1705 results
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Opinion/decision on a Paediatric investigation plan (PIP): ( 2S )-2-[ [ 2-[ ( 4S)-4-( difluo romethyl )-2-oxo-oxazol idin-3-yl ]-5 ,6-dihydro i midazo [ 1,2- d] [ 1,4 ]benzoxazepin-9-yl]amino ]propanamide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002686-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Powder for oral solution
Decision date: 18/03/2020, Last updated: 30/07/2020, Compliance check: Xdifluo romethyl )-2-oxo-oxazol idin-3-yl ]-5 ,6-dihydro i midazo … difluo romethyl )-2-oxo-oxazol idin-3-yl ]-5 ,6-dihydro i midazo … -
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Orphan designation: Autologous tumour-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin for: Treatment of mantle cell lymphoma
Date of designation: 23/02/2011, Positive, Last updated: 04/03/2011tumour-derived immunoglobulin idiotype coupled to keyhole limpet … tumour-derived immunoglobulin idiotype coupled to keyhole limpet … tumor-derived immunoglobulin idiotype coupled to keyhole limpet … -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous tumour-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001274-PIP01-12, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 20/08/2012, Last updated: 17/09/2012, Compliance check: Xtumour-derived immunoglobulin idiotype coupled to keyhole limpet … tumour-derived immunoglobulin idiotype coupled to keyhole limpet … tumour-derived immunoglobulin idiotype coupled to keyhole limpet … -
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Orphan designation: Murine anti-idiotypic antibody against OC125 antibody against CA125 antigen for: Treatment of ovarian cancer
Date of designation: 09/07/2003, Withdrawn, Last updated: 13/01/2014Murine anti-idiotypic antibody against OC125 antibody … Germany, for murine anti-idiotypic antibody against OC125 antibody … antibodies are called 'anti-idiotypic' antibodies. This anti … -
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Orphan designation: Autologous tumour-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin for: Treatment of follicular lymphoma
Date of designation: 28/08/2006, Positive, Last updated: 14/06/2012tumour-derived immunoglobulin idiotype coupled to keyhole limpet … tumor-derived immunoglobulin idiotype coupled to keyhole limpet … tumor-derived immunoglobulin idiotype coupled to keyhole limpet … -
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Orphan designation: Recombinant histidine-tagged idiotype immunoglobulin Fab fragment of clonal B-cell receptors for: Treatment of diffuse large B-cell lymphoma
Date of designation: 24/07/2009, Positive, Last updated: 31/05/2011Recombinant histidine-tagged idiotype immunoglobulin Fab fragment … recombinant histidine-tagged idiotype immunoglobulin Fab fragment … recombinant histidine-tagged idiotype immunoglobulin Fab fragment … -
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Orphan designation: Recombinant histidine-tagged idiotype immunoglobulin Fab fragment of clonal B-cell receptors for: Treatment of follicular lymphoma
Date of designation: 23/12/2004, Positive, Last updated: 31/05/2011Recombinant histidine-tagged idiotype immunoglobulin Fab fragment … idiovax fl 7 Westferry Circus … Recombinant histidine tagged idiotype immunoglobulin Fab fragment … -
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Orphan designation: Recombinant histidine-tagged idiotype immunoglobulin Fab fragment of clonal B-cell receptors for: Treatment of multiple myeloma
Date of designation: 21/12/2004, Positive, Last updated: 01/06/2011Recombinant histidine-tagged idiotype immunoglobulin Fab fragment … recombinant histidine tagged idiotype immunoglobulin Fab fragment … Recombinant histidine tagged idiotype immunoglobulin Fab fragment … -
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Orphan designation: Recombinant histidine-tagged idiotype immunoglobulin Fab fragment of clonal B-cell receptors for: Treatment of mantle cell lymphoma
Date of designation: 21/12/2004, Positive, Last updated: 01/06/2011Recombinant histidine-tagged idiotype immunoglobulin Fab fragment … recombinant histidine tagged idiotype immunoglobulin Fab fragment … Recombinant histidine tagged idiotype immunoglobulin Fab fragment … -
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Human medicine European public assessment report (EPAR): Pirfenidone axunio (previously Pirfenidone AET)
Pirfenidone, Idiopathic Pulmonary Fibrosis
Date of authorisation: 20/06/2022,
, Revision: 2, Authorised, Last updated: 12/10/2022
Diseases Respiratory Tract Diseases Idiopathic Interstitial Pneumonias Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis … adults with mild to moderate idiopathic pulmonary fibrosis (IPF … severe shortness of breath. ‘Idiopathic’ means that the cause of … -
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Human medicine European public assessment report (EPAR): Esbriet
Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 27/02/2011, Revision: 32, Authorised, Last updated: 06/12/2022Esbriet Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Lung … adults with mild to moderate idiopathic pulmonary fibrosis (IPF … severe shortness of breath. ‘Idiopathic’ means that the cause of … -
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Human medicine European public assessment report (EPAR): Ofev
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,
, Revision: 22, Authorised, Last updated: 26/04/2022
Diseases Respiratory Tract Diseases Idiopathic Pulmonary Fibrosis … used to treat adults with: idiopathic pulmonary fibrosis (IPF … -
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Human medicine European public assessment report (EPAR): Pirfenidone Viatris
Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 10/01/2023,, Authorised, Last updated: 17/01/2023
