Orphan designation: (R)-(3-(2'-cyclopropyl-3-(hydroxymethyl)-[1,1'-biphenyl]-4-y...

Orphan designation: adeno-associated virus serotype rh.10 containing the human PKP2 gene Treatment of arrhythmogenic cardiomyopathy caused by pathogenic mutations in the PKP2 gene, 26/02/2025 Positive

Orphan designation: adeno-associated virus serotype rh....

Mar 11, 2025 0

Orphan designation: adeno-associated virus serotype rh.10 containing the human P...

Orphan designation: paltusotine Treatment of acromegaly, 26/02/2025 Positive

Orphan designation: paltusotine Treatment of acromegaly...

Mar 11, 2025 0

Orphan designation: paltusotine Treatment of acromegaly, 26/02/2025 Positive

Orphan designation: adeno-associated virus vector serotype SNY001 containing the human PAH gene Treatment of hyperphenylalaninaemia, 26/02/2025 Positive

Orphan designation: adeno-associated virus vector serot...

Mar 11, 2025 0

Orphan designation: adeno-associated virus vector serotype SNY001 containing the...

Orphan designation: volixibat potassium Treatment of primary sclerosing cholangitis, 26/02/2025 Positive

Orphan designation: volixibat potassium Treatment of pr...

Mar 11, 2025 0

Orphan designation: volixibat potassium Treatment of primary sclerosing cholangi...

Orphan designation: epertinib Treatment of amyotrophic lateral sclerosis, 26/02/2025 Positive

Orphan designation: epertinib Treatment of amyotrophic ...

Mar 11, 2025 0

Orphan designation: epertinib Treatment of amyotrophic lateral sclerosis, 26/02/...

Orphan designation: Autologous CD34+ cell enriched population containing haematopoietic stem and progenitor cells transduced ex vivo with a lentiviral vector encoding the human ADA2 gene Treatment of adenosine deaminase 2 deficiency (DADA2), 27/02/2025 Positive

Orphan designation: Autologous CD34+ cell enriched popu...

Mar 11, 2025 0

Orphan designation: Autologous CD34+ cell enriched population containing haemato...

Orphan designation: adeno-associated virus sector serotype rh74 containing the human SGCG gene Treatment of limb-girdle muscular dystrophy, 27/02/2025 Positive

Orphan designation: adeno-associated virus sector serot...

Mar 11, 2025 0

Orphan designation: adeno-associated virus sector serotype rh74 containing the h...

Quetiapine

Mar 11, 2025 0

Quetiapine

Cancer Medicines Forum: December 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 December 2024, 13:00 (CET) to 16 December 2024, 15:00 (CET)

Cancer Medicines Forum: December 2024, Online, European...

Mar 11, 2025 0

Cancer Medicines Forum: December 2024, Online, European Medicines Agency, Amster...

Human medicines European public assessment report (EPAR): Emcitate, tiratricol, Date of authorisation: 12/02/2025, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 11, 2025 0

Human medicines European public assessment report (EPAR): Emcitate, tiratricol, ...

Presentation - Optimizing the dosage of human prescript...

Mar 11, 2025 0

Presentation - Optimizing the dosage of human prescription drugs and biological ...

Minutes of the Cancer Medicines Forum - December 2024

Mar 11, 2025 0

Minutes of the Cancer Medicines Forum - December 2024

Cancer Medicines Forum: December 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, 16 December 2024

Cancer Medicines Forum: December 2024, Online, European...

Mar 11, 2025 0

Cancer Medicines Forum: December 2024, Online, European Medicines Agency, Amster...

Human medicines European public assessment report (EPAR): Silodosin Recordati, silodosin, Date of authorisation: 07/01/2019, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 10, 2025 0

Human medicines European public assessment report (EPAR): Silodosin Recordati, s...

Human medicines European public assessment report (EPAR): Zefylti, filgrastim, Date of authorisation: 12/02/2025, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 10, 2025 0

Human medicines European public assessment report (EPAR): Zefylti, filgrastim, D...

Human medicines European public assessment report (EPAR): Inaqovi, cedazuridine,decitabine, Date of authorisation: 15/09/2023, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 10, 2025 0

Human medicines European public assessment report (EPAR): Inaqovi, cedazuridine,...

Human medicines European public assessment report (EPAR): Sutent, sunitinib, Date of authorisation: 19/07/2006, Revision: 41, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 10, 2025 0

Human medicines European public assessment report (EPAR): Sutent, sunitinib, Dat...

Human medicines European public assessment report (EPAR): Dimethyl fumarate Accord, dimethyl fumarate, Date of authorisation: 22/04/2024, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 10, 2025 0

Human medicines European public assessment report (EPAR): Dimethyl fumarate Acco...

Human medicines European public assessment report (EPAR): Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.), beclometasone,formoterol, Date of authorisation: 23/04/2018, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 10, 2025 0

Human medicines European public assessment report (EPAR): Riarify (previously CH...

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