EMA Opinions And Decisions On Paediatric Investigation Plans

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The European Medicines Agency (EMA) Opinions And Decisions On Paediatric Investigation Plans dataset includes information on opinions and decisions adopted by the European Medicines Agency’s (EMA) Paediatric Committee (PDCO) on Paediatric Investigation Plans (PIPs) including deferrals and waivers.

Complexity

Paediatric Investigation Plan (PIP) is a medicine development plan aimed at ensuring the necessary data are obtained through studies in children to support the medicine’s authorization for use in children. The plan is submitted by a pharmaceutical company to the PDCO, which is responsible for agreeing or refusing the plan and for publishing an opinion with its decision.
The Paediatric Committee (PDCO) is responsible for assessing the content of pediatric investigation plans, which describe how a medicine should be studied in children, as well as waivers and deferrals.
The PDCO adopt positive opinions for product-specific waivers, recommending that the obligation to submit data obtained through clinical studies with children be waived in all subsets of the pediatric population.

Date Created

2011

Last Modified

2018-04-21

Version

2018-04-21

Update Frequency

Irregular

Temporal Coverage

N/A

Spatial Coverage

European Economic Area Countries

Source

John Snow Labs => European Medicines Agency (EMA)

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

N/A

Keywords

European Medicines Agency, EMA Paediatric, Paediatric Investigation Plans

Other Titles

EMA Paediatric Investigation Plans, European Medicines Agency PIPS

Name Description Type Constraints
Invented_NameMedicine invented namestring-
Active_SubstanceActive substance of medicinal productstringrequired : 1
Decision_NumberPaediatric Committee (PDCO) decision numberstring-
PIP_NumberPaediatric Investigation Plan (PIP) numberstringrequired : 1
Pharmaceutical_FormsPharmaceutical form of the productstring-
Conditions_Or_IndicationsConditions or indications of the productstring-
Routes_Of_AdministrationAdministration route of the productstringrequired : 1
Decision_TypePDCO decision type codestringrequired : 1
Therapeutic_AreaProduct therapeutic areastring-
Is_Compliance_CheckPrecise if compliance check perfomedbooleanrequired : 1
Compliance_Check_DateCompliance check datedate-
Decision_DatePDCO decision datedate-
Last_UpdatedDate of last updatedaterequired : 1
Invented_NameActive_SubstanceDecision_NumberPIP_NumberPharmaceutical_FormsConditions_Or_IndicationsRoutes_Of_AdministrationDecision_TypeTherapeutic_AreaIs_Compliance_CheckCompliance_Check_DateDecision_DateLast_Updated
Glucose monohydrateP/45/2009EMEA-000221-PIP01-08Oral solutionPainOral usePPainfalse2009-03-232009-05-18
morphine / oxycodoneP/0007/2013EMEA-001281-PIP01-12Capsule, hard-Oral useWPainfalse2013-01-212013-04-03
EverolimusP/67/2008EMEA-000019-PIP03-08TabletCarcinoid tumoursOral useWOncologyfalse2008-08-152014-08-22
CladribineP/101/2009EMEA-000383-PIP01-08TabletMultiple sclerosisOral useWNeurologyfalse2009-05-192009-07-09
Cediranib maleateP/86/2010EMEA-000477-PIP01-08TabletHigh-grade gliomaOral usePOncologyfalse2010-06-012010-07-27
Paracetamol / Opium preparedP/182/2009EMEA-000514-PIP01-08Capsule, hardPainOral useWPainfalse2009-09-072009-10-22
Paracetamol / Opium preparedP/181/2009EMEA-000513-PIP01-08Capsule, hardPainOral useWPainfalse2009-09-072009-10-22
Flosfluridine tidoxilP/15/2008EMEA-000094-PIP01-07CapsuleActinic keratosisOralWDermatologyfalse2008-03-312008-04-04
IvermectinP/0298/2012EMEA-001334-PIP01-12CreamTreatment of rosaceaCutaneous useWDermatologyfalse2012-12-182013-02-11
Fentanyl citrateP/258/2009EMEA-000481-PIP01-08Nasal spray, solutionAcute painNasal useRPPainfalse2009-12-222010-01-24