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Wyszukujesz frazę ""Tzogani, K"" wg kryterium: Wszystkie pola


Tytuł :
Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit-The EU Regulator's Perspective.
Autorzy :
Sheean ME; European Medicines Agency, Amsterdam, Netherlands.
Naumann-Winter F; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, Netherlands.; Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.
Capovilla G; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, Netherlands.; Carlo Poma Hospital, Mantova, Italy.; Fondazione Poliambulanza, Brescia, Italy.
Kalland ME; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, Netherlands.; Statens Legemiddelverk, Oslo, Norway.
Malikova E; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, Netherlands.; State Institute for Drug Control, Bratislava, Slovakia.; Department of Pharmacology and Toxicology, Comenius University, Bratislava, Slovakia.
Mariz S; European Medicines Agency, Amsterdam, Netherlands.
Matusevicius D; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, Netherlands.; Läkemedelsverket, Uppsala, Sweden.
Nistico R; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, Netherlands.; Malta Medicines Authority, San Gwann, Malta.
Schwarzer-Daum B; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, Netherlands.; Medical University of Vienna, Vienna, Austria.
Tsigkos S; European Medicines Agency, Amsterdam, Netherlands.
Tzogani K; European Medicines Agency, Amsterdam, Netherlands.
Larsson K; European Medicines Agency, Amsterdam, Netherlands.
Magrelli A; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, Netherlands.; National Center for Drug Research and Evaluation, Istituto Superiore di Sanità, Rome, Italy.
Stoyanova-Beninska V; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, Netherlands.; College ter Beoordeling van Geneesmiddelen, Utrecht, Netherlands.
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Źródło :
Frontiers in medicine [Front Med (Lausanne)] 2021 Aug 27; Vol. 8, pp. 744625. Date of Electronic Publication: 2021 Aug 27 (Print Publication: 2021).
Typ publikacji :
Journal Article
Czasopismo naukowe
Tytuł :
EMA Review of Belantamab Mafodotin (Blenrep) for the Treatment of Adult Patients with Relapsed/Refractory Multiple Myeloma.
Autorzy :
Tzogani K; European Medicines Agency, Amsterdam, The Netherlands.
Penttilä K; Lääkealan turvallisuus- ja kehittämiskeskus, Fimea, Finland.; The Committee for Medicinal Products for Human Use (CHMP).
Lähteenvuo J; Lääkealan turvallisuus- ja kehittämiskeskus, Fimea, Finland.; The Committee for Medicinal Products for Human Use (CHMP).
Lapveteläinen T; Lääkealan turvallisuus- ja kehittämiskeskus, Fimea, Finland.; The Committee for Medicinal Products for Human Use (CHMP).
Lopez Anglada L; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.; The Committee for Medicinal Products for Human Use (CHMP).
Prieto C; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.; The Committee for Medicinal Products for Human Use (CHMP).
Garcia-Ochoa B; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.; The Committee for Medicinal Products for Human Use (CHMP).
Enzmann H; Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.; The Committee for Medicinal Products for Human Use (CHMP).
Gisselbrecht C; Hospital Saint Louis, Paris, France.
Delgado J; European Medicines Agency, Amsterdam, The Netherlands.
Pignatti F; European Medicines Agency, Amsterdam, The Netherlands.
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Źródło :
The oncologist [Oncologist] 2021 Jan; Vol. 26 (1), pp. 70-76. Date of Electronic Publication: 2020 Nov 23.
Typ publikacji :
Clinical Trial, Phase II; Journal Article; Multicenter Study
MeSH Terms :
Antineoplastic Agents, Immunological*/therapeutic use
Immunoconjugates*/therapeutic use
Multiple Myeloma*/drug therapy
Adult ; Antibodies, Monoclonal, Humanized/therapeutic use ; Humans
Czasopismo naukowe
Tytuł :
EMA Review of Axicabtagene Ciloleucel (Yescarta) for the Treatment of Diffuse Large B-Cell Lymphoma.
