Others titles

  • EMA European Public Assessment Reports
  • European Medicines Agency EPARs

Keywords

  • 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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John Snow Labs Standard End User License Agreement

Last updated:January 20, 2021

This Standard End User License Agreement (“EULA”) applies to customers of John Snow Labs Inc. (as defined below), using any product of John Snow Labs Inc. on John Snow Labs Marketplace as defined below (hereinafter referred to “you”) and John Snow Labs Inc., a Delaware corporation (“John Snow Labs”, “we” or “us”).

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This EULA will become effective as of the date of your order of Products and shall be in effect until terminated.

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“John Snow Labs,” the John Snow Labs logo, and any other product, business or service name or slogan, whether registered or pending, displayed on our Products are trademarks of John Snow Labs, Inc. or its suppliers or licensors, and may not be copied, imitated or used, in whole or in part, without the prior written permission of John Snow Labs or the applicable trademark holder. You may not use any metatags or any other “hidden text” utilizing “John Snow Labs” or any other name, trademark or product, business or service name of John Snow Labs without our prior written permission. In addition, the look and feel of our Products, including all page headers, custom graphics, button icons and scripts, is the service mark, trademark and/or trade dress of John Snow Labs and may not be copied, imitated or used, in whole or in part, without our prior written permission. All other trademarks, pending trademarks, registered trademarks, product names and company names or logos mentioned in our Products are the property of John Snow Labs Inc. and/or their respective owners. Reference to any products, services, processes or other information, by trade name, trademark, manufacturer, supplier, or otherwise does not constitute or imply endorsement, sponsorship, or recommendation thereof by us.

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WE AND OUR SUPPLIERS AND LICENSORS WILL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR EXEMPLARY DAMAGES, INCLUDING BUT NOT LIMITED TO, DAMAGES FOR LOSS OF PROFITS, GOODWILL, USE, DATA, OR OTHER INTANGIBLE LOSSES (EVEN IF WE HAVE BEEN ADVISED OF THE POSSIBILITY OF THESE DAMAGES), RESULTING FROM YOUR USE OF OUR PRODUCTS AND CONTENT. UNDER NO CIRCUMSTANCES WILL THE TOTAL LIABILITY OF US AND OUR SUPPLIERS AND LICENSORS OF ALL KINDS ARISING OUT OF OR RELATED TO YOUR USE OF THE PRODUCTS AND CONTENT (INCLUDING BUT NOT LIMITED TO WARRANTY CLAIMS), REGARDLESS OF THE FORUM AND REGARDLESS OF WHETHER ANY ACTION OR CLAIM IS BASED ON CONTRACT, TORT, OR OTHERWISE, EXCEED THE AMOUNTS, IF ANY, THAT YOU HAVE PAID FOR YOUR USE OF THE PRODUCTS AND CONTENT. BECAUSE SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, THE ABOVE LIMITATION MAY NOT APPLY TO YOU.

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Legal Notices

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Description

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

Data Info

Date Created

2011

Last Modified

2020-07-20

Version

2020-07-20

Update Frequency

Irregular

Temporal Coverage

N/A

Spatial Coverage

European Economic Area Countries

Source

John Snow Labs; European Medicines Agency (EMA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

European Medicines Agency, EMA Assessment Reports, Centralised Authorization Procedure, EMA Clinical DATA

Other Titles

EMA European Public Assessment Reports, European Medicines Agency EPARs

Data Fields

Name Description Type Constraints
CategoryValue: Human, Veterinarystringrequired : 1
Medicine_NameMedicine Namestringrequired : 1
Therapeutic_AreaProduct therapeutic areastring-
Common_NameProduct common namestring-
Active_SubstanceActive substance namestringrequired : 1
Product_NumberThe product numberstringrequired : 1
Is_Patient_SafetyIndicate if the product is concerned by a patient safety informationbooleanrequired : 1
Authorisation_StatusCurrent product statusstringenum : Array ( [0] => Authorised [1] => Refused [2] => Suspended [3] => Withdrawn ) required : 1
ATC_CodeAnatomical Therapeutic Chemical (ATC) codestring-
Is_Additional_MonitoringIndicate if the product is under additional monitoringbooleanrequired : 1
Is_GenericIndicate if the product is a genericbooleanrequired : 1
Is_BiosimilarIndicate if the product is a biosimilarbooleanrequired : 1
Is_Condition_ApprovalIndicate 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.booleanrequired : 1
Is_Exceptional_CircumstanceIndicate 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.booleanrequired : 1
Is_Accelerated_AssessmentIndicate 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.booleanrequired : 1
Is_OrphanIndicate 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.booleanrequired : 1
Marketing_Authorization_DateAuthorization datedate-
Refusal_DateDate of refusal of marketing authorisationdate-
Marketing_Authorization_HolderMarketing authorization holder namestring-
Human_Pharmacotherapeutic_GroupHuman pharmacotherapeutic group namestring-
Vet_Pharmacotherapeutic_GroupVeterinary pharmacotherapeutic group namestring-
Date_of_OpinionOpinion datedate-
Decision_DateDate of decisiondate-
Revision_NumberRevision numberintegerlevel : Ratio
IndicationProduct indicationstring-
SpeciesVeterinary speciesstring-
ATC_Vet_CodeAnatomical Therapeutic Chemical (ATC) veterinary codestring-
First_PublishedDate of first publicationdate-
Revision_DateDate of revisiondate-
EMA_LinkURL of the product at EMA websitestring-