Diseases Respiratory Tract Diseases Idiopathic Pulmonary Fibrosis Lung … adults with mild to moderate idiopathic pulmonary fibrosis (IPF … severe shortness of breath. ‘Idiopathic’ means that the cause of … -
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Direct healthcare professional communication (DHPC): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)
Active substance: Pirfenidone, DHPC type: Type II variation, Last updated: 29/10/2020Drug-Induced Liver Injury (DILI) Idiopathic Pulmonary Fibrosis … Pirfenidone Therapeutic area (MeSH) Idiopathic Pulmonary Fibrosis Procedure … -
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Press release: Adempas not for use in patients with pulmonary hypertension caused by idiopathic interstitial pneumonia
Last updated: 24/06/2016pulmonary hypertension caused by idiopathic interstitial pneumonia … pulmonary hypertension caused by idiopathic interstitial pneumonia … pulmonary hypertension caused by idiopathic interstitial pneumonia … -
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Clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis - Scientific guideline
Last updated: 20/11/2015the treatment of juvenile idiopathic arthritis - Scientific guidel … the treatment of juvenile idiopathic arthritis - Scientific guidel … the treatment of juvenile idiopathic arthritis 30 Churchill …
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Human medicine European public assessment report (EPAR): Nplate
romiplostim, Purpura, Thrombocytopenic, Idiopathic
Date of authorisation: 04/02/2009, Revision: 26, Authorised, Last updated: 17/10/2022Manifestations Purpura, Thrombocytopenic, Idiopathic … Purpura, Thrombocytopenic, Idiopathic Anatomical therapeutic chemical … -
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Need for a guideline on the clinical development of thrombopoetin receptor agonists for the treatment of chronic immune (idiopathic) thrombocytopenic purpura - Scientific guideline
Last updated: 13/06/2010treatment of chronic immune (idiopathic) thrombocytopenic purpura … treatment of chronic immune (idiopathic) thrombocytopenic purpura … treatment of chronic immune (idiopathic) thrombocytopenic purpura …
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Human medicine European public assessment report (EPAR): Revolade
Eltrombopag, Purpura, Thrombocytopenic, Idiopathic
Date of authorisation: 11/03/2010, Revision: 31, Authorised, Last updated: 04/11/2022Manifestations Purpura, Thrombocytopenic, Idiopathic … Purpura, Thrombocytopenic, Idiopathic Anatomical therapeutic chemical … -
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Human medicine European public assessment report (EPAR): Privigen
human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic; Bone Marrow Transplantation; Immunologic Deficiency Syndromes; Guillain-Barre Syndrome; Mucocutaneous Lymph Node Syndrome
Date of authorisation: 24/04/2008, Revision: 30, Authorised, Last updated: 11/10/2022Manifestations Purpura, Thrombocytopenic, Idiopathic Bone Marrow Transplantation Immunologic … Purpura, Thrombocytopenic, Idiopathic Bone Marrow Transplantation … infections Immunomodulation Idiopathic thrombocytopenic purpura … -
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Human medicine European public assessment report (EPAR): Kiovig
human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic; Bone Marrow Transplantation; Immunologic Deficiency Syndromes; Guillain-Barre Syndrome; Mucocutaneous Lymph Node Syndrome
Date of authorisation: 18/01/2006, Revision: 26, Authorised, Last updated: 27/06/2022Manifestations Purpura, Thrombocytopenic, Idiopathic Bone Marrow Transplantation Immunologic … -
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Human medicine European public assessment report (EPAR): Flebogamma DIF (previously Flebogammadif)
Human normal immunoglobulin, Mucocutaneous Lymph Node Syndrome; Guillain-Barre Syndrome; Bone Marrow Transplantation; Purpura, Thrombocytopenic, Idiopathic; Immunologic Deficiency Syndromes
Date of authorisation: 23/07/2007, Revision: 18, Authorised, Last updated: 04/02/2022Transplantation Purpura, Thrombocytopenic, Idiopathic Immunologic Deficiency Syndr … immune system disorders: idiopathic thrombocytopenic purpura … immune system disorders: Idiopathic thrombocytopenic purpura … -
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Human medicine European public assessment report (EPAR): RoActemra
tocilizumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Cytokine Release Syndrome; Giant Cell Arteritis; COVID-19 virus infection
Date of authorisation: 15/01/2009, Revision: 40, Authorised, Last updated: 25/10/2022active systemic juvenile idiopathic arthritis in whom other treatments … years of age with juvenile idiopathic polyarthritis in whom treatment … arthritis, systemic juvenile idiopathic arthritis, juvenile … -
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Human medicine European public assessment report (EPAR): Xeljanz
Tofacitinib, Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,
Date of refusal: 25/04/2013,
, Revision: 26, Authorised, Last updated: 04/10/2022
active polyarticular juvenile idiopathic arthritis (pJIA) or juvenile … arthritis, a subtype of juvenile idiopathic arthritis (JIA), which is … the treatment of juvenile idiopathic arthritis, Xeljanz is taken … -
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Human medicine European public assessment report (EPAR): Orencia
Abatacept, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid
Date of authorisation: 21/05/2007, Revision: 37, Authorised, Last updated: 21/02/2022active polyarticular juvenile idiopathic arthritis (a rare childhood … or polyarticular juvenile idiopathic arthritis. Orencia is available … and polyarticular juvenile idiopathic arthritis. T cells are activated …