Autorzy :
Papadouli I; European Medicines Agency, Amsterdam, The Netherlands.
Mueller-Berghaus J; Paul-Ehrlich-Institut, Langen, Germany.
Beuneu C; Federal Agency for Medicines and Health Products, Brussels, Belgium.
Ali S; European Medicines Agency, Amsterdam, The Netherlands.
Hofner B; Paul-Ehrlich-Institut, Langen, Germany.
Petavy F; European Medicines Agency, Amsterdam, The Netherlands.
Tzogani K; European Medicines Agency, Amsterdam, The Netherlands.
Miermont A; Federal Agency for Medicines and Health Products, Brussels, Belgium.
Norga K; Federal Agency for Medicines and Health Products, Brussels, Belgium.; Paediatric Oncology, Antwerp University Hospital, Edegem, Belgium.
Kholmanskikh O; Federal Agency for Medicines and Health Products, Brussels, Belgium.
Leest T; Federal Agency for Medicines and Health Products, Brussels, Belgium.
Schuessler-Lenz M; Paul-Ehrlich-Institut, Langen, Germany.
Salmonson T; Medical Products Agency, Uppsala, Sweden.
Gisselbrecht C; Hôpital Saint Louis Institut d'Hématologie, Paris, France.
Garcia JL; European Medicines Agency, Amsterdam, The Netherlands.
Pignatti F; European Medicines Agency, Amsterdam, The Netherlands.
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Źródło :
The oncologist [Oncologist] 2020 Oct; Vol. 25 (10), pp. 894-902. Date of Electronic Publication: 2020 Apr 27.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Lymphoma, Large B-Cell, Diffuse*/drug therapy
Receptors, Chimeric Antigen*/genetics
Adult ; Antigens, CD19/therapeutic use ; Humans ; Immunotherapy, Adoptive
Czasopismo naukowe
Tytuł :
Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies
Autorzy :
Velikova, G
Thanarajasingam, G
Minasian, LM
Baron, F
Cavalli, F
De Claro, RA
Dueck, AC
El-Galaly, TC
Everest, N
Geissler, J
Gisselbrecht, C
Gribben, J
Horowitz, M
Ivy, SP
Jacobson, CA
Keating, A
Kluetz, PG
Krauss, A
Kwong, YL
Little, RF
Mahon, F-X
Matasar, MJ
Mateos, M-V
McCullough, K
Miller, RS
Mohty, M
Moreau, P
Morton, LM
Nagai, S
Rule, S
Sloan, J
Sonneveld, P
Thompson, CA
Tzogani, K
Van Leeuwen, FE
Villa, D
Wingard, JR
Wintrich, S
Seymour, JF
Habermann, TM
Pokaż więcej
Temat :
Hematology [Human health sciences]
Hématologie [Sciences de la santé humaine]
Źródło :
Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies. Lancet. Haematology, 5, 563-598., United KingdomElsevier. (2018).
Opis pliku :
application/pdf
Tytuł :
EMA Review of Daunorubicin and Cytarabine Encapsulated in Liposomes (Vyxeos, CPX-351) for the Treatment of Adults with Newly Diagnosed, Therapy-Related Acute Myeloid Leukemia or Acute Myeloid Leukemia with Myelodysplasia-Related Changes.
Autorzy :
Tzogani K; European Medicines Agency, Amsterdam, The Netherlands.
Penttilä K; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Finnish Medicines Agency, Fimea, Finland.
Lapveteläinen T; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Finnish Medicines Agency, Fimea, Finland.
Hemmings R; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom.
Koenig J; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Federal Institute for Drugs and Medical Devices, Bonn, Germany.
Freire J; Pharmacovigilance Risk Assessment Committee (PRAC), Amsterdam, The Netherlands.; INFARMED, IP, Lisboa, Portugal.
