Works matching DE "EUROPEAN Medicines Agency"

Results: 1671

A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial<sup>1</sup>.

Published in:

Journal of Parkinson's Disease, 2021, v. 11, n. 1, p. 187, doi. 10.3233/JPD-202224

By:

Abbruzzese, Giovanni;
Kulisevsky, Jaime;
Bergmans, Bruno;
Gomez-Esteban, Juan C.;
Kägi, Georg;
Raw, Jason;
Stefani, Alessandro;
Warnecke, Tobias;
Jost, Wolfgang H.

Publication type:

Article

The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson's Disease.

Published in:

Journal of Parkinson's Disease, 2019, v. 9, n. 3, p. 553, doi. 10.3233/JPD-191648

By:

Stephenson, Diane;
Hill, Derek;
Cedarbaum, Jesse M.;
Tome, Maria;
Vamvakas, Spiros;
Romero, Klaus;
Conrado, Daniela J.;
Dexter, David T.;
Seibyl, John;
Jennings, Danna;
Nicholas, Timothy;
Matthews, Dawn;
Xie, Zhiyong;
Imam, Syed;
Maguire, Paul;
Russell, David;
Gordon, Mark Forrest;
Stebbins, Glenn T.;
Somer, Ed;
Gallagher, Jill

Publication type:

Article

EMA approved orphan medicines since the implementation of the orphan legislation.

Published in:

Orphanet Journal of Rare Diseases, 2025, v. 20, n. 1, p. 1, doi. 10.1186/s13023-025-03756-7

By:

Hahl, Eveliina;
Kurko, Terhi;
Koskinen, Hanna;
Airaksinen, Marja;
Sarnola, Kati

Publication type:

Article

A novel method for predicting the budget impact of innovative medicines: validation study for oncolytics.

Published in:

European Journal of Health Economics, 2020, v. 21, n. 6, p. 845, doi. 10.1007/s10198-020-01176-x

By:

Geenen, Joost W.;
Belitser, Svetlana V.;
Vreman, Rick A.;
van Bloois, Martijn;
Klungel, Olaf H.;
Boersma, Cornelis;
Hövels, Anke M.

Publication type:

Article

Multi-criteria decision analysis for health technology assessment: addressing methodological challenges to improve the state of the art.

Published in:

2019

By:

Oliveira, Mónica D.;
Mataloto, Inês;
Kanavos, Panos

Publication type:

journal article

EMA Priority Medicines scheme (PRIME): will more paying-for-performance agreements be needed due to immature data?

Published in:

2018

By:

Antoñanzas, F.;
Juárez-Castelló, C. A.;
Rodríguez-Ibeas, R.

Publication type:

Editorial

Measuring the efficiency of large pharmaceutical companies: an industry analysis.

Published in:

2017

By:

Gascón, Fernando;
Lozano, Jesús;
Ponte, Borja;
Fuente, David;
Gascón, Fernando;
Lozano, Jesús;
de la Fuente, David

Publication type:

journal article

Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries.

Published in:

European Journal of Health Economics, 2014, v. 15, p. 65, doi. 10.1007/s10198-014-0595-3

By:

Brodszky, Valentin;
Baji, Petra;
Balogh, Orsolya;
Péntek, Márta

Publication type:

Article

Registering New Drugs for Low-Income Countries: The African Challenge.

Published in:

PLoS Medicine, 2011, v. 8, n. 2, p. 1, doi. 10.1371/journal.pmed.1000411

By:

Moran, Mary;
Strub-Wourgaft, Nathalie;
Guzman, Javier;
Boulet, Pascale;
Wu, Lindsey;
Pecoul, Bernard

Publication type:

Article

Quality, efficacy, safety—it is not enough!

Published in:

European Journal of Clinical Pharmacology, 2021, v. 77, n. 9, p. 1425, doi. 10.1007/s00228-021-03110-3

By:

Garattini, Silvio

Publication type:

Article

Removal of the EMA orphan designation upon request of the sponsor: cui prodest?

