Works about EUROPEAN Medicines Agency

Results: 1679

Pediatric drug regulation: International perspectives.

Published in:

Pediatric Anesthesia, 2019, v. 29, n. 6, p. 572, doi. 10.1111/pan.13638

By:

Baum, Victor C.;
Bax, Ralph;
Heon, Dominique;
Yang, Zhimin;
Sakiyama, Michiyo;
Anderson, Brian

Publication type:

Article

Wither codeine?

Published in:

Pediatric Anesthesia, 2013, v. 23, n. 8, p. 677, doi. 10.1111/pan.12190

By:

Tremlett, Michael R.

Publication type:

Article

Differentiating biosimilarity and comparability in biotherapeutics.

Published in:

Clinical Rheumatology, 2016, v. 35, n. 12, p. 2877, doi. 10.1007/s10067-016-3427-2

By:

Azevedo, Valderilio;
Hassett, Brian;
Fonseca, João;
Atsumi, Tatsuya;
Coindreau, Javier;
Jacobs, Ira;
Mahgoub, Ehab;
O'Brien, Julie;
Singh, Ena;
Vicik, Steven;
Fitzpatrick, Brian

Publication type:

Article

Access to the next wave of biologic therapies (Abatacept and Tocilizumab) for the treatment of rheumatoid arthritis in England and Wales.

Published in:

Clinical Rheumatology, 2012, v. 31, n. 6, p. 1005, doi. 10.1007/s10067-011-1936-6

By:

Chiu, Yee;
Ostor, Andrew;
Hammond, Anthony;
Sokoll, Katharina;
Anderson, Marina;
Buch, Maya;
Ehrenstein, Michael;
Gordon, Patrick;
Steer, Sophia;
Bruce, Ian

Publication type:

Article

Gadolinium retention after administration of contrast agents based on linear chelators and the recommendations of the European Medicines Agency.

Published in:

2018

By:

Dekkers, Ilona A.;
Roos, Rick;
van der Molen, Aart J.

Publication type:

Editorial

Drug therapy: actuality and perspectives.

Published in:: Public Health Nutrition, 2012, v. 15, n. 8A, p. 1539, doi. 10.1017/S1368980012001632
Publication type:: Article

Delayed Type Hypersensitivity Reaction Induced By Liraglutide With Tolerance to Semaglutide.

Published in:

JCEM Case Reports, 2024, v. 2, n. 6, p. 1, doi. 10.1210/jcemcr/luae105

By:

Moreno-Borque, Ricardo;
Guhl-Millán, Guillermo;
Mera-Carreiro, Sara;
Pazos-Guerra, Mario;
Cortés-Toro, Jose Antonio;
López-Bran, Eduardo

Publication type:

Article

Comparison of COVID-19 Vaccine Approvals at the US Food and Drug Administration, European Medicines Agency, and Health Canada.

Published in:

JAMA Network Open, 2021, v. 4, n. 6, p. e2114531, doi. 10.1001/jamanetworkopen.2021.14531

By:

Lythgoe, Mark P.;
Middleton, Paul

Publication type:

Article

Avelumab use in Merkel cell carcinoma treatment.

Published in:

Nowotwory, 2022, v. 72, n. 6, p. 365, doi. 10.5603/NJO.a2022.0048

By:

Dudzisz-Śledź, Monika;
Zwierzchowska, Martyna;
Bylina, Elżbieta;
Rutkowski, Piotr;
Czarnecka, Anna M.

Publication type:

Article

Rationale for the Potential Use of Recombinant Activated Factor VII in Severe Post-Partum Hemorrhage.

Published in:

Journal of Clinical Medicine, 2024, v. 13, n. 10, p. 2928, doi. 10.3390/jcm13102928

By:

Ács, Nándor;
Korte, Wolfgang C.;
von Heymann, Christian C.;
Windyga, Jerzy;
Blatný, Jan

Publication type:

Article

Pharmacological and Benefit-Risk Profile of Once-Weekly Basal Insulin Administration (Icodec): Addressing Patients' Unmet Needs and Exploring Future Applications.

Published in:

Journal of Clinical Medicine, 2024, v. 13, n. 7, p. 2113, doi. 10.3390/jcm13072113

By:

Ingrasciotta, Ylenia;
Vitturi, Giacomo;
Trifirò, Gianluca

Publication type:

Article

CAR T-Cells for the Treatment of B-Cell Acute Lymphoblastic Leukemia.

