European Public Assessment Reports

$179 / year

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.


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.

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John Snow Labs; European Medicines Agency (EMA);

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

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EMA European Public Assessment Reports, European Medicines Agency EPARs

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 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-
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
HumanTrepulmixHypertension, PulmonarytreprostinilTreprostinil sodiumEMEA/H/C/005207FalseAuthorisedB01AC21FalseFalseFalseFalseFalseFalseTrue2020-04-03SciPharm SàrlAntithrombotic agents,2020-01-30Treatment of adult patients with WHO Functional Class (FC) III or IV and:- inoperable chronic thromboembolic pulmonary hypertension (CTEPH), or- persistent or recurrent CTEPH after surgical treatmentto improve exercise capacity.2020-04-08
VeterinaryVerafloxpradofloxacinpradofloxacinEMEA/V/C/000159FalseAuthorisedFalseFalseFalseFalseFalseFalseFalse2011-04-12Bayer Animal Health GmbH Antibacterials for systemic use, Fluoroquinolones2020-03-318.0DogsTreatment of:wound infections caused by susceptible strains of the Staphylococcus intermedius group (including S. pseudintermedius);superficial and deep pyoderma caused by susceptible strains of the Staphylococcus intermedius group (including S. pseudintermedius);acute urinary-tract infections caused by susceptible strains of Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius);as adjunctive treatment to mechanical or surgical periodontal therapy in the treatment of severe infections of the gingiva and periodontal tissues caused by susceptible strains of anaerobic organisms, for example Porphyromonas spp. and Prevotella spp.CatsTreatment of acute infections of the upper respiratory tract caused by susceptible strains of Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).Dogs, CatsQJ01MA972018-03-272020-04-08
VeterinaryLocatim (previously Serinucoli)Locatim, oral solution for neonatal calves less than 12 hours of ageBovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesinEMEA/V/C/000041FalseAuthorisedFalseFalseFalseFalseFalseFalseFalse1999-03-29Biokema AnstaltImmunologicals for bovidae2020-03-3011.0Reduction of mortality caused by enterotoxicosis associated with E. coli F5 (K99) adhesin during the first days of life as a supplement to colostrum from the dam.Calves, neonatal less than 12 hrs of ageQI02AT012013-06-132020-04-08
VeterinaryBroadlineeprinomectin, fipronil, praziquantel, (S)-methopreneeprinomectin, fipronil, praziquantel, (S)-methopreneEMEA/V/C/002700FalseAuthorisedFalseFalseFalseFalseFalseFalseFalse2013-12-04Boehringer Ingelheim Vetmedica GmbHAntiparasitic products, insecticides and repellents, Avermectins, eprinomectin, combinations2013-10-102020-03-2010.0For cats with, or at risk from mixed infestations by cestodes, nematodes and ectoparasites. The veterinary medicinal product is exclusively indicated when all three groups are targeted at the same time.EctoparasitesTreatment and prevention of infestations by fleas (Ctenocephalides felis). Elimination of fleas within 24 hours. One treatment prevents further infestations for at least one month.Prevention of environmental flea contamination by inhibiting the development of flea immature stages (eggs, larvae and pupae) for over a month.The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).Treatment and prevention of infestations by ticks (Ixodes ricinus). Elimination of ticks within 48 hours. One treatment prevents further infestations for up to 3 weeks.Treatment of notoedric mange (Notoedres cati).CestodesTreatment of infestations with tapeworms (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis, Joyeuxiella pasqualei (adult), and Joyeuxiella fuhrmanni (adult)).NematodesTreatment of infestations with gastrointestinal nematodes (L3, L4 larvae and adults of Toxocara cati, adults of Toxascaris leonina, L4 larvae and adults of Ancylostoma tubaeforme and Ancylostoma ceylanicum, and adults of Ancylostoma brazilienze).Treatment of infestations with feline lungworms (L3 larvae, L4 larvae and adults of Aelurostrongylus abstrusus, L4 larvae and adults of Troglostrongylus brevior).Treatment of infestations with vesical worms (Capillaria plica).Prevention of heartworm disease (Dirofilaria immitis larvae) for one month.CatsQP54AA542017-06-092020-04-08
HumanOndexxyaDrug-Related Side Effects and Adverse Reactionsandexanet alfaandexanet alfaEMEA/H/C/004108FalseAuthorisedV03ABTrueFalseFalseTrueFalseFalseFalse2019-04-26Portola Netherlands B.V.All other therapeutic products2019-02-282020-04-013.0For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.2019-06-272020-04-08