Márcia S; Pharmacovigilance Risk Assessment Committee (PRAC), Amsterdam, The Netherlands.; INFARMED, IP, Lisboa, Portugal.
Cole S; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom.
Coppola P; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom.
Flores B; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom.
Barbachano Y; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom.
Roige SD; European Medicines Agency, Amsterdam, The Netherlands.
Pignatti F; European Medicines Agency, Amsterdam, The Netherlands.
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Źródło :
The oncologist [Oncologist] 2020 Sep; Vol. 25 (9), pp. e1414-e1420. Date of Electronic Publication: 2020 Apr 13.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Leukemia, Myeloid, Acute*/drug therapy
Liposomes*
Adult ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Cytarabine/therapeutic use ; Daunorubicin ; Humans ; Ireland
Czasopismo naukowe
Tytuł :
The European Medicines Agency Review of Gilteritinib (Xospata) for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an FLT3 Mutation.
Autorzy :
Tzogani K; European Medicines Agency, Amsterdam, The Netherlands.
Røshol H; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Statens legemiddelverk, Oslo, Norway.
Olsen HH; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Statens legemiddelverk, Oslo, Norway.
Aas IB; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Statens legemiddelverk, Oslo, Norway.
Dalhus ML; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Statens legemiddelverk, Oslo, Norway.
Håkonsen GD; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Statens legemiddelverk, Oslo, Norway.
Nilssen LS; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Statens legemiddelverk, Oslo, Norway.
Lindberg V; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Statens legemiddelverk, Oslo, Norway.
Økvist M; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Statens legemiddelverk, Oslo, Norway.
Bolstad B; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Statens legemiddelverk, Oslo, Norway.
Rogovska I; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Zāļu valsts aǵentūra, Riga, Latvia.
Karpova N; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Zāļu valsts aǵentūra, Riga, Latvia.
Enzmann H; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.
Gisselbrecht C; Hospital Saint Louis, Paris, France.
Pignatti F; European Medicines Agency, Amsterdam, The Netherlands.
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Źródło :
The oncologist [Oncologist] 2020 Jul; Vol. 25 (7), pp. e1070-e1076. Date of Electronic Publication: 2020 Mar 10.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Leukemia, Myeloid, Acute*/drug therapy
Leukemia, Myeloid, Acute*/genetics
fms-Like Tyrosine Kinase 3*/genetics
Adult ; Aniline Compounds ; Humans ; Multicenter Studies as Topic ; Mutation ; Pyrazines
Czasopismo naukowe
Tytuł :
Blinatumomab for Acute Lymphoblastic Leukemia: The First Bispecific T-Cell Engager Antibody to Be Approved by the EMA for Minimal Residual Disease.
Autorzy :
Ali S; European Medicines Agency, Amsterdam, The Netherlands.
Moreau A; French National Agency for Medicines and Health Products Safety, Saint-Denis Cedex, France.
Melchiorri D; Department of Physiology and Pharmacology, University of Rome, Sapienza, Rome, Italy.
Camarero J; Spanish Medicines Agency, Madrid, Spain.
Josephson F; Medical Products Agency, Department of Efficacy and Safety 3, Uppsala, Sweden.
Olimpier O; Italian Medicines Agency, European Assessment Unit, Rome, Italy.
Bergh J; Department of Oncology-Pathology, Karolinska Institutet, BES, Cancer Theme, Karolinska University Hospital Bioclinicum, Solna, Sweden.
Karres D; European Medicines Agency, Amsterdam, The Netherlands.
Tzogani K; European Medicines Agency, Amsterdam, The Netherlands.
Gisselbrecht C; Hôpital Saint Louis, Institut d'Hématalogie, Paris, France.
Pignatti F; European Medicines Agency, Amsterdam, The Netherlands.
Pokaż więcej
Źródło :
The oncologist [Oncologist] 2020 Apr; Vol. 25 (4), pp. e709-e715. Date of Electronic Publication: 2019 Nov 14.
