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158 results
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Paediatric investigation plans Remove Paediatric investigation plans filter
PIP decision type
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) Remove RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) filter
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Opinion/decision on a Paediatric investigation plan (PIP): Rekambys, rilpivirine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000317-PIP02-18-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Prolonged release suspension for injection
Decision date: 09/09/2022, Last updated: 14/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lenvima, Lenvatinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001119-PIP02-12-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 10/08/2022, Last updated: 13/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001207-PIP02-19-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 10/08/2022, Last updated: 13/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Doptelet, Avatrombopag
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001136-PIP02-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral suspension
Decision date: 09/12/2020, Last updated: 01/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ronapreve, Imdevimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002965-PIP01-21-M02, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 10/08/2022, Last updated: 31/08/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ronapreve, Casirivimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002964-PIP01-21-M02, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 10/08/2022, Last updated: 31/08/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vydura, Rimegepant
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002812-PIP02-20-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral lyophilisate
Decision date: 10/08/2022, Last updated: 31/08/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Hepcludex, Bulevirtide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002399-PIP01-18-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 10/08/2022, Last updated: 31/08/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dovprela (previously Pretomanid FGK), Pretomanid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002115-PIP01-17-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Tablet
Decision date: 11/08/2022, Last updated: 30/08/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vitrakvi, Larotrectinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001971-PIP03-18-M02, Route(s) of administration: Gastric use, Oral use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 11/08/2022, Last updated: 30/08/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Imcivree, Setmelanotide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Nutrition
PIP number: EMEA-002209-PIP01-17-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 10/08/2022, Last updated: 28/08/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vocabria, Cabotegravir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001418-PIP02-15-M03, Route(s) of administration: Oral use, Intramuscular use, Pharmaceutical form(s): Film-coated tablet, Prolonged-release suspension for injection
Decision date: 17/03/2022, Last updated: 30/06/2023, Compliance check: V, 20/05/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Wakix, pitolisant
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001176-PIP01-11-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/01/2021, Last updated: 30/06/2023, Compliance check: V, 20/05/2022 -
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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: 30/06/2023, Compliance check: V, 24/06/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Zabdeno, Monovalent, live, recombinant, replication-incompetent adenoviral serotype 26 vectored vaccine expressing the full length glycoprotein of the Ebola virus Mayinga variant [Ad26.ZEBOV]
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases; Vaccines
PIP number: EMEA-002307-PIP01-17-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 12/08/2021, Last updated: 30/06/2023, Compliance check: V, 24/06/2022 -
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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: 30/06/2023, Compliance check: V, 24/06/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Foclivia, Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001830-PIP01-15-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 15/05/2020, Last updated: 30/06/2023, Compliance check: V, 16/12/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Nuvaxovid, Severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine/ matrix-M1 adjuvant (NVX-CoV2373)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002941-PIP01-20-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 08/07/2022, Last updated: 29/06/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Spikevax (previously COVID-19 Vaccine Moderna), Elasomeran / imelasomeran Elasomeran
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases; Vaccines
PIP number: EMEA-002893-PIP01-20-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Dispersion for injection
Decision date: 30/06/2022, Last updated: 29/06/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002826-PIP01-20-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 24/06/2022, Last updated: 29/06/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Brukinsa, zanubrutinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002354-PIP02-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 10/06/2022, Last updated: 29/06/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-002077-PIP01-16-M05, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 10/06/2022, Last updated: 29/06/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Comirnaty, Tozinameran
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002861-PIP02-20-M05, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Concentrate for dispersion for injection, Dispersion for injection
Decision date: 31/12/2021, Last updated: 26/06/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Beyfortus, Nirsevimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001784-PIP01-15-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 08/07/2022, Last updated: 23/06/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, Upadacitinib (ABT-494)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001741-PIP03-16-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet, Age-appropriate oral solid dosage form, Age-appropriate oral liquid dosage form
Decision date: 13/07/2022, Last updated: 23/06/2023, Compliance check: X