- EMA European Public Assessment Reports
- European Medicines Agency EPARs
- European Medicines Agency
- EMA Assessment Reports
- Centralised Authorization Procedure
- EMA Clinical DATA
European Public Assessment Reports
The European Medicines Agency (EMA) publishes a European Public Assessment Report (EPAR) for every medicine granted a central marketing authorisation by the European Commission following an assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
EPARs are full scientific assessment reports of medicines authorized at a European Union level.
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A European public assessment report (EPAR) is published for every human or veterinary medicine application that has been granted or refused a marketing authorization. This follows an assessment by the EMA of an application submitted by a pharmaceutical company in the framework of the Central authorization of medicines.
An EPAR provides public information on a medicine, including how it was assessed by the EMA.
The EPAR is referred to in Article 13(3) of Regulation (EC) No 726/2004, which requires the EMA to publish a public assessment report for each centrally authorized medicine together with a public-friendly summary.
The EMA has developed the EPAR concept over time to ensure that it delivers a usable, transparent and appropriately detailed body of information. The EPAR content and structure have therefore evolved over time and may be further developed in future.
An important role of the EPAR is to reflect the scientific conclusions of the relevant EMA committee at the end of the assessment process, providing the grounds for the committee opinion on whether or not to approve an application.
Under the centralized authorization procedure, pharmaceutical companies submit a single marketing-authorization application to EMA. This allows the marketing-authorization holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorization.
EMA’s Committee for Medicinal products for Human Use (CHMP) or Committee for Medicinal products for Veterinary Use (CVMP) carry out a scientific assessment of the application and give a recommendation on whether the medicine should be marketed or no.
An orphan designation allows a pharmaceutical company to benefit from incentives from the European Union to develop a medicine for a rare disease, such as reduced fees and protection from competition once the medicine is placed on the market. Applications for orphan designation are examined by the COMP, which adopts an opinion that is forwarded to the European Commission. The European Commission then decides whether to grant an orphan designation for the medicine in question.
About this Dataset
European Economic Area Countries
John Snow Labs; European Medicines Agency (EMA);
|Source License URL|
|Source License Requirements||
European Medicines Agency, EMA Assessment Reports, Centralised Authorization Procedure, EMA Clinical DATA
EMA European Public Assessment Reports, European Medicines Agency EPARs
|Category||Value: Human, Veterinary||string||required : 1|
|Medicine_Name||Medicine Name||string||required : 1|
|Therapeutic_Area||Product therapeutic area||string||-|
|Common_Name||Product common name||string||-|
|Active_Substance||Active substance name||string||required : 1|
|Product_Number||The product number||string||required : 1|
|Is_Patient_Safety||Indicate if the product is concerned by a patient safety information||boolean||required : 1|
|Authorisation_Status||Current product status||string||enum : Array (  => Authorised  => Refused  => Suspended  => Withdrawn ) required : 1|
|ATC_Code||Anatomical Therapeutic Chemical (ATC) code||string||-|
|Is_Additional_Monitoring||Indicate if the product is under additional monitoring||boolean||required : 1|
|Is_Generic||Indicate if the product is a generic||boolean||required : 1|
|Is_Biosimilar||Indicate if the product is a biosimilar||boolean||required : 1|
|Is_Condition_Approval||Indicate if the product is approved under specific conditions. Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.||boolean||required : 1|
|Is_Exceptional_Circumstance||Indicate if there were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.||boolean||required : 1|
|Is_Accelerated_Assessment||Indicate this medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210.||boolean||required : 1|
|Is_Orphan||Indicate if the product has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.||boolean||required : 1|
|Refusal_Date||Date of refusal of marketing authorisation||date||-|
|Marketing_Authorization_Holder||Marketing authorization holder name||string||-|
|Human_Pharmacotherapeutic_Group||Human pharmacotherapeutic group name||string||-|
|Vet_Pharmacotherapeutic_Group||Veterinary pharmacotherapeutic group name||string||-|
|Decision_Date||Date of decision||date||-|
|Revision_Number||Revision number||integer||level : Ratio|
|ATC_Vet_Code||Anatomical Therapeutic Chemical (ATC) veterinary code||string||-|
|First_Published||Date of first publication||date||-|
|Revision_Date||Date of revision||date||-|
|EMA_Link||URL of the product at EMA website||string||-|
|Category||Medicine Name||Therapeutic Area||Common Name||Active Substance||Product Number||Is Patient Safety||Authorisation Status||ATC Code||Is Additional Monitoring||Is Generic||Is Biosimilar||Is Condition Approval||Is Exceptional Circumstance||Is Accelerated Assessment||Is Orphan||Marketing Authorization Date||Refusal Date||Marketing Authorization Holder||Human Pharmacotherapeutic Group||Vet Pharmacotherapeutic Group||Date of Opinion||Decision Date||Revision Number||Indication||Species||ATC Vet Code||First Published||Revision Date||EMA Link|
