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European Medicines Agency
List of ebooks and manuals about European Medicines Agency
46 documents available in our comprehensive collection of European Medicines Agency resources. Find practical guides, tutorials, and documentation to enhance your knowledge.
European Medicines Agency's database (novorapid-epar-product-information_en.pdf)
976 KBEN 122 pages
NovoRapid is a rapid-acting insulin analogue for treatment of diabetes mellitus in adults, adolescents, and children aged 1 year and above.
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,
List item CHMP summary of opinion for Coagadex (PDF/75.08 KB) AdoptedFirst published: 29/01/2016 Last updated: 29/01/2016 EMA/CH (chmp-summary-opinion-coagadex_en.pdf)
75 KBEN 1 page
The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion on January 28, 2016, recommending marketing
EMA Approves Strensiq for Rare Bone Disorder: Positive CHMP Opinion for Enzyme Replacement Therapy (chmp-summary-positive-opinion-strensiq_en.pdf)
69 KBEN 1 page
The European Medicines Agency's Committee for Medicinal Products recommended granting initial authorisation for Strensiq, an orphan drug treating paediatric-onset hypophosphatasia, manufactured by Alexion Europe SAS
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
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 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
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 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
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
List item Agenda - PDCO agenda of the 18-21 April 2017 meeting (PDF/244.82 KB) DraftFirst published: 19/04/2017 Last updated: 19 (agenda-pdco-agenda-18-21-april-2017-meeting_en.pdf)
244 KBEN 32 pages
The European Medicines Agency's Paediatric Committee (PDCO) meeting was scheduled for 18-21 April 2017
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
Portuguese (pirsue-epar-summary-public_pt.pdf)
81 KBEN 1 page
The European Medicines Agency is located at Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands, and can be contacted at +31 (0)88 781 6000 or through
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
Spanish (entyvio-epar-summary-public_es.pdf)
129 KBEN 3 pages
Entyvio (vedolizumab) is a medicine used to treat adults with ulcerative colitis, Crohn's disease, or chronic pouchitis.
MODEL Corpus (ecp17131035.pdf)
230 KBEN 3 pages
The MODEL project created a multilingual open data corpus for European languages, collecting over 10 million parallel segments from various sources, including
EFPIA's Integrated Life Sciences Strategy for Europe (EFPIA-healthgrowth_MANIFESTO-SHEET_V08.pdf)
77 KBEN 2 pages
EFPIA calls for a collaborative European Life Sciences Strategy to tackle health inequalities and drive economic growth, focusing on three interconnected pillars: innovation, access, and sustainability
Erelzi Overview (erelzi-epar-medicine-overview_sv.pdf)
108 KBEN 3 pages
Erelzi (etanercept) is an anti-inflammatory medicine used to treat immune system diseases, including rheumatoid arthritis, juvenile idiopathic arthritis,...
Portuguese (zubsolv-epar-summary-public_pt.pdf)
76 KBEN 3 pages
Zubsolv is a medicine used to treat dependence on opioid drugs in adults and adolescents over 15 years.
Erelzi Overview (erelzi-epar-medicine-overview_hr.pdf)
108 KBEN 3 pages
Erelzi (etanercept) is an anti-inflammatory medicine used to treat immune system diseases, including rheumatoid arthritis, juvenile idiopathic arthritis,...
French (lyrica-epar-summary-public_fr.pdf)
62 KBEN 3 pages
Lyrica is a medicine containing pregabalin, used to treat neuropathic pain, epilepsy, and generalized anxiety disorder in adults.
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Lacosamide Accord, INN - lacosamide (lacosamide-accord-epar-summary-public_hr.pdf)
92 KBEN 3 pages
Document en en
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
Orphan Drug Designation (EMA-Public-Summary-of-opinion-on-orphan-designation-for-Cisplatin.pdf)
112 KBEN 4 pages
Cisplatin was granted orphan designation by the European Commission for the treatment of malignant mesothelioma, a life-threatening cancer affecting the
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Generic Medicines: Definition, Contents, and Development Timeline (questions-answers-generic-medicines_et.pdf)
66 KBEN 3 pages
A generic medicine is an identical copy of an existing authorized medication, with the same active substance, dose, and treatment purpose, but potentially different branding and packaging. It requires approval to demonstrate bioequivalence to the reference medicine.
Download image in PDF format (chmp-statistics-december-2017_en.pdf)
811 KBEN 1 page
December 2017
Positive opinions on extensions of therapeutic indications
Withdrawn applications
Total
New medicines: 6 (1 non-orphan, 2 orphan, 1
Ryaltris (pil.12898.pdf)
769 KBEN 7 pages
Ryaltris is a nasal spray containing mometasone furoate and olopatadine, used to treat moderate to severe seasonal and perennial allergic rhinitis in adults...
médicament Spinraza (spinraza-epar-summary-public_en.pdf)
78 KBEN 3 pages
Spinraza is a medicine used to treat 5q spinal muscular atrophy (SMA), a genetic disease that causes weakness and wasting of muscles.
Bleomycin Safety Update (202203_en.pdf)
102 KBEN 6 pages
The PRAC considers a relationship between bleomycin and acute myeloid leukaemia/myelodysplastic syndrome when used with other antineoplastic agents cannot be...
Paediatric Regulation Q&A (CMDh_007_2007_Rev11_2021_09_clean_Q_A_on_the_Paediatric_Regulation.pdf)
362 KBEN 8 pages
Articles 45 and 46 of the Paediatric Regulation apply to all medicinal products, regardless of authorization route.
Download PDF (12.81 MB) (Pub1564webNew-74666420.pdf)
12.73 MBEN 710 pages
A Handbook for Teachers and Students, published by the International Atomic Energy Agency (IAEA) in 2014, is a comprehensive guide endorsed by several
COVID-19 Vaccine Petition (Wodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_EN_unsigned_with_Exhibits.pdf)
1.63 MBEN 43 pages
Dr. Wolfgang Wodarg and Dr.
French (entresto-epar-scientific-conclusions-annex-iv_fr.pdf)
99 KBEN 5 pages
Sartan-containing medicinal products are used to treat serious conditions like hypertension and heart or kidney diseases.
Spanish (aftovaxpur-doe-epar-summary-public_es.pdf)
172 KBEN 3 pages
Aftovaxpur DOE is a vaccine used to vaccinate cattle, sheep, and pigs against foot-and-mouth disease, containing up to three strains of inactivated...
Laser Spectroscopy (Booklet-LSO.pdf)
1.34 MBEN 13 pages
Laser Spectroscopy and Optics group (LSO) competences include laser spectroscopy of milli-, micro-, and nano-droplets, microdroplet lasers, and biomedical...
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.
Latvian (gvk-biosciences-article-31-referral-annex-ii_lv.pdf)
84 KBEN 12 pages
The French Agency on medicinal products (ANSM) inspected GVK Biosciences Private Limited in India from 19-23 May 2014 and found data manipulations of
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...
"The history of vinegar and of its acetification systems" (147-160_05_Bourgeois_62_2.pdf)
4.05 MBEN 14 pages
The history of vinegar dates back to around 3000 B.C., with the Babylonians using it as a food and preserving agent.
Premsa Consejo (14/09/2016) (R2016099484.pdf)
44 KBES 2 pages
Los trastornos digestivos y los procesos nerviosos son los principales motivos por los que los pacientes recurren a medicamentos de plantas medicinales en...
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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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