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

2020-07-20

Version

2020-07-20

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-
Pharmaceutical_FormPharmaceutical form of the medicinestring-
Administration_RouteAdministration route of the medicinestring-
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 IndicationsPharmaceutical FormAdministration RouteIs Compliance CheckCompliance Check DateCompliance Procedure NumberDecision NumberAssociated NameFirst PublishedRevision DateEMA Link
Immunology-Rheumatology-TransplantationGolimumab2018-03-16PM: decision on the application for modification of an agreed PIPTreatment of ulcerative colitisSolution for injectionSubcutaneous useFalse1970-01-01 P/0065/2018Simponi Simponi2012-07-192020-06-16https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000265-pip02-11-m02
Neurology(RS)-Bacoflen, Naltrexone HCl, D-Sorbitol (PXT3003)2020-01-29PM: decision on the application for modification of an agreed PIPTreatment of Charcot-Marie-Tooth disease Type 1AOral solutionOral useFalse1970-01-01 P/0030/20202018-06-192020-06-12https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002164-pip01-17-m02
NeurologyCannabidiol2020-01-29PM: decision on the application for modification of an agreed PIPTreatment of seizures associated with Dravet Syndrome (DS), Treatment of seizures associated with infantile spasms (IS), Treatment of seizures associated with Lennox-Gastaut Syndrome (LGS), Treatment of seizures associated with Tuberous Sclerosis Complex (TSC)Oral solutionOral useFalse1970-01-01 P/0047/20202017-07-242020-06-12https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001964-pip01-16-m01
OtherVamorolone2020-01-29PM: decision on the application for modification of an agreed PIPTreatment of Duchenne muscular dystrophyOral suspensionOral useFalse1970-01-01 P/0032/20202018-06-192020-06-12https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001794-pip02-16-m02
VaccinesInfluenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)2020-01-29PM: decision on the application for modification of an agreed PIPPrevention of influenza infectionSuspension for injectionIntramuscular useFalse1970-01-01 P/0037/20372016-08-262020-06-12https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001715-pip01-14-m03
Infectious diseasesSplit influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, A/H3N2-like strain, B-like strain (Victoria lineage) and B-like strain (Yamagata lineage)2020-02-20PM: decision on the application for modification of an agreed PIPPrevention of influenza infectionSolution for injectionIntramuscular useFalse1970-01-01 P/0064/20202019-04-242020-06-12https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002359-pip01-18-m01
Pneumology-allergologyfluticasone furoate, umeclidinium bromide, vilanterol trifenatate2020-02-14RPM: decision refers to a refusal on the application for modification of an agreed PIPTreatment of asthmaInhalation powder, pre-dispensedInhalation useFalse1970-01-01 P/0058/2020Trelegy Ellipta , Temybric Ellipta , Elebrato Ellipta2018-06-192020-06-12https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002153-pip01-17-m01
OtherVosoritide (BMN 111)2020-02-10PM: decision on the application for modification of an agreed PIPTreatment of achondroplasiaPowder for solution for injectionSubcutaneous useFalse1970-01-01 P/0060/20202018-03-052020-06-12https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002033-pip01-16-m01
Oncologynivolumab2020-01-09PM: decision on the application for modification of an agreed PIPTreatment of malignant neoplasms of lymphoid tissue, Treatment of malignant neoplasms of the central nervous systemConcentrate for solution for infusionIntravenous useFalse1970-01-01 P/0026/2020Opdivo2014-04-162020-06-12https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001407-pip01-12-m02
Oncologyavapritinib2020-01-06PM: decision on the application for modification of an agreed PIPTreatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)Film-coated tablet, Age-appropriate oral solid dosage formOral useFalse1970-01-01 P/0007/20202019-04-242020-06-12https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002358-pip02-18-m01