Published in:

Journal of Clinical Medicine, 2023, v. 12, n. 21, p. 6883, doi. 10.3390/jcm12216883

By:

Saleh, Khalil;
Pasquier, Florence;
Bigenwald, Camille;
De Botton, Stéphane;
Ribrag, Vincent;
Castilla-Llorente, Cristina

Publication type:

Article

Severe Asthma and Biological Therapies: Now and the Future.

Published in:

Journal of Clinical Medicine, 2023, v. 12, n. 18, p. 5846, doi. 10.3390/jcm12185846

By:

Sardon-Prado, Olaia;
Diaz-Garcia, Carolina;
Corcuera-Elosegui, Paula;
Korta-Murua, Javier;
Valverde-Molina, Jose;
Sanchez-Solis, Manuel

Publication type:

Article

Management of High-Risk Hypercholesterolemic Patients and PCSK9 Inhibitors Reimbursement Policies: Data from a Cohort of Italian Hypercholesterolemic Outpatients.

Published in:

Journal of Clinical Medicine, 2022, v. 11, n. 16, p. 4701, doi. 10.3390/jcm11164701

By:

Fogacci, Federica;
Giovannini, Marina;
Grandi, Elisa;
Imbalzano, Egidio;
Degli Esposti, Daniela;
Borghi, Claudio;
Cicero, Arrigo F. G.

Publication type:

Article

Development of CAR T Cell Therapy in Children—A Comprehensive Overview.

Published in:

Journal of Clinical Medicine, 2022, v. 11, n. 8, p. 2158, doi. 10.3390/jcm11082158

By:

Boettcher, Michael;
Joechner, Alexander;
Li, Ziduo;
Yang, Sile Fiona;
Schlegel, Patrick

Publication type:

Article

Volanesorsen: A New Era in the Treatment of Severe Hypertriglyceridemia.

Published in:

Journal of Clinical Medicine, 2022, v. 11, n. 4, p. N.PAG, doi. 10.3390/jcm11040982

By:

Kolovou, Genovefa;
Kolovou, Vana;
Katsiki, Niki

Publication type:

Article

New-Generation Antibiotics for Treatment of Gram-Positive Infections: A Review with Focus on Endocarditis and Osteomyelitis.

Published in:

Journal of Clinical Medicine, 2021, v. 10, n. 8, p. 1743, doi. 10.3390/jcm10081743

By:

Bloem, Annemieke;
Bax, Hannelore I.;
Yusuf, Erlangga;
Verkaik, Nelianne J.

Publication type:

Article

Thrombocytopenia and Intracranial Venous Sinus Thrombosis after "COVID-19 Vaccine AstraZeneca" Exposure.

Published in:

Journal of Clinical Medicine, 2021, v. 10, n. 8, p. 1599, doi. 10.3390/jcm10081599

By:

Wolf, Marc E.;
Luz, Beate;
Niehaus, Ludwig;
Bhogal, Pervinder;
Bäzner, Hansjörg;
Henkes, Hans

Publication type:

Article

Impact of Different JAK Inhibitors and Methotrexate on Lymphocyte Proliferation and DNA Damage.

Published in:

Journal of Clinical Medicine, 2021, v. 10, n. 7, p. 1431, doi. 10.3390/jcm10071431

By:

Reddig, Annika;
Voss, Linda;
Guttek, Karina;
Roggenbuck, Dirk;
Feist, Eugen;
Reinhold, Dirk;
Takeno, Mitsuhiro

Publication type:

Article

Are Quality of Randomized Clinical Trials and ESMO-Magnitude of Clinical Benefit Scale Two Sides of the Same Coin, to Grade Recommendations for Drug Approval?

Published in:

Journal of Clinical Medicine, 2021, v. 10, n. 4, p. 746, doi. 10.3390/jcm10040746

By:

Rodriguez, Adela;
Esposito, Francis;
Oliveres, Helena;
Torres, Ferran;
Maurel, Joan;
Brown, Joshua D.

Publication type:

Article

Antisense Oligonucleotides: An Emerging Area in Drug Discovery and Development.

Published in:

Journal of Clinical Medicine, 2020, v. 9, n. 6, p. 2004, doi. 10.3390/jcm9062004

By:

Dhuri, Karishma;
Bechtold, Clara;
Quijano, Elias;
Pham, Ha;
Gupta, Anisha;
Vikram, Ajit;
Bahal, Raman

Publication type:

Article

Angiogenesis and Immunity in Renal Carcinoma: Can We Turn an Unhappy Relationship into a Happy Marriage?