VeterinaryNexgard Spectraafoxolaner / milbemycin oximeafoxolaner, milbemycin oximeEMEA/V/C/003842FalseAuthorisedFalseFalseFalseFalseFalseFalseFalse2015-01-15Boehringer Ingelheim Vetmedica GmbHEndectocides, Antiparasitic products, insecticides and repellents, milbemycin oxime, combinations2020-03-208.0For the treatment of flea and tick infestations in dogs when the concurrent prevention of heartworm disease (Dirofilaria immitis larvae), angiostrongylosis (reduction in level of immature adults (L5) and adults of Angiostrongylus vasorum), thelaziosis (adult Thelazia callipaeda) and/or treatment of gastrointestinal nematode infestations is indicated.Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for 5 weeks. Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs for 4 weeks.Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.Treatment of infestations with adult gastrointestinal nematodes of the following species: roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum, Ancylostoma braziliense and Ancylostoma ceylanicum) and whipworm (Trichuris vulpis). Treatment of demodicosis (caused by Demodex canis). Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis). Prevention of heartworm disease (Dirofilaria immitis larvae) with monthly administration. Prevention of angiostrongylosis (by reduction of the level of infection with immature adult (L5) and adult stages of Angiostrongylus vasorum) with monthly administration.Prevention of establishment of thelaziosis (adult Thelazia callipaeda eyeworm infection) with monthly administration.DogsQP54AB512017-11-302020-04-08
VeterinaryProfenderemodepside / praziquantelemodepside, praziquantelEMEA/V/C/000097FalseAuthorisedFalseFalseFalseFalseFalseFalseFalse2005-07-27Bayer Animal Health GmbHAntiparasitic products, insecticides and repellents2020-03-3118.0CatsFor cats suffering from, or at risk from, mixed parasitic infections caused by roundworms and tapeworms of the following species:Roundworms (Nematodes)Toxocara cati (mature adult, immature adult, L4 and L3);Toxocara cati (L3 larvae) – treatment of queens during late pregnancy to prevent lactogenic transmission to the offspring;Toxascaris leonina (mature adult, immature adult and L4);Ancylostoma tubaeforme (mature adult, immature adult and L4).Tapeworms (Cestodes)Dipylidium caninum (mature adult and immature adult);Taenia taeniaeformis (adult);Echinococcus multilocularis (adult).LungwormsAelurostrongylus abstrusus (adult).DogsFor dogs suffering from, or at risk from, mixed parasitic infections caused by roundworms and tapeworms of the following species:Roundworms (nematodes):Toxocara canis (mature adult, immature adult, L4 and L3);Toxascaris leonina (mature adult, immature adult and L4);Ancylostoma caninum (mature adult and immature adult);Uncinaria stenocephala (mature adult and immature adult);Trichuris vulpis (mature adult, immature adult and L4);Tapeworms (Cestodes):Dipylidium caninum;Taenia spp.;Echinococcus multilocularis (mature adult and immature);Echinococcus granulosus (mature adult and immature).Dogs, CatsQP52AA512018-03-092020-04-08
HumanCosentyxArthritis, Psoriatic, Psoriasis, Spondylitis, AnkylosingsecukinumabSecukinumabEMEA/H/C/003729FalseAuthorisedL04AC10FalseFalseFalseFalseFalseFalseFalse2015-01-14Novartis Europharm LimitedImmunosuppressants2019-10-2115.0Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.Psoriatic arthritisCosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease?modifying anti?rheumatic drug (DMARD) therapy has been inadequate.Ankylosing spondylitisCosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.2018-06-072020-04-08
HumanLyricaEpilepsy, Anxiety Disorders, NeuralgiapregabalinpregabalinEMEA/H/C/000546FalseAuthorisedN03AX16FalseFalseFalseFalseFalseFalseFalse2004-07-05Pfizer Europe MA EEIGAntiepileptics, , Other antiepileptics2020-03-2544.0Neuropathic painLyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyLyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised anxiety disorderLyrica is indicated for the treatment of generalised anxiety disorder (GAD) in adults.2017-11-162020-04-08
VeterinaryNexGardafoxolanerafoxolanerEMEA/V/C/002729FalseAuthorisedFalseFalseFalseFalseFalseFalseFalse2014-02-11Boehringer Ingelheim Vetmedica GmbHIsoxazolines, Ectoparasiticides for systemic use2013-12-112020-03-2011.0Treatment of flea infestation in dogs (Ctenocephalides felis and C. canis)  for at least 5 weeks. The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).Treatment of tick infestation in dogs (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus). One treatment kills ticks for up to one month.Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. Treatment of demodicosis (caused by Demodex canis).Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).DogsQP53BE012018-07-062020-04-08