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75 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Summaries of opinion Remove Summaries of opinion filter
Medicine type
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PIP decision type
PM: decision on the application for modification of an agreed PIP Remove PM: decision on the application for modification of an agreed PIP filter
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Remove P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter
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Opinion/decision on a Paediatric investigation plan (PIP): Mvabea, Multivalent, live, recombinant, non-replicating in human cells, Modified Vaccinia Ankara vectored vaccine, expressing the EBOV Mayinga glycoprotein, the Sudan virus Gulu GP, the Marburg virus Musoke GP, and the Taï Forest virus nucleoprotein [MVA-BN-Filo]
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases; Vaccines
PIP number: EMEA-002308-PIP01-17-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 19/08/2021, Last updated: 02/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Votubia, everolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000019-PIP02-07-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 22/01/2014, Last updated: 19/02/2014, Compliance check: V, 29/01/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Sirturo, bedaquiline fumarate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000912-PIP01-10-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules
Decision date: 09/09/2020, Last updated: 08/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Votubia, everolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000019-PIP08-12-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 31/10/2017, Last updated: 13/02/2018, Compliance check: V, 01/06/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tobi Podhaler, Tobramycin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000184-PIP01-08-M02, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, Capsule, hard
Decision date: 08/07/2014, Last updated: 05/08/2014, Compliance check: V, 12/09/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Revestive, teduglutide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000482-PIP01-08-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 01/12/2020, Last updated: 23/09/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Blincyto, blinatumomab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000574-PIP02-12-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 18/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Epidyolex, Cannabidiol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001964-PIP01-16-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 29/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Epidyolex, Cannabidiol
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-001964-PIP02-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 18/03/2020, Last updated: 17/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Reblozyl, Luspatercept
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001521-PIP01-13-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Galafold, migalastat hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001194-PIP01-11-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Dispersible tablet
Decision date: 17/04/2019, Last updated: 24/06/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Hetlioz, tasimelteon
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001531-PIP01-13-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral liquid dosage form
Decision date: 17/07/2018, Last updated: 27/11/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rydapt, Midostaurin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000780-PIP01-09-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution, Capsule, soft
Decision date: 19/03/2021, Last updated: 09/11/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Deltyba, Delamanid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001113-PIP01-10-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 14/08/2019, Last updated: 16/09/2021, Compliance check: V, 24/07/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ravicti, Glycerol phenylbutyrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000297-PIP02-12-M02, Route(s) of administration: Oral use, Gastroenteral use, Pharmaceutical form(s): Oral liquid
Decision date: 17/07/2018, Last updated: 27/11/2018, Compliance check: V, 21/09/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Iclusig, ponatinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001186-PIP01-11-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate dosage form, other
Decision date: 12/09/2018, Last updated: 05/02/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Obizur, susoctocog alfa
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000753-PIP02-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 19/12/2017, Last updated: 29/11/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lamzede, velmanase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001056-PIP02-12-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 23/10/2020, Last updated: 21/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kymriah, tisagenlecleucel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001654-PIP01-14-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 10/06/2022, Last updated: 07/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kymriah, tisagenlecleucel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001654-PIP02-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 11/09/2019, Last updated: 26/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001915-PIP01-15-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 14/04/2021, Last updated: 18/01/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vyxeos liposomal (previously known as Vyxeos), daunorubicin, cytarabine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001858-PIP02-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for infusion
Decision date: 14/08/2019, Last updated: 20/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP05-15-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 29/09/2020, Last updated: 08/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP06-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 28/07/2016, Last updated: 20/04/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP03-14-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/12/2020, Last updated: 23/09/2021, Compliance check: X