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

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

NameDescriptionTypeConstraints
Therapeutic_AreaProduct therapeutic areastring-
Active_SubstanceActive substance of medicinal productstringrequired : 1
Decision_DatePDCO decision datedate-
Decision_TypePDCO decision type codestringrequired : 1
Conditions_Or_IndicationsConditions or indications of the productstring-
Is_Compliance_CheckPrecise if compliance check perfomedbooleanrequired : 1
Compliance_Check_DateCompliance check datedate-
Compliance_Procedure_NumberCompliance procedure numberstring-
Decision_NumberPaediatric Committee (PDCO) decision numberstring-
Associated_NameAssociated Namestring-
First_PublishedDate of first publicationdate-
Revision_DateDate of revisiondate-
EMA_LinkURL of the product at EMA websitestring-
Therapeutic_AreaActive_SubstanceDecision_DateDecision_TypeConditions_Or_IndicationsIs_Compliance_CheckCompliance_Check_DateCompliance_Procedure_NumberDecision_NumberAssociated_NameFirst_PublishedRevision_DateEMA_Link
Infectious diseasesEritoran2010-11-29PM: decision on the application for modification of an agreed PIPSepsisfalse P/272/20102011-01-102011-01-10https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/eritoran
DermatologyBriakinumab2011-01-26PM: decision on the application for modification of an agreed PIPPsoriasis vulgarisfalse P/25/20112011-02-242011-02-24https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/p252011
Painnitrous oxide2018-07-18W: decision granting a waiver in all age groups for all conditions/indicationsSedationfalse P/0217/20182018-11-28https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002340-pip01-18
PainIbuprofen2018-12-06W: decision granting a waiver in all age groups for all conditions/indicationsTreatment of painfalse P/0382/20182019-02-13https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002400-pip01-18
PainTelcagepant2011-03-03PM: decision on the application for modification of an agreed PIPMigraine with or without aurafalse P/44/20112009-06-102011-04-05https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/telcagepant
PainFentanyl citrate2009-12-22RP: decision refers to a refusal on a proposed Paediatric Investigation PlanAcute painfalse P/258/20092010-01-242010-01-24https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/fentanyl-citrate
Painmorphine, oxycodone2013-01-21W: decision granting a waiver in all age groups for all conditions/indications false P/0007/20132013-04-032013-04-03https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001281-pip01-12
NeurologyCladribine2009-05-19W: decision granting a waiver in all age groups for all conditions/indicationsMultiple Sclerosisfalse P/101/20092009-07-092009-07-09https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/cladribine
Upadacitinib2018-07-16W: decision granting a waiver in all age groups for all conditions/indicationsTreatment of vasculitidesfalse P/0187/20182018-11-27https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001741-pip05-17
PainFasinumab2018-09-11W: decision granting a waiver in all age groups for all conditions/indicationsTreatment of chronic painfalse P/0302/20182019-01-28https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002059-pip01-16