- EMA Medicinal Products Withdrawn
- European Medicines Agency Withdrawn Applications
- European Medicines Agency
- EMA Withdrawn
- Applications Withdrawn
EMA Withdrawn Applications
The European Medicines Agency (EMA) Withdrawn Applications dataset includes information on the decision by a pharmaceutical company to withdraw an application made to the European Medicines Agency for a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).
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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.
About this Dataset
European Economic Area Countries
John Snow Labs; European Medicines Agency (EMA);
|Source License URL|
|Source License Requirements||
European Medicines Agency, EMA Withdrawn, Applications Withdrawn
EMA Medicinal Products Withdrawn, European Medicines Agency Withdrawn Applications
|Category||Value: Human, Veterinary||string||-|
|Active_Substance||Active substance name||string||-|
|International_Nonproprietary_Name_of_Medicine||International 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_Area||Product therapeutic area||string||-|
|Is_Patient_Safety||Indicate if the product is concerned by a patient safety information||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|
|Marketing_Authorization_Holder||Marketing authorization holder name||string||-|
|Is_Withdrawn_Type||Application withdrawn type (true = Initial authorisation and false = Post-authorisation)||boolean||-|
|Date_Of_Withdrawal||Date of application withdrawal||date||required : 1|
|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||Active Substance||International Nonproprietary Name of Medicine||Therapeutic Area||Is Patient Safety||Is Orphan||Marketing Authorization Holder||Is Withdrawn Type||Date Of Withdrawal||Species||First Published||Revision Date||EMA Link|
|Human||Neffy||epinephrine||epinephrine||Hypersensitivity; Anaphylaxis||False||False||Ars Pharmaceuticals Irl Limited||True||2022-04-04||2022-04-22||2022-05-20||https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/neffy|
|Human||HemAryo||eptacog alfa (activated)||eptacog alfa (activated)||Hemophilia A; Hemophilia B; Factor VII Deficiency||False||False||UGA Biopharma||True||2022-05-06||2022-05-20||https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/hemaryo|
|Human||Sitoiganap||allogeneic glioma tumor cell lysates (inactivated), allogeneic glioma tumor cells (inactivated), autologous glioma tumor cell lysates (inactivated), autologous glioma tumor cells (inactivated)||autologous glioma tumor cell lysates (inactivated), allogeneic glioma tumor cell lysates (inactivated), allogeneic glioma tumor cells (inactivated), autologous glioma tumor cells (inactivated)||Glioma; Gliosarcoma; Glioblastoma||False||False||Epitopoietic Research Corporation-Belgium (E.R.C.)||True||2022-05-02||2022-05-20||https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/sitoiganap|
|Human||Miplyffa||arimoclomol citrate||arimoclomol||Niemann-Pick Disease, Type C||False||True||Orphazyme A/S||True||2022-03-22||2022-04-22||https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/miplyffa|
|Human||Aduhelm||aducanumab||aducanumab||Alzheimer Disease||False||False||Biogen Netherlands B.V.||True||2022-04-20||2022-04-22||https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/aduhelm|
|Human||Zektayos - Hepjuvo||Obeticholic acid||obeticholic acid||Fatty Liver||False||False||Intercept Pharma International Ltd||True||2021-12-09||2021-12-17||2022-04-08||https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/zektayos-hepjuvo|
|Human||Brilique||ticagrelor||ticagrelor||Peripheral Vascular Diseases; Acute Coronary Syndrome||False||False||AstraZeneca AB||False||2021-12-15||2022-01-28||2022-04-01||https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/brilique-0|
|Veterinary||Bravecto||fluralaner||fluralaner||False||False||Intervet International B.V||False||2021-08-03||Dogs; Cats||2022-03-29||https://www.ema.europa.eu/en/medicines/veterinary/withdrawn-applications/bravecto|
|Human||Dimherity||dimethyl fumarate||dimethyl fumarate||Multiple Sclerosis, Relapsing-Remitting||False||False||Sandoz GmbH||True||2022-03-24||2022-03-25||https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/dimherity|
|Human||Abylqis||arachis hypogaea extract||arachis hypogaea extract||Peanut Hypersensitivity||False||False||DBV Technologies||True||2021-12-17||2022-01-28||https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/abylqis|