Published in:

Journal of Clinical Medicine, 2020, v. 9, n. 4, p. 930, doi. 10.3390/jcm9040930

By:

Mennitto, Alessia;
Huber, Veronica;
Ratta, Raffaele;
Sepe, Pierangela;
de Braud, Filippo;
Procopio, Giuseppe;
Guadalupi, Valentina;
Claps, Mélanie;
Stellato, Marco;
Daveri, Elena;
Rivoltini, Licia;
Verzoni, Elena

Publication type:

Article

The Extended Use of Eculizumab in Pregnancy and Complement Activation–Associated Diseases Affecting Maternal, Fetal and Neonatal Kidneys—The Future Is Now?

Published in:

Journal of Clinical Medicine, 2019, p. 407, doi. 10.3390/jcm8030407

By:

Stefanovic, Vedran

Publication type:

Article

Tissue residue depletion and estimation of extralabel meat withdrawal intervals for tulathromycin in calves after pneumatic dart administration.

Published in:

Journal of Animal Science, 2019, v. 97, n. 9, p. 3714, doi. 10.1093/jas/skz231

By:

Lin, Zhoumeng;
He, Chunla;
Magstadt, Drew R;
Cooper, Vickie L;
Kleinhenz, Michael D;
Smith, Joseph S;
Gorden, Patrick J;
Wulf, Larry W;
Coetzee, Johann F

Publication type:

Article

Adverse rare events to vaccines for COVID-19: From hypersensitivity reactions to thrombosis and thrombocytopenia.

Published in:

International Reviews of Immunology, 2022, v. 41, n. 4, p. 438, doi. 10.1080/08830185.2021.1939696

By:

Novak, Natalija;
Tordesillas, Leticia;
Cabanillas, Beatriz

Publication type:

Article

Orexinergic Receptor Antagonists as a New Therapeutic Target to Overcome Limitations of Current Pharmacological Treatment of Insomnia Disorder.

Published in:

Actas Espanolas de Psiquiatria, 2024, v. 52, n. 2, p. 172, doi. 10.62641/aep.v52i2.1659

By:

Álamo, Cecilio;
Sáiz Ruiz, Jerónimo;
Zaragozá Arnáez, Cristina

Publication type:

Article

Efficacy and Safety of Semaglutide, a Glucagon-Like Peptide-1 Receptor Agonist in Real-Life: A Case Series of Patients in Maintenance Incremental Hemodialysis.

Published in:

2022

By:

De la Flor, José C.;
Lorenzo, Javier Deira;
Marschall, Alexander;
Valga, Francisco;
Vázquez, Tania Monzón;
Cícero, Elisa Ruiz

Publication type:

Case Study

Pioglitazone: Balancing risks and benefits.

Published in:

Diabetes & Primary Care, 2011, v. 13, n. 4, p. 199

By:

Kenny, Colin

Publication type:

Article

A review of mitotane in the management of adrenocortical cancer.

Published in:

Oncologist, 2024, v. 29, n. 9, p. 747, doi. 10.1093/oncolo/oyae084

By:

Rivero, Jaydira Del;
Else, Tobias;
Hallanger-Johnson, Julie;
Kiseljak-Vassiliades, Katja;
Raj, Nitya;
Reidy-Lagunes, Diane;
Srinivas, Sandy;
Gilbert, Jill;
Vaidya, Anand;
Aboujaoude, Emily;
Bancos, Irina;
Fojo, Antonio Tito

Publication type:

Article

The EMA Assessment of Asciminib for the Treatment of Adult Patients With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase Who Were Previously Treated With at Least Two Tyrosine Kinase Inhibitors.

Published in:

Oncologist, 2023, v. 28, n. 7, p. 628, doi. 10.1093/oncolo/oyad119

By:

Tesileanu, C Mircea S;
Michaleas, Sotirios;
Ruiz, Rocio Gonzalo;
Mariz, Segundo;
Fabriek, Babs O;
Hennik, Paula B van;
Dedorath, Jutta;
Dekic, Bruna;
Unkrig, Christoph;
Brandt, Andreas;
Koenig, Janet;
Enzmann, Harald;
Delgado, Julio;
Pignatti, Francesco

Publication type:

Article

EMA Review of Isatuximab in Combination with Pomalidomide and Dexamethasone for the Treatment of Adult Patients with Relapsed and Refractory Multiple Myeloma.