Published in:

European Journal of Clinical Pharmacology, 2021, v. 77, n. 7, p. 1057, doi. 10.1007/s00228-021-03096-y

By:

Montanaro, Nicola;
Bonaldo, Giulia;
Motola, Domenico

Publication type:

Article

Risk Management Plans: are they a tool for improving drug safety?

Published in:

European Journal of Clinical Pharmacology, 2010, v. 66, n. 8, p. 785, doi. 10.1007/s00228-010-0848-8

By:

Frau, Serena;
Font Pous, Maria;
Luppino, Maria;
Conforti, Anita

Publication type:

Article

Superior efficacy of new medicines?

Published in:

European Journal of Clinical Pharmacology, 2010, v. 66, n. 5, p. 445, doi. 10.1007/s00228-010-0808-3

By:

Luijn, Johan;
Gribnau, Frank;
Leufkens, Hubert

Publication type:

Article

Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency.

Published in:

European Journal of Clinical Pharmacology, 2010, v. 66, n. 1, p. 39, doi. 10.1007/s00228-009-0756-y

By:

Regnstrom, Jan;
Koenig, Franz;
Aronsson, Bo;
Reimer, Tatiana;
Svendsen, Kristian;
Tsigkos, Stelios;
Flamion, Bruno;
Eichler, Hans-Georg;
Vamvakas, Spiros

Publication type:

Article

Pharmacokinetics and dosage adjustment in patients with hepatic dysfunction.

Published in:

European Journal of Clinical Pharmacology, 2008, v. 64, n. 12, p. 1147, doi. 10.1007/s00228-008-0553-z

By:

Verbeeck, Roger K.

Publication type:

Article

Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years.

Published in:

European Journal of Clinical Pharmacology, 2006, v. 62, n. 11, p. 947, doi. 10.1007/s00228-006-0193-0

By:

Ceci, A.;
Felisi, M.;
Baiardi, P.;
Bonifazi, F.;
Catapano, M.;
Giaquinto, C.;
Nicolosi, A.;
Sturkenboom, M.;
Neubert, A.;
Wong, I.

Publication type:

Article

Prevalence of Phototherapy in the Age of Biologics.

Published in:

2018

By:

Calzavara-Pinton, Piergiacomo;
Zanca, Arianna;
Arisi, Mariachiara;
Rossi, Maria Teresa;
Zane, Cristina;
Venturini, Marina;
Ortel, Bernhard;
Rossi, Maria Teresa

Publication type:

journal article

EMA finds possible links to blood clots with COVID-19 vaccines.

Published in:: Medical Laboratory Observer (MLO), 2021, v. 53, n. 6, p. 7
Publication type:: Article

Evaluation of Ema, Töllner and Rodwell scores in the diagnosis of neonatal sepsis.

Published in:

Pamukkale Medical Journal, 2024, v. 17, n. 4, p. 746, doi. 10.31362/patd.1457265

By:

Özdemir, Özmert M. A.;
Erdal, Büşra;
Turgut, Musa

Publication type:

Article

Development and Validation of an HPLC-FLD Method for the Determination of NDMA and NDEA Nitrosamines in Lisinopril Using Pre-Column Denitrosation and Derivatization Procedure.

Published in:

Separations (2297-8739), 2022, v. 9, n. 11, p. 347, doi. 10.3390/separations9110347

By:

Tsanaktsidou, Eleni;
Kanata, Lamprini;
Almpani, Sofia;
Zacharis, Constantinos K.;
Markopoulou, Catherine K.

Publication type:

Article

Development and Validation of a Sensitive HPLC Assay for Determination of Sparfloxacin According to the European Medicines Agency Guideline.

Published in:

Separations (2297-8739), 2022, v. 9, n. 8, p. 223, doi. 10.3390/separations9080223

By:

López, Cristina;
Díez, Raquel;
Rodríguez, José M.;
Sierra, Matilde;
García, Juan J.;
Fernández, Nélida;
Diez, M. José;
Sahagún, Ana M.

Publication type:

Article

Determination of Menbutone: Development and Validation of a Sensitive HPLC Assay according to the European Medicines Agency Guideline.

