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Human medicines European public assessment report (EPAR): Fabhalta, Iptacopan, Date of authorisation: 17/05/2024, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 20, 2025 0

Human medicines European public assessment report (EPAR): Fabhalta, Iptacopan, D...

Frequently asked questions

Frequently asked questions

Feb 20, 2025 0

Frequently asked questions

Human medicines European public assessment report (EPAR): Victoza, liraglutide, Date of authorisation: 30/06/2009, Revision: 25, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 20, 2025 0

Human medicines European public assessment report (EPAR): Victoza, liraglutide, ...

How to recognise scams using EMA credentials

How to recognise scams using EMA credentials

Feb 20, 2025 0

How to recognise scams using EMA credentials

Development of the Clinical Trials Information System

Development of the Clinical Trials Information System

Feb 20, 2025 0

Development of the Clinical Trials Information System

Minutes of the CVMP meeting 14-15 January 2025

Feb 20, 2025 0

Minutes of the CVMP meeting 14-15 January 2025

Orphan designation: Rilzabrutinib Treatment of autoimmune haemolytic anaemia, 16/01/2025 Positive

Orphan designation: Rilzabrutinib Treatment of autoimmu...

Feb 20, 2025 0

Orphan designation: Rilzabrutinib Treatment of autoimmune haemolytic anaemia, 16...

Orphan designation: Clofutriben Treatment of Cushing's syndrome of endogenous origin, 16/01/2025 Positive

Orphan designation: Clofutriben Treatment of Cushing&#0...

Feb 20, 2025 0

Orphan designation: Clofutriben Treatment of Cushing's syndrome of endogenous or...

Orphan designation: zopapogene imadenovec Treatment of recurrent respiratory papillomatosis, 12/01/2024 Positive

Orphan designation: zopapogene imadenovec Treatment of ...

Feb 20, 2025 0

Orphan designation: zopapogene imadenovec Treatment of recurrent respiratory pap...

Orphan designation: N-(2-Methoxyethyl)-6-methyl-N-[(3-methyl-2-thienyl)methyl]-2-oxo-1,2-dihydropyridine-4-carboxamide Treatment of glycogen storage disease type IV, 16/01/2025 Positive

Orphan designation: N-(2-Methoxyethyl)-6-methyl-N-[(3-m...

Feb 20, 2025 0

Orphan designation: N-(2-Methoxyethyl)-6-methyl-N-[(3-methyl-2-thienyl)methyl]-2...

Human medicines European public assessment report (EPAR): Tuznue, trastuzumab, Date of authorisation: 19/09/2024, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 20, 2025 0

Human medicines European public assessment report (EPAR): Tuznue, trastuzumab, D...

Orphan designation: Adeno-associated viral vector serotype 9 containing the human N-acetylglucosaminidase-alpha gene Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome), 24/01/2013 Withdrawn

Orphan designation: Adeno-associated viral vector serot...

Feb 20, 2025 0

Orphan designation: Adeno-associated viral vector serotype 9 containing the huma...

Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector containing the human RAG1 gene Treatment of recombination-activating gene 1 deficient severe combined immunodeficiency, 26/03/2014 Positive

Orphan designation: Autologous CD34+ cells transduced w...

Feb 20, 2025 0

Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector c...

Orphan designation: Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene (etuvetidigene autotemcel) Treatment of Wiskott-Aldrich syndrome, 07/10/2013 Withdrawn

Orphan designation: Autologous CD34+ cells transfected ...

Feb 20, 2025 0

Orphan designation: Autologous CD34+ cells transfected with lentiviral vector co...

Orphan designation: amitriptyline Treatment of erythromelalgia, 21/06/2022 Withdrawn

Orphan designation: amitriptyline Treatment of erythrom...

Feb 20, 2025 0

Orphan designation: amitriptyline Treatment of erythromelalgia, 21/06/2022 Withd...

Orphan designation: Adeno-associated viral vector serotype 9 containing the human iduronate-2-sulfatase gene Treatment of mucopolysaccharidosis type II (Hunter's syndrome), 10/08/2015 Withdrawn

Orphan designation: Adeno-associated viral vector serot...

Feb 20, 2025 0

Orphan designation: Adeno-associated viral vector serotype 9 containing the huma...

Orphan designation: Adeno-associated virus serotype 5 vector encoding C1-esterase inhibitor Treatment of hereditary angioedema, 10/11/2022 Withdrawn

Orphan designation: Adeno-associated virus serotype 5 v...

Feb 20, 2025 0

Orphan designation: Adeno-associated virus serotype 5 vector encoding C1-esteras...

Orphan designation: xevinapant Treatment of ovarian cancer, 11/11/2015 Withdrawn

Orphan designation: xevinapant Treatment of ovarian can...

Feb 20, 2025 0

Orphan designation: xevinapant Treatment of ovarian cancer, 11/11/2015 Withdrawn

Orphan designation: volixibat potassium Treatment of primary biliary cholangitis, 16/01/2025 Positive

Orphan designation: volixibat potassium Treatment of pr...

Feb 20, 2025 0

Orphan designation: volixibat potassium Treatment of primary biliary cholangitis...

Human medicines European public assessment report (EPAR): Imfinzi, durvalumab, Date of authorisation: 21/09/2018, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 20, 2025 0

Human medicines European public assessment report (EPAR): Imfinzi, durvalumab, D...

Orphan designation: Allogenic umbilical cord-derived osteoblast cells Treatment of non-traumatic osteonecrosis, 16/01/2025 Positive

Orphan designation: Allogenic umbilical cord-derived os...

Feb 20, 2025 0

Orphan designation: Allogenic umbilical cord-derived osteoblast cells Treatment ...

Orphan designation: Elraglusib Treatment of soft tissue sarcoma, 16/01/2025 Positive

Orphan designation: Elraglusib Treatment of soft tissue...

Feb 20, 2025 0

Orphan designation: Elraglusib Treatment of soft tissue sarcoma, 16/01/2025 Posi...

Orphan designation: [4-(Methyl-1H-pyrazol-4-yl)-benzyl]-(6[7-(3-pyrrolidin-1-yl-propoxy)-imidazo[1,2-a]pyridin-3-yl]-pyrimidin-4-yl]-amine Treatment of gastrointestinal stromal tumours, 16/01/2025 Positive

Orphan designation: [4-(Methyl-1H-pyrazol-4-yl)-benzyl]...

Feb 20, 2025 0

Orphan designation: [4-(Methyl-1H-pyrazol-4-yl)-benzyl]-(6[7-(3-pyrrolidin-1-yl-...

DARWIN EU data partners onboarded in phases I, II and III

Feb 20, 2025 0

DARWIN EU data partners onboarded in phases I, II and III

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