Typ publikacji :
Journal Article
MeSH Terms :
Antibodies, Bispecific*/therapeutic use
Antineoplastic Agents*/therapeutic use
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma*/drug therapy
Precursor Cell Lymphoblastic Leukemia-Lymphoma*/drug therapy
Adult ; Child ; Europe ; Humans ; Neoplasm, Residual ; T-Lymphocytes
Czasopismo naukowe
Tytuł :
The European Medicines Agency Review of Kymriah (Tisagenlecleucel) for the Treatment of Acute Lymphoblastic Leukemia and Diffuse Large B-Cell Lymphoma.
Autorzy :
Ali S; European Medicines Agency, Amsterdam, The Netherlands.
Kjeken R; Norwegian Medicines Agency, Oslo, Norway.
Niederlaender C; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom.
Markey G; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom.
Saunders TS; Committee for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.; Norwegian Medicines Agency, Oslo, Norway.
Opsata M; Committee for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.; Norwegian Medicines Agency, Oslo, Norway.
Moltu K; Committee for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.; Norwegian Medicines Agency, Oslo, Norway.
Bremnes B; Committee for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.; Norwegian Medicines Agency, Oslo, Norway.
Grønevik E; Committee for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.; Norwegian Medicines Agency, Oslo, Norway.
Muusse M; Committee for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.; Norwegian Medicines Agency, Oslo, Norway.
Håkonsen GD; Committee for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.; Norwegian Medicines Agency, Oslo, Norway.
Skibeli V; Committee for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.; Norwegian Medicines Agency, Oslo, Norway.
Kalland ME; Committee for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.; Norwegian Medicines Agency, Oslo, Norway.
Wang I; Committee for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.; Norwegian Medicines Agency, Oslo, Norway.
Buajordet I; Committee for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.; Norwegian Medicines Agency, Oslo, Norway.
Urbaniak A; Committee for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.; Norwegian Medicines Agency, Oslo, Norway.
Johnston J; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom.
Rantell K; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom.
Kerwash E; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom.
Schuessler-Lenz M; Committee for Advanced Therapies, European Medicines Agency, Amsterdam, The Netherlands.; Paul-Ehrlich-Institut, Langen, Germany.
Salmonson T; Committee for Medicinal Products for Human Use, European Medicines Agency, Amsterdam, The Netherlands.; Medical Products Agency, Uppsala, Sweden.
Bergh J; Scientific Advisory Group, European Medicines Agency, Amsterdam, The Netherlands.; Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.; Karolinska University Hospital BioClinicum, New Karolinska Hospital, Solna, Sweden.
Gisselbrecht C; Scientific Advisory Group, European Medicines Agency, Amsterdam, The Netherlands.; Institut d'Hématologie, Hôpital Saint Louis, Paris, France.
Tzogani K; European Medicines Agency, Amsterdam, The Netherlands.
Papadouli I; European Medicines Agency, Amsterdam, The Netherlands.
Pignatti F; European Medicines Agency, Amsterdam, The Netherlands.
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Źródło :
The oncologist [Oncologist] 2020 Feb; Vol. 25 (2), pp. e321-e327. Date of Electronic Publication: 2019 Oct 16.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Lymphoma, Large B-Cell, Diffuse*/drug therapy
Precursor Cell Lymphoblastic Leukemia-Lymphoma*/drug therapy
Receptors, Chimeric Antigen*/genetics
Child ; Humans ; Immunotherapy, Adoptive ; Receptors, Antigen, T-Cell/genetics
Czasopismo naukowe
Tytuł :
European Medicines Agency review of midostaurin (Rydapt) for the treatment of adult patients with acute myeloid leukaemia and systemic mastocytosis.
Autorzy :
Tzogani K; European Medicines Agency, Amsterdam, The Netherlands Kyriaki.Tzogani@ema.europa.eu.
Yu Y; Medicines Evaluation Board, Utrecht, The Netherlands.