|Human||Glyxambi||Diabetes Mellitus, Type 2||empagliflozin, linagliptin||empagliflozin, linagliptin||EMEA/H/C/003833||False||Authorised||A10BD19||False||False||False||False||False||False||False||2016-11-11||Boehringer Ingelheim International GmbH||Drugs used in diabetes,||2016-09-15||2022-04-13||15||Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control;when already being treated with the free combination of empagliflozin and linagliptin.||2018-08-03||2022-05-25||https://www.ema.europa.eu/en/medicines/human/EPAR/glyxambi|
|Human||Synjardy||Diabetes Mellitus, Type 2||empagliflozin, metformin||empagliflozin, metformin||EMEA/H/C/003770||False||Authorised||A10BD20||False||False||False||False||False||False||False||2015-05-27||Boehringer Ingelheim||Drugs used in diabetes,||2015-03-26||2022-03-24||24||Synjardy is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients inadequately controlled on their maximally tolerated dose of metformin alone;in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin;in patients already being treated with the combination of empagliflozin and metformin as separate tablets.||2018-05-31||2022-05-25||https://www.ema.europa.eu/en/medicines/human/EPAR/synjardy|
|Human||Lysodren||Adrenal Cortex Neoplasms||mitotane||Mitotane||EMEA/H/C/000521||False||Authorised||L01XX23||False||False||False||False||False||False||False||2004-04-28||HRA Pharma Rare Diseases||Antineoplastic agents||2022-05-25||17||Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on non-functional adrenal cortical carcinoma is not established.||2016-04-25||2022-05-25||https://www.ema.europa.eu/en/medicines/human/EPAR/lysodren|
|Human||Erbitux||Head and Neck Neoplasms; Colorectal Neoplasms||cetuximab||cetuximab||EMEA/H/C/000558||False||Authorised||L01XC06||False||False||False||False||False||False||False||2004-06-29||Merck Europe B.V.||Antineoplastic agents||2022-05-25||29||Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer:in combination with irinotecan-based chemotherapy;in first-line in combination with FOLFOX;as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.For details, see section 5.1.Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck:in combination with radiation therapy for locally advanced disease;in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.||2017-06-02||2022-05-25||https://www.ema.europa.eu/en/medicines/human/EPAR/erbitux|
|Human||Vaxzevria (previously COVID-19 Vaccine AstraZeneca)||COVID-19 virus infection||COVID-19 Vaccine (ChAdOx1-S [recombinant])||ChAdOx1-SARS-COV-2||EMEA/H/C/005675||True||Authorised||J07BX03||True||False||False||True||False||False||False||2021-01-29||AstraZeneca AB||Vaccines,||2021-01-29||2022-05-20||21||Vaxzevria is indicated for active immunisation to prevent COVID 19 caused by SARS CoV 2, in individuals 18 years of age and older.The use of this vaccine should be in accordance with official recommendations.||2021-02-18||2022-05-25||https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca|
|Human||Aranesp||Anemia; Cancer; Kidney Failure, Chronic||darbepoetin alfa||darbepoetin alfa||EMEA/H/C/000332||False||Authorised||B03XA02||False||False||False||False||False||False||False||2001-06-08||Amgen Europe B.V.||Other antianemic preparations||2001-05-01||2021-12-22||44||Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients.Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.||2018-06-20||2022-05-25||https://www.ema.europa.eu/en/medicines/human/EPAR/aranesp|
|Human||Nimenrix||Meningitis, Meningococcal||meningococcal groups A, C, W-135 and Y conjugate vaccine||Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid||EMEA/H/C/002226||False||Authorised||J07AH08||False||False||False||False||False||False||False||2012-04-20||Pfizer Europe MA EEIG||Vaccines,||2012-02-16||2022-03-31||35||Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135, and Y.||2018-03-15||2022-05-25||https://www.ema.europa.eu/en/medicines/human/EPAR/nimenrix|
|Human||Firdapse (previously Zenas)||Lambert-Eaton Myasthenic Syndrome||amifampridine||amifampridine||EMEA/H/C/001032||False||Authorised||N07XX05||True||False||False||False||True||False||False||2009-12-23||SERB SA||Other nervous system drugs,||2009-10-22||2021-07-22||21||Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.||2018-07-13||2022-05-25||https://www.ema.europa.eu/en/medicines/human/EPAR/firdapse|
|Human||Velphoro||Hyperphosphatemia; Renal Dialysis||sucroferric oxyhydroxide||Sucroferric oxyhydroxide||EMEA/H/C/002705||False||Authorised||V03AE05||False||False||False||False||False||False||False||2014-08-26||Vifor Fresenius Medical Care Renal Pharma France||Drugs for treatment of hyperkalemia and hyperphosphatemia||2014-06-26||2022-01-11||9||Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD).Velphoro is indicated for the control of serum phosphorus levels in paediatric patients 2 years of age and older with CKD stages 4-5 (defined by a glomerular filtration rate||2018-02-20||2022-05-25||https://www.ema.europa.eu/en/medicines/human/EPAR/velphoro|
|Human||Tecfidera||Multiple Sclerosis||dimethyl fumarate||dimethyl fumarate||EMEA/H/C/002601||False||Authorised||L04AX07||False||False||False||False||False||False||False||2014-01-30||Biogen Netherlands B.V.||Immunosuppressants||2013-03-21||2022-05-13||24||Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).||2017-11-09||2022-05-25||https://www.ema.europa.eu/en/medicines/human/EPAR/tecfidera|