EMA Withdrawn Applications

$179 / year

The European Medicines Agency (EMA) Withdrawn Applications dataset includes information on the decision by a pharmaceutical company to withdraw an application made to the European Medicines Agency for a human medicine.
It includes withdrawals of new marketing authorization applications or for changes to existing marketing authorizations, which are evaluated by the Committee for Medicinal Products for Human Use (CHMP).

Complexity

The legal basis for the publication of information on the withdrawal of applications for marketing authorization for human medicinal products is Article 11 of Regulation EC 726/2004, which states that: “If an applicant withdraws an application for a Marketing Authorization submitted to the Agency before an opinion has been given on the application, the applicant shall communicate its reasons for doing so to the Agency.
The Agency shall make this information accessible and shall publish the assessment report, if available, after deletion of all information of commercially confidential nature”.
If an applicant withdraws an application after the CHMP has adopted a positive or negative opinion, but before the European Commission has issued a decision, the EMA will publish the relevant withdrawal documents described above, stating that the withdrawal occurred post-opinion.

Date Created

2011

Last Modified

2019-03-25

Version

2019-03-25

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European Medicines Agency, EMA Withdrawn, Applications Withdrawn

Other Titles

EMA Medicinal Products Withdrawn, European Medicines Agency Withdrawn Applications

NameDescriptionTypeConstraints
CategoryValue: Human, Veterinarystring-
Medicine_NameMedicine Namestring-
Active_SubstanceActive substance namestring-
International_Nonproprietary_Name_of_MedicineInternational nonproprietary name of medicinal product (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name.string-
Therapeutic_AreaProduct therapeutic areastring-
Is_Patient_SafetyIndicate if the product is concerned by a patient safety informationbooleanrequired : 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_HolderMarketing authorization holder namestring-
Is_Withdrawn_TypeApplication withdrawn type (true = Initial authorisation and false = Post-authorisation)boolean-
Date_Of_WithdrawalDate of application withdrawaldaterequired : 1
SpeciesVeterinary speciesstring-
First_PublishedDate of first publicationdate-
Revision_DateDate of revisiondate-
EMA_LinkURL of the product at EMA websitestring-
CategoryMedicine NameActive SubstanceInternational Nonproprietary Name of MedicineTherapeutic AreaIs Patient SafetyIs OrphanMarketing Authorization HolderIs Withdrawn TypeDate Of WithdrawalSpeciesFirst PublishedRevision DateEMA Link
HumanNuzyra,omadacycline tosilateomadacyclinePneumonia, Bacterial, Skin Diseases, BacterialFalseFalseParatek Ireland LimitedTrue2019-10-172019-10-18https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/nuzyra
HumanXyndari,glutamineglutamineAnemia, Sickle CellFalseTrueEmmaus Medical Europe LtdTrue2019-09-182019-10-18https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/xyndari
HumanEkesivy,DiclofenamidediclofenamideParalyses, Familial PeriodicFalseFalseSun Pharmaceutical Industries Europe B.V.True2019-10-022019-10-18https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/ekesivy
VeterinaryColiprotec F4/F18,Live non-pathogenic Escherichia coli O141:K94 (F18ac) and O8:K87 (F4ac)porcine post-weaning diarrhoea vaccine (live)FalseFalsePrevtec Microbia GmbHFalse2019-05-27Pigs2019-09-18https://www.ema.europa.eu/en/medicines/veterinary/withdrawn-applications/coliprotec-f4f18
HumanRadicava,edaravoneedaravoneAmyotrophic Lateral SclerosisFalseTrueMitsubishi Tanabe Pharma GmbHTrue2019-05-242019-05-292019-08-14https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/radicava
HumanABP 710,infliximabinfliximabFalseFalseAmgen Europe B.V.True2019-05-272019-06-28https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/abp-710
HumanAmbrisentan Zentiva,ambrisentanambrisentanHypertension, PulmonaryFalseFalseZentiva, k.s.True2019-04-292019-05-29https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/ambrisentan-zentiva
HumanCanakinumab Novartis,CanakinumabcanakinumabAcute Coronary Syndrome, Myocardial Infarction, StrokeFalseFalseNovartis Europharm LimitedTrue2018-12-042018-12-142019-05-07https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/canakinumab-novartis
HumanEfgratin,pegfilgrastimpegfilgrastimNeutropeniaFalseFalseGedeon Richter Plc.True2018-12-202019-02-012019-04-05https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/efgratin-0
HumanCavoley,pegfilgrastimpegfilgrastimNeutropeniaFalseFalseStada Arzneimittel AGTrue2018-12-202019-02-012019-04-05https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/cavoley-0