Data Preview

CategoryMedicine NameTherapeutic AreaCommon NameActive SubstanceProduct NumberIs Patient SafetyAuthorisation StatusATC CodeIs Additional MonitoringIs GenericIs BiosimilarIs Condition ApprovalIs Exceptional CircumstanceIs Accelerated AssessmentIs OrphanMarketing Authorization DateRefusal DateMarketing Authorization HolderHuman Pharmacotherapeutic GroupVet Pharmacotherapeutic GroupDate of OpinionDecision DateRevision NumberIndicationSpeciesATC Vet CodeFirst PublishedRevision DateEMA Link
HumanGlyxambiDiabetes Mellitus, Type 2empagliflozin, linagliptinempagliflozin, linagliptinEMEA/H/C/003833FalseAuthorisedA10BD19FalseFalseFalseFalseFalseFalseFalse2016-11-11Boehringer Ingelheim International GmbHDrugs used in diabetes, 2016-09-152022-04-1315Glyxambi, 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.2018-08-032022-05-25https://www.ema.europa.eu/en/medicines/human/EPAR/glyxambi
HumanSynjardyDiabetes Mellitus, Type 2empagliflozin, metforminempagliflozin, metforminEMEA/H/C/003770FalseAuthorisedA10BD20FalseFalseFalseFalseFalseFalseFalse2015-05-27Boehringer IngelheimDrugs used in diabetes, 2015-03-262022-03-2424Synjardy 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. 2018-05-312022-05-25https://www.ema.europa.eu/en/medicines/human/EPAR/synjardy
HumanLysodrenAdrenal Cortex NeoplasmsmitotaneMitotaneEMEA/H/C/000521FalseAuthorisedL01XX23FalseFalseFalseFalseFalseFalseFalse2004-04-28HRA Pharma Rare DiseasesAntineoplastic agents2022-05-2517Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on non-functional adrenal cortical carcinoma is not established.2016-04-252022-05-25https://www.ema.europa.eu/en/medicines/human/EPAR/lysodren
HumanErbituxHead and Neck Neoplasms; Colorectal NeoplasmscetuximabcetuximabEMEA/H/C/000558FalseAuthorisedL01XC06FalseFalseFalseFalseFalseFalseFalse2004-06-29Merck Europe B.V. Antineoplastic agents2022-05-2529Erbitux 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.2017-06-022022-05-25https://www.ema.europa.eu/en/medicines/human/EPAR/erbitux
HumanVaxzevria (previously COVID-19 Vaccine AstraZeneca)COVID-19 virus infectionCOVID-19 Vaccine (ChAdOx1-S [recombinant])ChAdOx1-SARS-COV-2EMEA/H/C/005675TrueAuthorisedJ07BX03TrueFalseFalseTrueFalseFalseFalse2021-01-29AstraZeneca ABVaccines, 2021-01-292022-05-2021Vaxzevria 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.2021-02-182022-05-25https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca
HumanAranespAnemia; Cancer; Kidney Failure, Chronicdarbepoetin alfadarbepoetin alfaEMEA/H/C/000332FalseAuthorisedB03XA02FalseFalseFalseFalseFalseFalseFalse2001-06-08Amgen Europe B.V.Other antianemic preparations2001-05-012021-12-2244Treatment 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.2018-06-202022-05-25https://www.ema.europa.eu/en/medicines/human/EPAR/aranesp
HumanNimenrixMeningitis, Meningococcalmeningococcal groups A, C, W-135 and Y conjugate vaccineNeisseria 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 toxoidEMEA/H/C/002226FalseAuthorisedJ07AH08FalseFalseFalseFalseFalseFalseFalse2012-04-20Pfizer Europe MA EEIGVaccines, 2012-02-162022-03-3135Nimenrix 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.2018-03-152022-05-25https://www.ema.europa.eu/en/medicines/human/EPAR/nimenrix
HumanFirdapse (previously Zenas)Lambert-Eaton Myasthenic SyndromeamifampridineamifampridineEMEA/H/C/001032FalseAuthorisedN07XX05TrueFalseFalseFalseTrueFalseFalse2009-12-23SERB SAOther nervous system drugs, 2009-10-222021-07-2221Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.2018-07-132022-05-25https://www.ema.europa.eu/en/medicines/human/EPAR/firdapse
HumanVelphoroHyperphosphatemia; Renal Dialysissucroferric oxyhydroxideSucroferric oxyhydroxideEMEA/H/C/002705FalseAuthorisedV03AE05FalseFalseFalseFalseFalseFalseFalse2014-08-26Vifor Fresenius Medical Care Renal Pharma FranceDrugs for treatment of hyperkalemia and hyperphosphatemia2014-06-262022-01-119Velphoro 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 2018-02-202022-05-25https://www.ema.europa.eu/en/medicines/human/EPAR/velphoro
HumanTecfideraMultiple Sclerosisdimethyl fumaratedimethyl fumarateEMEA/H/C/002601FalseAuthorisedL04AX07FalseFalseFalseFalseFalseFalseFalse2014-01-30Biogen Netherlands B.V.Immunosuppressants2013-03-212022-05-1324Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).2017-11-092022-05-25https://www.ema.europa.eu/en/medicines/human/EPAR/tecfidera