595 results
Keyword Thalidomide BMS Remove keyword
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Human medicine European public assessment report (EPAR): Thalidomide BMS (previously Thalidomide Celgene)
Thalidomide, Multiple Myeloma
Date of authorisation: 16/04/2008, Revision: 30, Authorised, Last updated: 01/07/2022Thalidomide BMS (previously Thalidomide Celgene) Cancer Neoplasms Neoplasms … Thalidomide BMS (previously Thalidomide Celgene … THE POSITIVE OPINION for THALIDOMIDE PHARMION International … -
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Human medicine European public assessment report (EPAR): Thalidomide Lipomed
Thalidomide, Multiple Myeloma
Date of authorisation: 19/09/2022, Authorised, Last updated: 20/10/2022Thalidomide Lipomed Neoplasms, Plasma … Thalidomide Lipomed is a medicine used … contains the active substance thalidomide. Thalidomide Lipomed is a ‘hybrid medicine’ … -
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Opinion/decision on a Paediatric investigation plan (PIP): Clopidogrel BMS, clopidogrel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: Clopidogrel, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Film-coated tablet
Decision date: 22/09/2009, Last updated: 07/12/2009, Compliance check: XKey facts Clopidogrel BMS clopidogrel Cardiovascular … clopidogrel (Clopidogrel BMS) ... PDF icon application/pdf … EMEA/583696/2009 Generic Clopidogrel BMS: EPAR Clopidogrel … -
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Orphan designation: Thalidomide for: Treatment of multiple myeloma
Date of designation: 20/11/2001, Withdrawn, Last updated: 18/07/2018Thalidomide … opinion on orphan designation Thalidomide for the treatment of multiple … Ltd, United Kingdom, for thalidomide for the treatment of multiple … -
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Orphan designation: Thalidomide for: Treatment of hereditary haemorrhagic telangiectasia
Date of designation: 27/02/2017, Positive, Last updated: 31/03/2017Thalidomide … opinion on orphan designation Thalidomide for the treatment of hereditary … opinion on orphan designation Thalidomide for the treatment of hereditary … -
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Orphan designation: Thalidomide for: Treatment of erythema nodosum leprosum (ENL) or type II lepra reactions
Date of designation: 20/11/2001, Withdrawn, Last updated: 18/11/2010Thalidomide … opinion on orphan designation thalidomide for the treatment of erythema … Ltd., United Kingdom, for thalidomide for the treatment of erythema … -
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Orphan designation: Thalidomide for: Treatment of multiple myeloma
Date of designation: 09/07/2001, Withdrawn, Last updated: 15/10/2009Thalidomide … thalidomide for the treatment of multiple … orphan designation of thalidomide for the treatment of multiple … -
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Orphan designation: Thalidomide for: Treatment of graft-versus-host disease
Date of designation: 09/07/2001, Withdrawn, Last updated: 15/10/2009Thalidomide … thalidomide for the treatment of graft … orphan designation of thalidomide for the treatment of graft … -
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Orphan designation: Thalidomide for: Treatment of multiple myeloma
Date of designation: 19/12/2001, Withdrawn, Last updated: 15/10/2009Thalidomide … thalidomide for the treatment of multiple … orphan designation of thalidomide for the treatment of multiple … -
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Orphan designation: Thalidomide for: Treatment of erythema nodosum leprosum (ENL) or type II lepra reactions
Date of designation: 29/12/2000, Withdrawn, Last updated: 15/05/2009Thalidomide … orphan designation of thalidomide for the treatment of erythema … Laboratoires LAPHAL, France, for thalidomide for the treatment of erythema … -
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Human medicine European public assessment report (EPAR): Nivolumab BMS
nivolumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/07/2015, Withdrawn, Last updated: 14/01/2016Nivolumab BMS Carcinoma, Non-Small-Cell … Nivolumab BMS … Public statement Nivolumab BMS Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Irbesartan BMS
irbesartan, Hypertension
Date of authorisation: 19/01/2007, Revision: 7, Withdrawn, Last updated: 26/11/2009Irbesartan BMS Hypertension … Irbesartan BMS … blic Statemnet on Irbesartan BMS Withdrawal European … -
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Human medicine European public assessment report (EPAR): Irbesartan Hydrochlorothiazide BMS
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 19/01/2007, Revision: 8, Withdrawn, Last updated: 24/11/2009besartan Hydrochlorothiazide BMS Hypertension … besartan Hydrochlorothiazide BMS … Irbesartan Hydrochlorothiazide BMS (irbesartan/hydrochlorothiazide … -
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Human medicine European public assessment report (EPAR): Clopidogrel BMS
clopidogrel (as hydrogen sulfate), Stroke; Peripheral Vascular Diseases; Myocardial Infarction; Acute Coronary Syndrome
Date of authorisation: 16/07/2008, Revision: 3, Withdrawn, Last updated: 26/01/2010Clopidogrel BMS Stroke Peripheral Vascular … Clopidogrel BMS … Microsoft Word - Clopidogrel BMS Public Statement.doc … -
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Opinion/decision on a Paediatric investigation plan (PIP): PEGylated-fibroblast growth factor 21 (BMS-986036)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002448-PIP01-18-M02, Route(s) of administration: Subcutaneous use,
