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European Medicines Agency Emea
List of ebooks and manuals about European Medicines Agency Emea
19 documents available in our comprehensive collection of European Medicines Agency Emea resources. Find practical guides, tutorials, and documentation to enhance your knowledge.
Dutch (laboratory-patient-journey-centrally-authorised-medicine_nl.pdf)
1.76 MBEN 26 pages
The European Medicines Agency (EMA) oversees the journey of a medicine from laboratory to patient, involving research, development, evaluation, authorisation,
https://www.ema.europa.eu/en/documents/other/questions-answers-implementation-risk-based-prevention-cross-contamination-producti (questions-answers-implementation-risk-based-prevention-cross-contamination-production-guideline_en.pdf)
147 KBEN 4 pages
The European Medicines Agency (EMA) provides guidance on implementing risk-based prevention of cross-contamination in production
Dostupné online (covid-19-vaccines-safety-update-20-january-2022_en.pdf)
251 KBEN 10 pages
The European Medicines Agency (EMA) continuously monitors the safety of authorized COVID-19 vaccines and provides regular updates
List item 2012 - First annual report on EudraVigilance for the European Parliament, the Council and the Commission (PDF/686.8 KB (2012-first-annual-report-eudravigilance-european-parliament-council-commission_en.pdf)
686 KBEN 33 pages
The European Medicines Agency (EMA) released its first annual report on EudraVigilance for 2012, covering the European Union's (EU) pharmacovigilance system
List item Lynparza-H-C-3726-X-0016-G : EPAR - Assessment Report - Extension (PDF/3.33 MB) AdoptedFirst published: 28/05/2018 Las (lynparza-h-c-3726-x-0016-g-epar-assessment-report-extension_en.pdf)
3.33 MBEN 163 pages
The European Medicines Agency (EMA) issued an assessment report on the extension of marketing authorisation for Lynparza (olaparib) on February 22, 2018
EMA/CHMP/BWP/187338/2014: Guideline on Process Validation for the Manufacture of Biotechnology-Derived Active Substances and Dat (guideline-process-validation-manufacture-biotechnology-derived-active-substances-data-be-provided_en.pdf)
181 KBEN 13 pages
The European Medicines Agency (EMA) issued a guideline on process validation for biotechnology-derived active substances, covering process characterisation and
List item Qualification opinion - C-PATH response to iBox Scoring System (Composite Biomarker Panel) - List of Issues (PDF/1.25 (qualification-opinion-c-path-response-ibox-scoring-system-composite-biomarker-panel-list-issues_en.pdf)
1.25 MBEN 14 pages
The European Medicines Agency (EMA) is evaluating the iBox Scoring System, a composite biomarker panel, as a surrogate endpoint for efficacy in clinical trials
Hungarian (omeprazole-capsules-eu_hu.pdf)
75 KBEN 2 pages
The European Medicines Agency (EMA) recommends authorisation of Diotop (diclofenac / omeprazole capsules) in the EU, concluding that its benefits outweigh its
List item Letter of support for a Model-based Clinical Trial Simulation Platform to Optimize Design of Efficacy Evaluation Studi (letter-support-model-based-clinical-trial-simulation-platform-optimize-design-efficacy-evaluation_en.pdf)
187 KBEN 4 pages
The European Medicines Agency (EMA) provides a letter of support for a model-based clinical trial simulation platform to optimize the design of efficacy
Deliverable 3.1 (April 2017) Report on feedback from EMA on design of diagnostic study (D3.1-AMYPAD.pdf)
454 KBEN 1 page
The AMYPAD project received scientific advice from the European Medicines Agency (EMA) and HTA authorities on the design of a diagnostic study, which started
List item GVK Biosciences Article-31 referral - Review started (PDF/63.67 KB) First published: 26/09/2014 Last updated: 26/09/20 (gvk-biosciences-article-31-referral-review-started_en.pdf)
63 KBEN 1 page
The European Medicines Agency (EMA) has started a review concerning the conduct of studies at GVK Biosciences site in Hyderabad, India, due to findings of
Czech (diclofenac-article-294-referral-ema-recommends-authorisation-diclofenac-sodium-spray-gel-4_cs.pdf)
77 KBEN 2 pages
The European Medicines Agency (EMA) recommends authorisation of Diclofenac Sodium Spray Gel 4% in the EU, concluding that its benefits outweigh its risks
List item EU VICH adverse event report implementation guide (PDF/1.2 MB) AdoptedFirst published: 23/11/2021 Legal effective date (eu-vich-adverse-event-report-implementation-guide_en.pdf)
1.2 MBEN 44 pages
The European Medicines Agency (EMA) has published the EU VICH adverse event report implementation guide, which provides guidance on reporting adverse events
EMA Approves Tyruko for Multiple Sclerosis Treatment (chmp-summary-positive-opinion-tyruko_en.pdf)
146 KBEN 2 pages
The European Medicines Agency (EMA) has recommended the approval of Tyruko (natalizumab) for treating multiple sclerosis, manufactured by Sandoz GmbH
Jevtana: EPAR Summary for Public Use - Cancer Treatment for Prostate Cancer (jevtana-epar-summary-public_nl.pdf)
78 KBEN 3 pages
It's an agency of the European Union, as outlined in its contact details and copyright information
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Lacosamide Accord, INN - lacosamide (lacosamide-accord-epar-summary-public_hr.pdf)
92 KBEN 3 pages
Document en en
French (jardiance-h-a20-1442-c-2677-0023-epar-scientific-conclusion-article-20_fr.pdf)
41 KBEN 4 pages
Sodium-glucose co-transporter 2 (SGLT2) inhibitors, used to treat type 2 diabetes, may increase the risk of lower limb amputations.
Maltese (adjusol-trimethoprim-sulfa-liquide-article-34-referral-annex-i-ii-iii_mt.pdf)
434 KBEN 32 pages
Annex I lists veterinary medicinal product details, including name, strength, pharmaceutical form, animal species, and route of administration, for various...
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EPAR Summary: Lacosamide Accord for Partial-Onset Seizures in Adults and Adolescents (lacosamide-accord-epar-summary-public_sv.pdf)
92 KBEN 3 pages
Lacosamide Accord is an anti-epileptic medication designed to control partial-onset seizures in patients with epilepsy. It is indicated for the treatment of this specific type of seizure, working to reduce their frequency and severity.
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