Committee For Medicinal Products For Human Use - Infectious Diseases

Relevant Publications

Development and validation of an UPLC-MS/MS method for the determination of irinotecan (CPT-11), SN-38 and SN-38 glucuronide in human plasma and peritoneal tumor tissue from patients with peritoneal carcinomatosis.

Issue Release: 2024

Unleashing the Power of Reliance for Post-Approval Changes: A Journey with 48 National Regulatory Authorities.

Issue Release: 2024

Requesting conflicts of interest declarations from the European Medicines Agency: 3-year follow-up status.

Issue Release: 2024

Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe.

Issue Release: 2024

Protocol for the Tallaght University Hospital Institute for Memory and Cognition-Biobank for Research in Ageing and Neurodegeneration.

Issue Release: 2023

COVID-19 impact on the decision process of the Italian Medicine Agency: a quantitative assessment.

Issue Release: 2023

Cost-effectiveness model of trastuzumab deruxtecan as second-line treatment in HER2-positive unresectable and/or metastatic breast cancer in Finland.

Issue Release: 2023

Time to reimbursement of novel anticancer drugs in Europe: a case study of seven European countries.

Issue Release: 2023

Landmark endorsement of a global registry: The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), publicly endorses World Federation of Hemophilia Gene Therapy Registry as global standard.

Issue Release: 2023

A full-document analysis of the semantic relation between European Public Assessment Reports and EMA guidelines using a BERT language model.

Issue Release: 2023

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 2 Tyrosine Kinase Inhibitors.

Issue Release: 2023

Re-evaluation of a microbiological acceptable daily intake for tylosin based on its impact on human intestinal microflora.

Issue Release: 2023

Importance of Influenza Anti-Hemagglutinin Antibodies During the SARS-CoV-2 Pandemic in the 2019/2020 Epidemic Season in Poland.

Issue Release: 2022

Olipudase Alfa: First Approval.

Issue Release: 2022

Tremelimumab: First Approval.

Issue Release: 2022

Surfactant-Free Chitosan/Cellulose Acetate Phthalate Nanoparticles: An Attempt to Solve the Needs of Captopril Administration in Paediatrics.

Issue Release: 2022

Phase 3 Randomized, Multicenter, Placebo-Controlled Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of an Adjuvanted Cell Culture-Derived, H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects.

Issue Release: 2022

Tebentafusp: First Approval.

Issue Release: 2022

Ganaxolone: First Approval.

Issue Release: 2022

Oncology Products in the European Union: An Analysis of Regulatory Approvals with a CHMP Oral Explanation.

Issue Release: 2021

What Causes Headaches in Infectious Diseases?

When Are Antimalarial Drugs Used?

What is Aedes Aegypti?

What is Quarantine?

What Are the Treatment Options for Infected Newborns?

How Can it be Prevented?

How Do Vectors Transmit Diseases?

When are Serological Tests Used?

What is Antimicrobial Resistance?

Is Colonization Harmful?

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