Published in:

Oncologist, 2021, v. 26, n. 11, p. 983, doi. 10.1002/onco.13892

By:

Delgado, Julio;
Zienowicz, Malgorzata;
van Hennik, Paula Boudewina;
Moreau, Alexandre;
Gisselbrecht, Christian;
Enzmann, Harald;
Pignatti, Francesco

Publication type:

Article

Development and Validation of a Reverse-Phase High-Performance Liquid Chromatography with Fluorescence Detection (RP-HPLC-FL) Method to Quantify Ruxolitinib in Plasma Samples.

Published in:

Analytical Letters, 2019, v. 52, n. 8, p. 1328, doi. 10.1080/00032719.2018.1537283

By:

Charlier, Bruno;
Marino, Luigi;
Dal Piaz, Fabrizio;
Pingeon, Marine;
Coglianese, Albino;
Izzo, Barbara;
Serio, Bianca;
Selleri, Carmine;
Filippelli, Amelia;
Izzo, Viviana

Publication type:

Article

Fexinidazole for Human African Trypanosomiasis, the Fruit of a Successful Public-Private Partnership.

Published in:

Diseases, 2022, v. 10, n. 4, p. 90, doi. 10.3390/diseases10040090

By:

Bernhard, Sonja;
Kaiser, Marcel;
Burri, Christian;
Mäser, Pascal

Publication type:

Article

Luspatercept: A New Tool for the Treatment of Anemia Related to β-Thalassemia, Myelodysplastic Syndromes and Primary Myelofibrosis.

Published in:

Diseases, 2022, v. 10, n. 4, p. 85, doi. 10.3390/diseases10040085

By:

Hatzimichael, Eleftheria;
Timotheatou, Despoina;
Koumpis, Epameinondas;
Benetatos, Leonidas;
Makis, Alexandros

Publication type:

Article

Cancer patients and internal medicine patients attitude towards COVID-19 vaccination in Poland.

Published in:

Advances in Clinical & Experimental Medicine, 2021, v. 30, n. 8, p. 805, doi. 10.17219/acem/138962

By:

Kufel-Grabowska, Joanna;
Bartoszkiewicz, Mikołaj;
Ramlau, Rodryg;
Litwiniuk, Maria

Publication type:

Article

Investigation on the Use of Colistin in Critically Ill Patients at A Teaching Hospital in Ho Chi Minh City.

Published in:

Indonesian Journal of Pharmacy / Majalah Farmasi Indonesia, 2022, v. 33, n. 4, p. 610

By:

Thi Lan Nhi Vu;
Tu Thien Tam Nguyen;
Nguyen Doan Trang Dang

Publication type:

Article

Pharmacokinetic bioequivalence crossover study of branded generic and innovator formulations of the cholesterol lowering agent ezetimibe.

Published in:

Clinical Pharmacology in Drug Development, 2014, v. 3, n. 3, p. 242, doi. 10.1002/cpdd.80

By:

Palmer, Jonathan L.;
Kunhihitlu, Anil;
Costantini, Andrea;
Esquivel, Florencia;
Roush, John;
Edwards, Karina;
Hill, Thomas W.K.

Publication type:

Article

From clinical trials to informing clinical decision-making: a review of patient-reported outcomes in nononcology medicines approved by the European Medicines Agency (2018–2022).

Published in:

Frontiers in Pharmacology, 2025, p. 1, doi. 10.3389/fphar.2025.1536401

By:

Sauchelli, Sarah;
Levy, Courtney;
Gnanasakthy, Ari;
Dave, Vaidehi;
Doward, Lynda;
Fitzgerald, Kristina A.;
Carson, Robyn

Publication type:

Article

The clinical assessment of studies on orphan drugs in relation to the EMA's authorization marketing decisions in Europe.

Published in:

Frontiers in Pharmacology, 2025, p. 1, doi. 10.3389/fphar.2025.1558987

By:

Jakubowski, Szczepan;
Malinowski, Krzysztof Piotr;
Kawalec, Paweł

Publication type:

Article

Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation.

Published in:

Frontiers in Pharmacology, 2017, p. 1, doi. 10.3389/fphar.2017.00497

By:

Bonanno, Patricia Vella;
Ermisch, Michael;
Godman, Brian;
Martin, Antony P.;
Van Den Bergh, Jesper;
Bezmelnitsyna, Liudmila;
Bucsics, Anna;
Arickx, Francis;
Bybau, Alexander;
Bochenek, Tomasz;
van de Casteele, Marc;
Diogene, Eduardo;
Eriksson, Irene;
Fürst, Jurij;
Gad, Mohamed;
Greičiūtė-Kuprijanov, Ieva;
van der Graaff, Martin;
Gulbinovic, Jolanta;
Jones, Jan;
Joppi, Roberta

Publication type:

Article

Multiplexed bead-based assay for the simultaneous quantification of human serum IgG antibodies to tetanus, diphtheria, pertussis toxin, filamentous hemagglutinin, and pertactin.

