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.
EMA Withdrawn Applications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The European Medicines Agency (EMA) Withdrawn Applications dataset includes information on the decision by a pharmaceutical company to withdraw an application made to the European Medicines Agency for a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).



Date Created | 2011 |
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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Keywords | European Medicines Agency, EMA Withdrawn, Applications Withdrawn |
Other Titles | EMA Medicinal Products Withdrawn, European Medicines Agency Withdrawn Applications |
Name | Description | Type | Constraints |
---|---|---|---|
Category | Value: Human, Veterinary | string | - |
Medicine_Name | Medicine Name | 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 |
Species | Veterinary species | 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 | 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 | Nuzyra, | omadacycline tosilate | omadacycline | Pneumonia, Bacterial, Skin Diseases, Bacterial | False | False | Paratek Ireland Limited | True | 2019-10-17 | 2019-10-18 | https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/nuzyra | ||
Human | Xyndari, | glutamine | glutamine | Anemia, Sickle Cell | False | True | Emmaus Medical Europe Ltd | True | 2019-09-18 | 2019-10-18 | https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/xyndari | ||
Human | Ekesivy, | Diclofenamide | diclofenamide | Paralyses, Familial Periodic | False | False | Sun Pharmaceutical Industries Europe B.V. | True | 2019-10-02 | 2019-10-18 | https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/ekesivy | ||
Veterinary | Coliprotec F4/F18, | Live non-pathogenic Escherichia coli O141:K94 (F18ac) and O8:K87 (F4ac) | porcine post-weaning diarrhoea vaccine (live) | False | False | Prevtec Microbia GmbH | False | 2019-05-27 | Pigs | 2019-09-18 | https://www.ema.europa.eu/en/medicines/veterinary/withdrawn-applications/coliprotec-f4f18 | ||
Human | Radicava, | edaravone | edaravone | Amyotrophic Lateral Sclerosis | False | True | Mitsubishi Tanabe Pharma GmbH | True | 2019-05-24 | 2019-05-29 | 2019-08-14 | https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/radicava | |
Human | ABP 710, | infliximab | infliximab | False | False | Amgen Europe B.V. | True | 2019-05-27 | 2019-06-28 | https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/abp-710 | |||
Human | Ambrisentan Zentiva, | ambrisentan | ambrisentan | Hypertension, Pulmonary | False | False | Zentiva, k.s. | True | 2019-04-29 | 2019-05-29 | https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/ambrisentan-zentiva | ||
Human | Canakinumab Novartis, | Canakinumab | canakinumab | Acute Coronary Syndrome, Myocardial Infarction, Stroke | False | False | Novartis Europharm Limited | True | 2018-12-04 | 2018-12-14 | 2019-05-07 | https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/canakinumab-novartis | |
Human | Efgratin, | pegfilgrastim | pegfilgrastim | Neutropenia | False | False | Gedeon Richter Plc. | True | 2018-12-20 | 2019-02-01 | 2019-04-05 | https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/efgratin-0 | |
Human | Cavoley, | pegfilgrastim | pegfilgrastim | Neutropenia | False | False | Stada Arzneimittel AG | True | 2018-12-20 | 2019-02-01 | 2019-04-05 | https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/cavoley-0 |
- EMA API Registration Certificates of EEA Sites
- EMA API Registration Certificates of Non-EEA Sites
- EMA Good Distribution Practices Certificates
- EMA Good Manufacturing Practice Certificates of EEA Countries
- EMA Good Manufacturing Practice Certificates of Non-EEA Countries
- EMA Manufacturing and Importation Authorizations
- EMA Opinions And Decisions On Paediatric Investigation Plans
- EMA Rare Disease Designations
- EMA Wholesale Distributor Authorizations
- EMA Withdrawn Applications
- European Public Assessment Reports