Published in:

Separations (2297-8739), 2022, v. 9, n. 4, p. N.PAG, doi. 10.3390/separations9040084

By:

López, Cristina;
Díez, Raquel;
Rodríguez, José M.;
Sierra, Matilde;
García, Juan J.;
Fernández, Nélida;
Diez, M. José;
Sahagún, Ana M.

Publication type:

Article

Authorization of Vaccines in the European Union.

Published in:

Molecular Frontiers Journal, 2021, v. 5, n. 1/2, p. 58, doi. 10.1142/S2529732521400034

By:

Hidalgo-Simon, Ana;
Botgros, Radu;
Cochino, Emil

Publication type:

Article

Evolution of Mesenchymal Stem Cell Therapy as an Advanced Therapeutic Medicinal Product (ATMP)—An Indian Perspective.

Published in:

Bioengineering (Basel), 2022, v. 9, n. 3, p. 111, doi. 10.3390/bioengineering9030111

By:

Muthu, Sathish;
Jeyaraman, Madhan;
Kotner, Moinuddin Basha;
Jeyaraman, Naveen;
Rajendran, Ramya Lakshmi;
Sharma, Shilpa;
Khanna, Manish;
Rajendran, Sree Naga Sowndary;
Oh, Ji Min;
Gangadaran, Prakash;
Ahn, Byeong-Cheol

Publication type:

Article

Pharmacokinetics, toxicological and clinical aspects of ulipristal acetate: insights into the mechanisms implicated in the hepatic toxicity.

Published in:

Drug Metabolism Reviews, 2021, v. 53, n. 3, p. 375, doi. 10.1080/03602532.2021.1917599

By:

Dinis-Oliveira, Ricardo Jorge

Publication type:

Article

Snake venom toxins: Potential anticancer therapeutics.

Published in:

Journal of Applied Toxicology, 2024, v. 44, n. 5, p. 666, doi. 10.1002/jat.4544

By:

Offor, Benedict C.;
Piater, Lizelle A.

Publication type:

Article

Nonclinical safety testing of imaging agents, contrast agents and radiopharmaceuticals.

Published in:

Journal of Applied Toxicology, 2021, v. 41, n. 1, p. 95, doi. 10.1002/jat.4054

By:

Baldrick, Paul

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

DPYD genotyping and dihydropyrimidine dehydrogenase (DPD) phenotyping in clinical oncology. A clinically focused minireview.

Published in:

Basic & Clinical Pharmacology & Toxicology, 2022, v. 131, n. 5, p. 325, doi. 10.1111/bcpt.13782

By:

Paulsen, Niels Herluf;
Vojdeman, Fie;
Andersen, Stig Ejdrup;
Bergmann, Troels K.;
Ewertz, Marianne;
Plomgaard, Peter;
Hansen, Morten Rix;
Esbech, Peter Skov;
Pfeiffer, Per;
Qvortrup, Camilla;
Damkier, Per

Publication type:

Article

Acute liver failure requiring transplantation: A possible link to ulipristal acetate treatment?

Published in:

Basic & Clinical Pharmacology & Toxicology, 2021, v. 129, n. 3, p. 278, doi. 10.1111/bcpt.13631

By:

Dinis‐Oliveira, Ricardo Jorge;
Vieira, Duarte Nuno

Publication type:

Article

Predictive biomarkers and clinical evidence.

Published in:

Basic & Clinical Pharmacology & Toxicology, 2021, v. 128, n. 5, p. 642, doi. 10.1111/bcpt.13578

By:

Jørgensen, Jan Trøst

Publication type:

Article

Ondansetron in pregnancy revisited: Assessment and pregnancy labelling by the European Medicines Agency (EMA) & Pharmacovigilance Risk Assessment Committee (PRAC).

