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Interim Assessement Report
The EMA review was started by the Agency’s Committee for Medicinal Products for Human Use (CHMP) to support decision-making by health authorities. This first interim report includes information on seven experimental medicines intended for the treatment of people infecte...
This guideline provides advice in regards to applications for Marketing Authorisations for antimicrobial veterinary medicinal products (VMPs) on the data required and the methodology to be used for performing an assessment of the risk to public health from antimicrobial resistance (AMR) due to use o...
The second ECDC/EFSA/EMA joint report on the integrated analysis of antimicrobial consumption (AMC) and antimicrobial resistance (AMR) in bacteria from humans and food-producing animals addressed data obtained by the Agencies’ EU-wide surveillance networks for 2013–2015. AMC in both sectors, exp...
An overview of COVID-19 Vaccine AstraZeneca and why it is authorised in the EU. Available in 22 languages
18 Febr. 2021
The European Medicines Agency (EMA) is evaluating potential COVID-19 treatments and vaccines to enable promising medicines to reach patients as soon as possible. It is also interacting with medicine developers and making use of real-world data to monitor the safety and effectiveness of medicines use...
23 April 2020EMA/202483/2020 Rev
Chloroquine and hydroxychloroquine are known to potentially cause heart rhythm problems, and these could be exacerbated if treatment is combined with other medicines, such as the antibiotic azithromycin, that have similar effects on the heart.
The extensive use of antimicrobials in human and veterinary medicine in recent years has accelerated the emergence and spread of resistant microorganisms. This situation has been worsened by the lack of investment in developing new effective antibiotics. The severity of the consequences is clear to ...
Revised working paper following AVAREF meeting February 2019.
WHO has published a roadmap aiming to coordinate partners’ actions and contributions to the licensing and roll-out of Merck’s Ebola vaccine (VSV-ZEBOV) in African countries. The vaccine was developed during the West Africa Ebola epi...
Migrants in an irregular situation: access to healthcare in 10 European Union Member States
recommended
This report explores the access to healthcare granted to irregular migrants in 10 EU Member States. It focuses on migrants who are present in an irregular situation, namely those who do not fulfil conditions for entry, stay or residence. Through interviews with a range of different sources including...
The ECDC, the EFSA and the EMA have for the first time jointly explored associations between consumption of antimicrobials in humans and food-producing animals, and antimicrobial resistance in bacteria from humans and food-producing animals, using 2011 and 2012 data currently available from their re...
7 June 2021
The Africa Regulatory Taskforce is a joint effort established by the Africa Centres for Disease Control and Prevention (Africa CDC), the African Union Development Agency (AUDA-NEPAD) coordinated African Medicines Regulatory Harmonization (AMRH) Initiative, and the World Health Organisat...
Accessed: 26.11.2019
The update of the ESTC was conducted as a joint endeavour with ERS, consulting experts from international societies and organisations, national TB programmes, civil society and affected communities. The second edition of the ESTC includes 21 standards in the areas of diagnosis, treatment, HIV and co...
The Trends and Developments report presents a top-level overview of the drug phenomenon in Europe, covering drug supply, use and public health problems as well as drug policy and responses. Together with the online Statistical Bulletin and 30 Country Drug Reports, it makes up the 2019 European Drug ...
Table of contents:
- Preface
- Introductory note and acknowledgements
- Commentary
- Chapter 1: Drug supply and the market
- Chapter 2: Drug use prevalence and trends
- Chapter 3: Drug-related harms and responses
- Annex: National data tables
Available in 24 languages on:
http://www.emcdd...
Ukrainian Title:
УКРАЇНА: Еквівалентність лікарських засобів, зареєстрованих в Україні та інших країнах. Інформація для працівників охорони здоров'я та пацієнтів
To support t...
