Others titles

  • EMA Medicinal Products Withdrawn
  • European Medicines Agency Withdrawn Applications

Keywords

  • 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  • EMA Withdrawn
  • Applications Withdrawn

EMA Withdrawn Applications

The European Medicines Agency (EMA) Withdrawn Applications dataset includes information on the decision by a pharmaceutical company to withdraw an application made to the European Medicines Agency for a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

Enforcement of this EULA will be governed by the laws of the State of Delaware, excluding its conflict and choice of law principles. The exclusive jurisdiction and venue for any claims arising out of or related to this EULA or your use of the Products will lie in the state and federal courts located in Sussex County, within the State of Delaware, and you irrevocably agree to submit to the jurisdiction of such courts. Our failure to enforce any right or provision in this EULA will not constitute a waiver of such right or provision unless acknowledged and agreed by us in writing. In the event that a court of competent jurisdiction finds any provision of this EULA to be illegal, invalid, or unenforceable, the remaining provisions will remain in full force and effect.

Notifications

We may use your contact information to notify you if we have any legitimate interest or if we need to notify you on any important information related to your use of Products. We will not send you newsletters unless you expressly consented to such notifications.

Contacting Us

If you have any questions or concerns about our Products or this EULA, you may contact us by email at support@JohnSnowLabs.com.

Description

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

Data Info

Date Created

2011

Last Modified

2022-05-26

Version

2022-05-26

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

Data Fields

Name Description Type Constraints
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-

Data Preview

CategoryMedicine NameActive SubstanceInternational Nonproprietary Name of MedicineTherapeutic AreaIs Patient SafetyIs OrphanMarketing Authorization HolderIs Withdrawn TypeDate Of WithdrawalSpeciesFirst PublishedRevision DateEMA Link
HumanNeffy epinephrineepinephrineHypersensitivity; AnaphylaxisFalseFalseArs Pharmaceuticals Irl LimitedTrue2022-04-042022-04-222022-05-20https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/neffy
HumanHemAryo eptacog alfa (activated)eptacog alfa (activated)Hemophilia A; Hemophilia B; Factor VII DeficiencyFalseFalseUGA BiopharmaTrue2022-05-062022-05-20https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/hemaryo
HumanSitoiganap 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; GlioblastomaFalseFalseEpitopoietic Research Corporation-Belgium (E.R.C.)True2022-05-022022-05-20https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/sitoiganap
HumanMiplyffa arimoclomol citratearimoclomolNiemann-Pick Disease, Type CFalseTrueOrphazyme A/STrue2022-03-222022-04-22https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/miplyffa
HumanAduhelm aducanumabaducanumabAlzheimer DiseaseFalseFalseBiogen Netherlands B.V.True2022-04-202022-04-22https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/aduhelm
HumanZektayos - Hepjuvo Obeticholic acidobeticholic acidFatty LiverFalseFalseIntercept Pharma International LtdTrue2021-12-092021-12-172022-04-08https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/zektayos-hepjuvo
HumanBrilique ticagrelorticagrelorPeripheral Vascular Diseases; Acute Coronary SyndromeFalseFalseAstraZeneca ABFalse2021-12-152022-01-282022-04-01https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/brilique-0
VeterinaryBravecto fluralanerfluralanerFalseFalseIntervet International B.VFalse2021-08-03Dogs; Cats2022-03-29https://www.ema.europa.eu/en/medicines/veterinary/withdrawn-applications/bravecto
HumanDimherity dimethyl fumaratedimethyl fumarateMultiple Sclerosis, Relapsing-RemittingFalseFalseSandoz GmbHTrue2022-03-242022-03-25https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/dimherity
HumanAbylqis arachis hypogaea extractarachis hypogaea extractPeanut HypersensitivityFalseFalseDBV TechnologiesTrue2021-12-172022-01-28https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/abylqis