Published in:

Basic & Clinical Pharmacology & Toxicology, 2021, v. 128, n. 4, p. 579, doi. 10.1111/bcpt.13541

By:

Damkier, Per;
Kaplan, Yusuf Cem;
Shechtman, Svetlana;
Diav‐Citrin, Orna;
Cassina, Matteo;
Weber‐Schoendorfer, Corinna

Publication type:

Article

β‐2 Agonists as Misusing Drugs? Assessment of both Clenbuterol‐ and Salbutamol‐related European Medicines Agency Pharmacovigilance Database Reports.

Published in:

Basic & Clinical Pharmacology & Toxicology, 2018, v. 123, n. 2, p. 182, doi. 10.1111/bcpt.12991

By:

Milano, Giulia;
Chiappini, Stefania;
Mattioli, Francesca;
Martelli, Antonietta;
Schifano, Fabrizio

Publication type:

Article

Utility of Pilot Studies for Predicting Ratios and Intrasubject Variability in High-Variability Drugs.

Published in:

Basic & Clinical Pharmacology & Toxicology, 2016, v. 119, n. 2, p. 215, doi. 10.1111/bcpt.12558

By:

Moreno, Isabel;
Ochoa, Dolores;
Román, Manuel;
Cabaleiro, Teresa;
Abad‐Santos, Francisco

Publication type:

Article

Arctium lappa and Arctium tomentosum , Sources of Arctii radix : Comparison of Anti-Lipoxygenase and Antioxidant Activity as well as the Chemical Composition of Extracts from Aerial Parts and from Roots.

Published in:

Plants (2223-7747), 2021, v. 10, n. 1, p. 78, doi. 10.3390/plants10010078

By:

Skowrońska, Weronika;
Granica, Sebastian;
Dziedzic, Magdalena;
Kurkowiak, Justyna;
Ziaja, Maria;
Bazylko, Agnieszka

Publication type:

Article

DNA-Based Authentication and Metabolomics Analysis of Medicinal Plants Samples by DNA Barcoding and Ultra-High-Performance Liquid Chromatography/Triple Quadrupole Mass Spectrometry (UHPLC-MS).

Published in:

Plants (2223-7747), 2020, v. 9, n. 11, p. 1601, doi. 10.3390/plants9111601

By:

Sánchez, Marta;
González-Burgos, Elena;
Divakar, Pradeep Kumar;
Gómez-Serranillos, M. Pilar

Publication type:

Article

Capillary leak syndrome in COVID-19 and post COVID-19 vaccines.

Published in:

2021

By:

Roncati, Luca;
Gianotti, Greta;
Ambrogi, Elisa;
Attolini, Giovanna

Publication type:

Editorial

Assessing rhinitis symptoms in children - a need for action.

Published in:

2016

By:

Wahn, Ulrich

Publication type:

Editorial

Pediatric investigation plans for specific immunotherapy: Questionable contributions to childhood health.

Published in:

Pediatric Allergy & Immunology, 2015, v. 26, n. 8, p. 695, doi. 10.1111/pai.12500

By:

Rose, Klaus;
Kopp, Matthias Volkmar

Publication type:

Article

Clinical trials in pediatric ALS: a TRICALS feasibility study.

Published in:

Amyotrophic Lateral Sclerosis & Frontotemporal Degeneration, 2022, v. 23, n. 7/8, p. 481, doi. 10.1080/21678421.2021.2024856

By:

Kliest, Tessa;
Van Eijk, Ruben P.A.;
Al-Chalabi, Ammar;
Albanese, Alberto;
Andersen, Peter M.;
Amador, Maria Del Mar;
BrÅthen, Geir;
Brunaud-Danel, Veronique;
Brylev, Lev;
Camu, William;
De Carvalho, Mamede;
Cereda, Cristina;
Cetin, Hakan;
Chaverri, Delia;
Chiò, Adriano;
Corcia, Philippe;
Couratier, Philippe;
De Marchi, Fabiola;
Desnuelle, Claude;
Van Es, Michael A.

Publication type:

Article

The Pharmacological Profile of Cyclin-dependent Kinase (CDK) 4/6 Inhibitors: Clinical Management of Toxicity and Drug Interactions Related to CDK 4/6 Inhibitor-based Treatment in Advanced/Metastatic Breast Cancer.

