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3326 results
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Opinion/decision on a Paediatric investigation plan (PIP): Xofluza, Baloxavir marboxil (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002440-PIP01-18-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules for oral suspension
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vitrakvi, Larotrectinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001971-PIP02-16-M04, Route(s) of administration: Gastric use, Oral use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tabelecleucel (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-002025-PIP04-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 21/12/2020, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cyclophosphamide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002644-PIP01-19-M01, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Powder for oral solution
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Soticlestat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002572-PIP02-19-M01, Route(s) of administration: Oral use, Gastric use, Intestinal use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Flucelvax Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1), 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) [QIVc] (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002068-PIP01-16-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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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) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002941-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Deferoxamine (mesylate), histidine, tryptophan, aspartic acid, n-acetyl-histidine (monohydrate), glycine, alpha-ketoglutaric acid, arginine, potassium chloride, magnesium chloride (hexahydrate), calcium chloride (dihydrate), sodium chloride, alanine, 3,4-dimethoxy-N-methylbenzohydroxamic acid (Custodiol-N) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002735-PIP03-20-M01, Pharmaceutical form(s): Solution for organ preservation
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab (updated)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-001501-PIP08-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 17/03/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Verquvo, Vericiguat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001636-PIP01-14-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral liquid dosage form
Decision date: 03/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Aimovig, erenumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001664-PIP02-15-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 03/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, inotuzumab ozogamicin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-001429-PIP01-13-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 03/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cresemba, Isavuconazonium sulfate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001301-PIP02-12-M04, Route(s) of administration: Intravenous use, Oral use, Pharmaceutical form(s): Powder for solution for infusion, Capsule, hard
Decision date: 03/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002862-PIP01-20-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 27/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Breyanzi, Lisocabtagene maraleucel (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001995-PIP01-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 31/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lydisilka, Estetrol, drospirenone (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001332-PIP01-12-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 31/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Palovarotene (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001662-PIP01-14-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 31/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002755-PIP01-19-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 31/12/2021, Last updated: 28/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): glycopyrronium bromide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-002383-PIP01-18-M01, Route(s) of administration: Topical use, Pharmaceutical form(s): Cream
Decision date: 21/12/2021, Last updated: 27/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bavencio, avelumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001849-PIP02-15-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 31/12/2021, Last updated: 27/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Comirnaty, Tozinameran (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002861-PIP02-20-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Concentrate for solution for injection
Decision date: 31/12/2021, Last updated: 27/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tirzepatide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002360-PIP01-18-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 31/12/2021, Last updated: 27/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues (DCR-PHXC) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-002493-PIP01-18-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 31/12/2021, Last updated: 27/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Idefirix, Imlifidase (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002183-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 11/03/2022, Last updated: 23/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Piqray, Alpelisib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002016-PIP03-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 03/12/2021, Last updated: 22/03/2023, Compliance check: X