Meulendijks D; Medicines Evaluation Board, Utrecht, The Netherlands.
Herberts C; Medicines Evaluation Board, Utrecht, The Netherlands.
Hennik P; Medicines Evaluation Board, Utrecht, The Netherlands.
Verheijen R; Medicines Evaluation Board, Utrecht, The Netherlands.
Wangen T; Statens legemiddelverk, Oslo, Norway.
Dahlseng Håkonsen G; Statens legemiddelverk, Oslo, Norway.
Kaasboll T; Statens legemiddelverk, Oslo, Norway.
Dalhus M; Statens legemiddelverk, Oslo, Norway.
Bolstad B; Statens legemiddelverk, Oslo, Norway.
Salmonson T; European Medicines Agency, Amsterdam, The Netherlands.
Gisselbrecht C; Institut d hématologie Hôpital Saint Louis Paris Diderot université, Hospital Saint-Louis, Paris, France.
Pignatti F; European Medicines Agency, Amsterdam, The Netherlands.
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Źródło :
ESMO open [ESMO Open] 2019 Nov; Vol. 4 (6).
Typ publikacji :
Journal Article; Review
MeSH Terms :
Antineoplastic Combined Chemotherapy Protocols/*administration & dosage
Leukemia, Myeloid, Acute/*drug therapy
Mastocytosis, Systemic/*drug therapy
Protein Kinase Inhibitors/*adverse effects
Staurosporine/*analogs & derivatives
Administration, Oral ; Adult ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Diarrhea/chemically induced ; Diarrhea/epidemiology ; Disease-Free Survival ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Drug Approval ; Edema/chemically induced ; Edema/epidemiology ; European Union ; Fatigue/chemically induced ; Fatigue/epidemiology ; Female ; Humans ; Leukemia, Myeloid, Acute/genetics ; Leukemia, Myeloid, Acute/mortality ; Male ; Mastocytosis, Systemic/genetics ; Mastocytosis, Systemic/mortality ; Middle Aged ; Nausea/chemically induced ; Nausea/epidemiology ; Protein Kinase Inhibitors/administration & dosage ; Randomized Controlled Trials as Topic ; Risk Assessment ; Staurosporine/administration & dosage ; Staurosporine/adverse effects ; Vomiting/chemically induced ; Vomiting/epidemiology ; fms-Like Tyrosine Kinase 3/antagonists & inhibitors ; fms-Like Tyrosine Kinase 3/genetics
Czasopismo naukowe
Tytuł :
European Medicines Agency review of ixazomib (Ninlaro) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Autorzy :
Tzogani K; European Medicines Agency, Amsterdam, The Netherlands.
Florez B; MHRA, London, UK.
Markey G; MHRA, London, UK.
Caleno M; AIFA, Roma, Italy.
Olimpieri OM; AIFA, Roma, Italy.
Melchiorri D; Dip. Physiology and Pharmacology, V. Erspamer, University of Rome La Sapienza, Roma, Italy.
Hovgaard DJ; Laegemiddelstyrelsen, Kobenhavn, Denmark.
Sarac SB; Laegemiddelstyrelsen, Kobenhavn, Denmark.
Penttilä K; Finnish Medicines Agency Fimea, Helsinki, Finland.
Lapveteläinen T; Finnish Medicines Agency Fimea, Helsinki, Finland.
Salmonson T; Lakemedelsverket, Uppsala, Sweden.
Bergh J; Radiumhemmet Microbiology and Tumorbiology Center, Karolinska University Hospital, Stockholm, Sweden.
Gisselbrecht C; Institut d'Hématologie, Hôpital Saint Louis Paris Diderot Université, Hospital Saint-Louis, Paris, France.
Pignatti F; European Medicines Agency, Amsterdam, The Netherlands.
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Źródło :
ESMO open [ESMO Open] 2019 Sep 08; Vol. 4 (5), pp. e000570. Date of Electronic Publication: 2019 Sep 08 (Print Publication: 2019).