Published in:

Frontiers in Immunology, 2023, p. 1, doi. 10.3389/fimmu.2023.1190404

By:

Rathod, Vishal;
Kadam, Laxmikant;
Gautam, Manish;
Gumma, Prabhu Dasu;
Marke, Kevin;
Asokanathan, Cathy;
Douglas-Bardsley, Alex;
Hassell, Laura;
Bhandare, Sachin;
Gupta, Sumit;
Parekh, Sameer;
Pujari, Pramod;
Rao, Harish;
Sharma, Hitt;
Shaligram, Umesh;
Gairola, Sunil

Publication type:

Article

European Medicines Agency: Approval of new glucose‐lowering medicines for type 2 diabetes.

Published in:

Diabetes, Obesity & Metabolism, 2018, v. 20, n. 9, p. 2057, doi. 10.1111/dom.13360

By:

Bailey, Clifford J.

Publication type:

Article

The European Medicines Agency's approval of new medicines for type 2 diabetes.

Published in:

Diabetes, Obesity & Metabolism, 2018, v. 20, n. 9, p. 2059, doi. 10.1111/dom.13349

By:

Blind, Eberhard;
Janssen, Heidi;
Dunder, Kristina;
de Graeff, Pieter A.

Publication type:

Article

Do thiazolidinediones still have a role in treatment of type 2 diabetes mellitus?

Published in:

Diabetes, Obesity & Metabolism, 2013, v. 15, n. 11, p. 967, doi. 10.1111/dom.12101

By:

Consoli, A.;
Formoso, G.

Publication type:

Article

“Market withdrawals” of medicines in Germany after AMNOG: a comparison of HTA ratings and clinical guideline recommendations.

Published in:

Health Economics Review, 2018, v. 8, n. 1, p. 1, doi. 10.1186/s13561-018-0209-3

By:

Staab, Thomas R.;
Walter, Miriam;
Mariotti Nesurini, Sonja;
Dintsios, Charalabos-Markos;
Graf von der Schulenburg, J.-Matthias;
Amelung, Volker E.;
Ruof, Jörg

Publication type:

Article

Current review of isoxazoline ectoparasiticides used in veterinary medicine.

Published in:

Journal of Veterinary Pharmacology & Therapeutics, 2022, v. 45, n. 1, p. 1, doi. 10.1111/jvp.12959

By:

Zhou, Xueying;
Hohman, Alexandra E.;
Hsu, Walter H.

Publication type:

Article

Comparative pharmacokinetics of diaveridine in pigs and chickens following single intravenous and oral administration.

Published in:

Journal of Veterinary Pharmacology & Therapeutics, 2017, v. 40, n. 5, p. 500, doi. 10.1111/jvp.12384

By:

Li, Y.‐F.;
Guo, H.‐Y.;
Yang, F.;
Zhou, L.‐G.;
Huang, X.‐H.;
Ding, H.‐Z.;
Zeng, Z.‐L.

Publication type:

Article

The introduction of nitrosamine impurities in medicinal products.

Published in:

Journal of Chinese Pharmaceutical Sciences, 2023, v. 32, n. 3, p. 223, doi. 10.5246/jcps.2023.03.020

By:

Jianzhao Niu;
Dongsheng Yang;
Yufei Feng;
Baihao Sun;
Haoyue Guan;
Lingyun Ma

Publication type:

Article

Highlights from the breakout session: optimising new treatments.

Published in:

Rheumatology, 2025, v. 64, p. i117, doi. 10.1093/rheumatology/keae426

By:

Francis, Lucy;
Dhutia, Amrita;
Pusey, Charles;
Jones, Rachel B

Publication type:

Article

Evaluation of the ACR/EULAR 2022 criteria for classification of ANCA-associated vasculitis in a population-based cohort from Sweden.

Published in:

Rheumatology, 2024, v. 63, n. 7, p. 1965, doi. 10.1093/rheumatology/kead516

By:

Rathmann, Jens;
Segelmark, Mårten;
Mohammad, Aladdin J

Publication type:

Article