- EMA Paediatric Investigation Plans
- European Medicines Agency PIPS
- European Medicines Agency
- EMA Paediatric
- Paediatric Investigation Plans
EMA Opinions And Decisions On Paediatric Investigation Plans
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.
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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.
About this Dataset
European Economic Area Countries
John Snow Labs; European Medicines Agency (EMA);
|Source License URL|
|Source License Requirements||
European Medicines Agency, EMA Paediatric, Paediatric Investigation Plans
EMA Paediatric Investigation Plans, European Medicines Agency PIPS
|Therapeutic_Area||Product therapeutic area||string||-|
|Active_Substance||Active substance of medicinal product||string||-|
|Decision_Date||PDCO decision date||date||-|
|Decision_Type||PDCO decision type code||string||required : 1|
|Conditions_Or_Indications||Conditions or indications of the product||string||-|
|Pharmaceutical_Form||Pharmaceutical form of the medicine||string||-|
|Administration_Route||Administration route of the medicine||string||-|
|Is_Compliance_Check||Precise if compliance check perfomed||boolean||required : 1|
|Compliance_Check_Date||Compliance check date||date||-|
|Compliance_Procedure_Number||Compliance procedure number||string||-|
|Decision_Number||Paediatric Committee (PDCO) decision number||string||-|
|First_Published||Date of first publication||date||-|
|Revision_Date||Date of revision||date||-|
|EMA_Link||URL of the product at EMA website||string||-|
|Therapeutic Area||Active Substance||Decision Date||Decision Type||Conditions Or Indications||Pharmaceutical Form||Administration Route||Is Compliance Check||Compliance Check Date||Compliance Procedure Number||Decision Number||Associated Name||First Published||Revision Date||EMA Link|
|Immunology-Rheumatology-Transplantation||Golimumab||2018-03-16||PM: decision on the application for modification of an agreed PIP||Treatment of ulcerative colitis||Solution for injection||Subcutaneous use||False||1970-01-01||Â||P/0065/2018||Simponi Simponi||2012-07-19||2020-06-16||https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000265-pip02-11-m02|
|Neurology||(RS)-Bacoflen, Naltrexone HCl, D-Sorbitol (PXT3003)||2020-01-29||PM: decision on the application for modification of an agreed PIP||Treatment of Charcot-Marie-Tooth disease Type 1A||Oral solution||Oral use||False||1970-01-01||Â||P/0030/2020||2018-06-19||2020-06-12||https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002164-pip01-17-m02|
|Neurology||Cannabidiol||2020-01-29||PM: decision on the application for modification of an agreed PIP||Treatment 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 solution||Oral use||False||1970-01-01||Â||P/0047/2020||2017-07-24||2020-06-12||https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001964-pip01-16-m01|
|Other||Vamorolone||2020-01-29||PM: decision on the application for modification of an agreed PIP||Treatment of Duchenne muscular dystrophy||Oral suspension||Oral use||False||1970-01-01||Â||P/0032/2020||2018-06-19||2020-06-12||https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001794-pip02-16-m02|
|Vaccines||Influenza 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)||2020-01-29||PM: decision on the application for modification of an agreed PIP||Prevention of influenza infection||Suspension for injection||Intramuscular use||False||1970-01-01||Â||P/0037/2037||2016-08-26||2020-06-12||https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001715-pip01-14-m03|
|Infectious diseases||Split 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)||2020-02-20||PM: decision on the application for modification of an agreed PIP||Prevention of influenza infection||Solution for injection||Intramuscular use||False||1970-01-01||Â||P/0064/2020||2019-04-24||2020-06-12||https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002359-pip01-18-m01|
|Pneumology-allergology||fluticasone furoate, umeclidinium bromide, vilanterol trifenatate||2020-02-14||RPM: decision refers to a refusal on the application for modification of an agreed PIP||Treatment of asthma||Inhalation powder, pre-dispensed||Inhalation use||False||1970-01-01||Â||P/0058/2020||Trelegy Ellipta , Temybric Ellipta , Elebrato Ellipta||2018-06-19||2020-06-12||https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002153-pip01-17-m01|
|Other||Vosoritide (BMN 111)||2020-02-10||PM: decision on the application for modification of an agreed PIP||Treatment of achondroplasia||Powder for solution for injection||Subcutaneous use||False||1970-01-01||Â||P/0060/2020||2018-03-05||2020-06-12||https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002033-pip01-16-m01|
|Oncology||nivolumab||2020-01-09||PM: decision on the application for modification of an agreed PIP||Treatment of malignant neoplasms of lymphoid tissue, Treatment of malignant neoplasms of the central nervous system||Concentrate for solution for infusion||Intravenous use||False||1970-01-01||Â||P/0026/2020||Opdivo||2014-04-16||2020-06-12||https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001407-pip01-12-m02|
|Oncology||avapritinib||2020-01-06||PM: decision on the application for modification of an agreed PIP||Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)||Film-coated tablet, Age-appropriate oral solid dosage form||Oral use||False||1970-01-01||Â||P/0007/2020||2019-04-24||2020-06-12||https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002358-pip02-18-m01|