Published in:

Forum of Clinical Oncology, 2019, v. 10, n. 2, p. 2, doi. 10.2478/fco-2019-0007

By:

Vasiliki, Tzelepi C.;
Aristeidis, Gogadis T.;
Christos, Adamidis K.;
Timotheadou, Eleni T.

Publication type:

Article

Targeted Metabolomics: The LC-MS/MS Based Quantification of the Metabolites Involved in the Methylation Biochemical Pathways.

Published in:

Metabolites (2218-1989), 2021, v. 11, n. 7, p. 416, doi. 10.3390/metabo11070416

By:

Ntasi, Georgia;
Tsarbopoulos, Anthony;
Mikros, Emmanuel;
Gikas, Evagelos

Publication type:

Article

Spinal Muscular Atrophy after Nusinersen Therapy: Improved Physiology in Pediatric Patients with No Significant Change in Urine, Serum, and Liquor 1H-NMR Metabolomes in Comparison to an Age-Matched, Healthy Cohort.

Published in:

Metabolites (2218-1989), 2021, v. 11, n. 4, p. 206, doi. 10.3390/metabo11040206

By:

Deutsch, Leon;
Osredkar, Damjan;
Plavec, Janez;
Stres, Blaž

Publication type:

Article

Simultaneous Measurement of Tricarboxylic Acid Cycle Intermediates in Different Biological Matrices Using Liquid Chromatography–Tandem Mass Spectrometry; Quantitation and Comparison of TCA Cycle Intermediates in Human Serum, Plasma, Kasumi-1 Cell and Murine Liver Tissue

Published in:

Metabolites (2218-1989), 2020, v. 10, n. 3, p. 103, doi. 10.3390/metabo10030103

By:

Rathod, Ramji;
Gajera, Bharat;
Nazir, Kenneth;
Wallenius, Janne;
Velagapudi, Vidya

Publication type:

Article

News and Views: Update on technologies, medicines and treatments.

Published in:

Diabetic Medicine, 2019, v. 36, n. 7, p. 913, doi. 10.1111/dme.13965

By:

O'Neill, Simon

Publication type:

Article

Quinolones-Induced Musculoskeletal, Neurological, and Psychiatric ADRs: A Pharmacovigilance Study Based on Data From the Italian Spontaneous Reporting System.

Published in:

Frontiers in Pharmacology, 2020, p. 1, doi. 10.3389/fphar.2020.00428

By:

Scavone, Cristina;
Mascolo, Annamaria;
Ruggiero, Rosanna;
Sportiello, Liberata;
Rafaniello, Concetta;
Berrino, Liberato;
Capuano, Annalisa

Publication type:

Article

Ginsenoside Rg1 as an Effective Regulator of Mesenchymal Stem Cells.

Published in:

Frontiers in Pharmacology, 2020, p. 1, doi. 10.3389/fphar.2019.01565

By:

He, Fang;
Yu, Changyin;
Liu, Tao;
Jia, Huilin

Publication type:

Article

The Off-Label Use of Antineoplastics in Oncology Is Limited But Has Notable Scientific Support in a University Hospital Setting.

Published in:

Frontiers in Pharmacology, 2019, v. 10, p. 1, doi. 10.3389/fphar.2019.01210

By:

Herrero Fernandez, Marta;
Molina Villaverde, Raquel;
Arroyo Yustos, Monica;
Navarro Expósito, Fatima;
Lopez Gonzalez, Jose Luis;
Luque Infantes, Maria Rosario;
Alvarez-Mon Soto, Melchor

Publication type:

Article

Primary hyperoxaluria type 1: novel therapies at a glance.

Published in:

Clinical Kidney Journal, 2022, v. 15, p. i17, doi. 10.1093/ckj/sfab245

By:

Bacchetta, Justine;
Lieske, John C

Publication type:

Article

Primary hyperoxaluria type 1: time for prime time?

Published in:

Clinical Kidney Journal, 2022, v. 15, p. i1, doi. 10.1093/ckj/sfab233

By:

Bacchetta, Justine;
Wood, Kyle D

Publication type:

Article