Typ publikacji :
Journal Article; Review
Czasopismo naukowe
Tytuł :
Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.
Autorzy :
Thanarajasingam G; Division of Haematology, Mayo Clinic, Rochester, MN, USA. Electronic address: .
Minasian LM; National Cancer Institute, National Institutes of Health, Department of Health & Human Services, Bethesda, MD, USA.
Baron F; Division of Haematology, University of Liege, Liege, Belgium.
Cavalli F; Oncology Institute of Southern Switzerland, Bellinzona, Switzlerand.
De Claro RA; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Dueck AC; Department of Health Sciences Research, Mayo Clinic, Scottsdale, AZ, USA.
El-Galaly TC; Department of Haematology, Aalborg University Hospital, Aalborg Denmark.
Everest N; Haematology Clinical Evaluation Unit, Therapeutic Goods Administration, Department of Health, Symondston, ACT, Australia.
Geissler J; Leukaemia Patient Advocates Foundation, Bern, Switzerland.
Gisselbrecht C; Haemato-Oncology Department, Hopital Saint-Louis, Paris Diderot University VII, Paris, France.
Gribben J; Centre for Haemato-Oncology, Barts Cancer Institute, London, UK.
Horowitz M; Division of Haematology and Oncology, Medical College of Wisconsin, Milwaukee, WI, USA.
Ivy SP; National Cancer Institute, National Institutes of Health, Department of Health & Human Services, Bethesda, MD, USA.
Jacobson CA; Division of Haematologic Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Keating A; Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
Kluetz PG; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Krauss A; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Kwong YL; Department of Haematology and Haematologic Oncology, University of Hong Kong, Hong Kong, China.
Little RF; National Cancer Institute, National Institutes of Health, Department of Health & Human Services, Bethesda, MD, USA.
Mahon FX; University of Bordeaux Cancer Institute, Bordeaux, France.
Matasar MJ; Lymphoma and Adult BMT Services, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Mateos MV; Haematology Department, University Hospital of Salamanca-IBSAL, Salamanca, Spain.
McCullough K; Division of Haematology, Mayo Clinic, Rochester, MN, USA.
Miller RS; CancerLinQ, American Society of Clinical Oncology, Alexandria, VA, USA.
Mohty M; Haematology and Cellular Therapy Department, Saint-Antoine Hospital, University Pierre & Marie Curie, Paris, France.
Moreau P; University Hospital of Nantes, Nantes, France.
Morton LM; National Cancer Institute, National Institutes of Health, Department of Health & Human Services, Bethesda, MD, USA.
Nagai S; University of Tokyo, Tokyo, Japan; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Rule S; Plymouth University Medical School, Plymouth, UK.
Sloan J; Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.
Sonneveld P; Department of Haematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.
Thompson CA; Division of Haematology, Mayo Clinic, Rochester, MN, USA.
Tzogani K; European Medicines Agency, London, UK.
van Leeuwen FE; Netherlands Cancer Institute, Amsterdam, Netherlands.
Velikova G; Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK.
Villa D; Division of Medical Oncology, British Columbia Cancer Agency, University of British Columbia, Vancouver, BC, Canada.
Wingard JR; Division of Haematology & Oncology, University of Florida College of Medicine, Gainesville, FL, USA.
Wintrich S; Myelodysplastic Syndrome (MDS) Alliance and MDS UK Patient Support Group, London, UK.
Seymour JF; Department of Haematology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Royal Melbourne Hospital, Melbourne, VIC, Australia; University of Melbourne, Melbourne, VIC, Australia.
Habermann TM; Division of Haematology, Mayo Clinic, Rochester, MN, USA.
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Źródło :
The Lancet. Haematology [Lancet Haematol] 2018 Nov; Vol. 5 (11), pp. e563-e598. Date of Electronic Publication: 2018 Jun 18.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Research Design*
Safety*
Hematologic Neoplasms/*therapy
Clinical Trials as Topic ; Humans
Czasopismo naukowe
Tytuł :
EMA Review of Daratumumab for the Treatment of Adult Patients with Multiple Myeloma.