Decision date: 18/08/2021, Last updated: 05/01/2023, Compliance check: XPEGylated-fibroblast growth factor 21 (BMS-986036) Therapeutic area … Pegylated-fibroblast growth factor 21 (BMS-986036) Invented name … fibrosis, Bristol Myers Squibb (BMS) has decided no longer to … -
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Opinion/decision on a Paediatric investigation plan (PIP): Humanised IgG4 monoclonal antibody against extracellular tau (BMS-986168)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-001867-PIP01-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 19/02/2016, Last updated: 25/04/2016, Compliance check: Xagainst extracellular tau (BMS-986168) NeurologyP/0041/2016EMEA-001867-PIP01-15 … against extracellular tau (BMS-986168) (EMEA-001867-PIP01-15 … against extracellular tau (BMS-986168) (EMEA-001867-PIP01-15 … -
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Opinion/decision on a Paediatric investigation plan (PIP): 1-(2R,5R)-5-ethynyl-5-(hydroxymethyl)-2,5-dihydro-2-furanyl)-5-methyl-2,4(1H,3H)-pyrimidinedione (BMS-986001)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001288-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 27/03/2013, Last updated: 03/05/2013, Compliance check: X1-(2R,5R)-5-ethynyl-5-(hydroxymethyl)-2,5-dihydro-2-furanyl)-5-methyl-2,4(1H,3H)-pyrimidinedione (BMS-986001) Infectious diseasesP/0082/2013EMEA-001288-PIP01-12 … 1-(2R,5R)-5-ethynyl-5-(hydroxymethyl)-2,5-dihydro-2-furanyl)-5-methyl-2,4(1H,3H)-pyrimidinedione (BMS-986001), (EMEA-001288-PIP01-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): (1S,3S)-3-({2-methyl-6-[1-methyl-5-({[methyl(propyl)carbamoyl]oxy}methyl)-1H-1,2,3-triazol-4-yl]pyridin-3-yl}oxy)cyclohexane-1-carboxylic acid (BMS-986278)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001649-PIP02-21, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 11/03/2022, Last updated: 13/04/2023, Compliance check: X1S,3S)-3-({2-methyl-6-[1-methyl-5-({[methyl(propyl)carbamoyl]oxy}methyl)-1H-1,2,3-triazol-4-yl]pyridin-3-yl}oxy)cyclohexane-1-carboxylic acid (BMS-986278) Pneumology-allergologyP/0079/2022EMEA-001649-PIP02-21 … 1S,3S)-3-({2-methyl-6-[1-methyl-5- ({[methyl(propyl)carbamoyl]oxy}methyl)-1H-1,2,3-triazol-4-yl]pyridin-3-yl}oxy)cyclohexane-1- carboxylic acid (BMS-986278) (EMEA-001649-PIP02-21 … -
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Opinion/decision on a Paediatric investigation plan (PIP): B cell maturation antigen antibody-drug conjugate comprised of an immunoglobulin G1 humanized antibody conjugated covalently to the dibenzocyclooctyne noncleavable linker maytansinoid warhead (BMS-986352)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-003047-PIP01-21, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 29/10/2010, Last updated: 22/02/2023, Compliance check: Xlinker maytansinoid warhead (BMS-986352) Therapeutic area … linker maytansinoid warhead (BMS-986352), (EMEA-003047-PIP01- 21 … linker maytansinoid warhead (BMS-986352), (EMEA-003047-PIP01- 21 … -
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Opinion/decision on a Paediatric investigation plan (PIP): asunaprevir, (1aR,12bS)-8-Cyclohexyl-N-(dimethylsulfamoyl)-11-methoxy-1a-(((1R,5S)-3-methyl-3,8-diazabicyclo[3.2.1]oct-8-yl)carbonyl)-1,1a,2,12b-tetrahydrocyclopropa[d]indolo[2,1-a][2]benzazepine-5-carboxamide hydrochloride (BMS-791325), daclatasvir dihydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001485-PIP01-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Film-coated tablet
Decision date: 15/01/2015, Last updated: 20/08/2015, Compliance check: X1aR,12bS)-8-Cyclohexyl-N-(dimethylsulfamoyl)-11-methoxy-1a-(((1R,5S)-3-methyl-3,8-diazabicyclo[3.2.1]oct-8-yl)carbonyl)-1,1a,2,12b-tetrahydrocyclopropa[d]indolo[2,1-a][2]benzazepine-5-carboxamide hydrochloride (BMS-791325) daclatasvir dihydrochloride … 1ar,12bs)-8-Cyclohexyl-N-(dimethylsulfamoyl)-11-methoxy-1a-(((1R,5S)-3-methyl-3,8-diazabicyclo[3.2.1]oct-8-yl)carbonyl)-1,1a,2,12b-tetrahydrocyclopropa[d]indolo[2,1-a][2]benzazepine-5-carboxamide hydrochloride (BMS-791325) for the treatment … -
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Thalidomide - Follow-up meeting with patients' and victims' organisations
European Medicines Agency, London, UK, 05/09/2011, Last updated: 02/09/2011Thalidomide - Follow-up meeting with … Thalidomide - Follow-up meeting with … and Evaluation Minutes of Thalidomide follow-up meeting with patients’ … -
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Press release: European Medicines Agency recommends the approval of thalidomide for the treatment of rare bone-marrow cancer
CHMP, Last updated: 24/01/2008recommends the approval of thalidomide for the treatment of rare … recommends the approval of thalidomide for the treatment of rare … recommends the approval of thalidomide for the treatment of rare … -
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Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,
, 
, Revision: 20, Authorised, Last updated: 22/03/2023
combination with bortezomib, thalidomide (another medicine used to … -
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Orphan designation: Pomalidomide for: Treatment of multiple myeloma
Date of designation: 08/10/2009, Positive, Last updated: 10/06/2021such as lenalidomide and thalidomide: it is expected to block the … such as lenalidomide and thalidomide: it is expected to block the … -
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Human medicine European public assessment report (EPAR): Bortezomib Accord
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,
, Revision: 13, Authorised, Last updated: 25/03/2022
or with dexamethasone plus thalidomide. Bortezomib Accord is also … or with dexamethasone plus thalidomide. Bortezomib Accord is also …