Regulators' Advice Can Make a Difference: European Medicines Agency Approval of Zynteglo for Beta Thalassemia-Reference-Cited by-同舟云学术

Regulators' Advice Can Make a Difference: European Medicines Agency Approval of Zynteglo for Beta Thalassemia

Published:2019-11-08 Issue:3 Volume:107 Page:492-494
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Schuessler‐Lenz Martina¹,Enzmann Harald²,Vamvakas Spiros³

Affiliation:

1. European Medicines Agency (EMA) Committee for Advanced Therapies Paul‐Ehrlich‐Institut Federal Institute for Vaccines and Biomedicines Langen Germany

2. European Medicines Agency (EMA) Committee for Human Medicinal Products Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Bonn Germany

3. Product Development Scientific Support Department European Medicines Agency (EMA) Amsterdam The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1639

Reference5 articles.

1. Survival in a large cohort of Greek patients with transfusion-dependent beta thalassaemia and mortality ratios compared to the general population

2. European Medicines Agency.Advanced therapy medicinal products: overview.

3. European Medicines Agency.Adaptive pathways.

4. European Medicines Agency.PRIME: priority medicines.

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