Autorzy :
Tzogani K; European Medicines Agency, London, United Kingdom kyriaki.tzogani@ema.europa.eu.
Penninga E; Danish Medicines Agency, Copenhagen, Denmark.
Schougaard Christiansen ML; Danish Medicines Agency, Copenhagen, Denmark.
Hovgaard D; Danish Medicines Agency, Copenhagen, Denmark.
Sarac SB; Danish Medicines Agency, Copenhagen, Denmark.
Camarero Jimenez J; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
Garcia I; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
Lafuente M; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
Sancho-López A; Instituto de Investigación Hospital Puerta de Hierro Majadahonda, Madrid, Spain.
Salmonson T; Läkemedelsverket, Medicinal Products Agency, Uppsala, Sweden.
Gisselbrecht C; Hospital Saint Louis, Paris, France.
Pignatti F; European Medicines Agency, London, United Kingdom.
Pokaż więcej
Źródło :
The oncologist [Oncologist] 2018 May; Vol. 23 (5), pp. 594-602. Date of Electronic Publication: 2018 Jan 25.
Typ publikacji :
Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial
MeSH Terms :
Antibodies, Monoclonal/*therapeutic use
Antineoplastic Agents/*therapeutic use
Multiple Myeloma/*drug therapy
Antibodies, Monoclonal/pharmacology ; Antineoplastic Agents/pharmacology ; Double-Blind Method ; Female ; Humans ; Male ; Multiple Myeloma/pathology
Czasopismo naukowe
Tytuł :
The European Medicines Agency Review of Carfilzomib for the Treatment of Adult Patients with Multiple Myeloma Who Have Received at Least One Prior Therapy.
Autorzy :
Tzogani K; European Medicines Agency, London, United Kingdom kyriaki.tzogani@ema.europa.eu.
Camarero Jiménez J; European Medicines Agency, London, United Kingdom.; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
Garcia I; European Medicines Agency, London, United Kingdom.; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
Sancho-López A; European Medicines Agency, London, United Kingdom.; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
Martin M; European Medicines Agency, London, United Kingdom.; French National Agency for Medicines and Health Products Safety, Saint-Denis Cedex, France.
Moreau A; European Medicines Agency, London, United Kingdom.; French National Agency for Medicines and Health Products Safety, Saint-Denis Cedex, France.
Demolis P; European Medicines Agency, London, United Kingdom.; French National Agency for Medicines and Health Products Safety, Saint-Denis Cedex, France.
Salmonson T; European Medicines Agency, London, United Kingdom.; Läkemedelsverket, Medicinal Products Agency, Uppsala, Sweden.
Bergh J; European Medicines Agency, London, United Kingdom.; Karolinska Institutet, Stockholm, Sweden.
Laane E; European Medicines Agency, London, United Kingdom.; North Estonia Regional Hospital, Tallinn, Estonia.
Ludwig H; European Medicines Agency, London, United Kingdom.; Wilhelminen Cancer Research Institute, Vienna, Austria.
Gisselbrecht C; European Medicines Agency, London, United Kingdom.; Hospital Saint Louis, Paris, France.
Pignatti F; European Medicines Agency, London, United Kingdom.
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Źródło :
The oncologist [Oncologist] 2017 Nov; Vol. 22 (11), pp. 1339-1346. Date of Electronic Publication: 2017 Sep 21.
