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800 results
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Opinion/decision on a Paediatric investigation plan (PIP): PEGylated-fibroblast growth factor 21 (BMS-986036) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002448-PIP01-18-M02, Route(s) of administration: Subcutaneous use,
Decision date: 18/08/2021, Last updated: 14/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kymriah, tisagenlecleucel (updated)
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): 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): 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: 02/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 4 - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 5 - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 6A- diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 6B - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 7F - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 9V - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 14 - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 18C - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 19A - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 19F - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 22F - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 23F - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 33F – diphtheria CRM197 conjugate (15-valent pneumococcal polysaccharide conjugate vaccine [V114])
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002215-PIP01-17-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 09/08/2021, Last updated: 01/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Temelimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002127-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 12/08/2021, Last updated: 01/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fasinumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: EMEA-002059-PIP02-19-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 12/08/2021, Last updated: 01/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tralokinumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001900-PIP02-17-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 11/08/2022, Last updated: 01/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lactobacillus reuteri (IBP-9414)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology; Neonatology-Paediactric Intensive care; Other
PIP number: EMEA-001895-PIP01-15-M01, Route(s) of administration: Gastroenteral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 11/08/2021, Last updated: 01/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): ligelizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001811-PIP02-15-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection, Age-appropriate dosage form for parenteral use
Decision date: 11/08/2021, Last updated: 01/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-respiratory syncytial virus human IgG1κ monoclonal antibody (MEDI8897)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases; Vaccines
PIP number: EMEA-001784-PIP01-15-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 11/08/2021, Last updated: 01/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kerendia, Finerenone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001623-PIP01-14-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral (liquid or solid) dosage form
Decision date: 11/08/2021, Last updated: 01/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Selumetinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001585-PIP01-13-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral dosage form, Capsule, hard
Decision date: 12/08/2021, Last updated: 01/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001501-PIP01-13-M07, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 11/08/2021, Last updated: 01/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sirolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-001416-PIP01-12-M03, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 11/08/2021, Last updated: 01/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001397-PIP03-14-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard
Decision date: 11/08/2021, Last updated: 01/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adynovi, rurioctocog alfa pegol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001296-PIP01-12-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 11/08/2021, Last updated: 01/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, baricitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001220-PIP03-16-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Tablet
Decision date: 11/08/2021, Last updated: 31/08/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Feraccru, ferric maltol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001195-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Oral suspension
Decision date: 11/08/2021, Last updated: 31/08/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): procaine (hydrochloride), xylitol, potassium chloride, magnesium sulfate heptahydrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001171-PIP01-11-M02, Route(s) of administration: Intracoronary use, Pharmaceutical form(s): Solution for injection
Decision date: 11/08/2021, Last updated: 31/08/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Heplisav B, Hepatitis B (rDNA) surface antigen adjuvanted
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001127-PIP02-11-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 11/08/2021, Last updated: 31/08/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Uptravi, Selexipag
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000997-PIP01-10-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Tablet
Decision date: 13/08/2021, Last updated: 31/08/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Exparel liposomal, bupivacaine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: EMEA-000877-PIP03-17-M03, Route(s) of administration: Perineural use, Infiltration use, Pharmaceutical form(s): Suspension for injection, Prolonged-release dispersion for injection
Decision date: 09/08/2021, Last updated: 31/08/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Brintellix, Vortioxetine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-000455-PIP02-10-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral liquid dosage form
Decision date: 13/08/2021, Last updated: 31/08/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vimpat, lacosamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000402-PIP03-17-M05, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Solution for infusion, Syrup
Decision date: 20/08/2021, Last updated: 31/08/2022, Compliance check: X