Typ publikacji :
Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial
MeSH Terms :
Antineoplastic Combined Chemotherapy Protocols/*administration & dosage
Multiple Myeloma/*drug therapy
Neoplasm Recurrence, Local/*drug therapy
Oligopeptides/*administration & dosage
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Dexamethasone/administration & dosage ; Dexamethasone/adverse effects ; Disease Progression ; Disease-Free Survival ; Drug-Related Side Effects and Adverse Reactions/classification ; Drug-Related Side Effects and Adverse Reactions/pathology ; Europe/epidemiology ; Female ; Humans ; Lenalidomide ; Male ; Middle Aged ; Multiple Myeloma/epidemiology ; Multiple Myeloma/pathology ; Neoplasm Recurrence, Local/pathology ; Oligopeptides/adverse effects ; Thalidomide/administration & dosage ; Thalidomide/adverse effects ; Thalidomide/analogs & derivatives
Czasopismo naukowe
Tytuł :
European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer.
Autorzy :
Stanel SC; European Medicines Agency, London, UK.
Sjöberg J; Läkemedelsverket, Medical Products Agency, Uppsala, Sweden.
Salmonson T; Läkemedelsverket, Medical Products Agency, Uppsala, Sweden.
Foggi P; Agenzia Italiana del Farmaco, Italian Medicines Agency, Rome, Italy.
Caleno M; Agenzia Italiana del Farmaco, Italian Medicines Agency, Rome, Italy.
Melchiorri D; Department of Physiology and Pharmacology, University of Roma 'La Sapienza', Rome, Italy.
Gravanis I; European Medicines Agency, London, UK.
Tzogani K; European Medicines Agency, London, UK.
Pignatti F; European Medicines Agency, London, UK.
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Źródło :
ESMO open [ESMO Open] 2017 May 02; Vol. 2 (2), pp. e000190. Date of Electronic Publication: 2017 May 02 (Print Publication: 2017).
Typ publikacji :
Journal Article; Review
Czasopismo naukowe
Tytuł :
The European Medicines Agency Review of Brentuximab Vedotin (Adcetris) for the Treatment of Adult Patients With Relapsed or Refractory CD30+ Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use.
Autorzy :
Gravanis I; European Medicines Agency, London, United Kingdom .
Tzogani K; European Medicines Agency, London, United Kingdom.
van Hennik P; European Medicines Agency, London, United Kingdom Medicines Evaluation Board, Utrecht, The Netherlands.
de Graeff P; European Medicines Agency, London, United Kingdom Medicines Evaluation Board, Utrecht, The Netherlands.
Schmitt P; European Medicines Agency, London, United Kingdom Paul-Ehrlich-Institut, Langen, Germany.
Mueller-Berghaus J; European Medicines Agency, London, United Kingdom Paul-Ehrlich-Institut, Langen, Germany.
Salmonson T; European Medicines Agency, London, United Kingdom Läkemedelsverket, Medical Products Agency, Uppsala, Sweden.
Gisselbrecht C; European Medicines Agency, London, United Kingdom Hôpital Saint Louis, Paris, France.
Laane E; European Medicines Agency, London, United Kingdom North Estonia Regional Hospital, Tallinn, Estonia.
Bergmann L; European Medicines Agency, London, United Kingdom Universitätsklinikum, J.W. Goethe University, Frankfurt, Germany.
Pignatti F; European Medicines Agency, London, United Kingdom.
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Źródło :
The oncologist [Oncologist] 2016 Jan; Vol. 21 (1), pp. 102-9. Date of Electronic Publication: 2015 Nov 30.
Typ publikacji :
Journal Article
MeSH Terms :
Antineoplastic Agents/*administration & dosage
Hodgkin Disease/*drug therapy
Immunoconjugates/*administration & dosage
Lymphoma, Large-Cell, Anaplastic/*drug therapy
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents/adverse effects ; Brentuximab Vedotin ; Child ; Europe ; Female ; Government Agencies ; Hodgkin Disease/diagnosis ; Hodgkin Disease/pathology ; Humans ; Immunoconjugates/adverse effects ; Ki-1 Antigen/genetics ; Lymphoma, Large-Cell, Anaplastic/diagnosis ; Lymphoma, Large-Cell, Anaplastic/pathology ; Male ; Middle Aged ; Remission Induction
Czasopismo naukowe

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