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Opinion/decision on a Paediatric investigation plan (PIP): Zeposia, Ozanimod (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001710-PIP03-17-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 08/06/2021, Last updated: 02/12/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vipidia, alogliptin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000496-PIP01-08-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/07/2020, Last updated: 02/12/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Voclosporin
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-002264-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 17/04/2019, Last updated: 02/12/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): SER-109 (Eubacterial Spores, Purified Suspension, Encapsulated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001970-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Oral suspension
Decision date: 07/12/2018, Last updated: 23/11/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Linear single strand of deoxyribonucleic acid (encoding human retinitis pigmentosa GTPase regulator [RPGR]) packaged in a recombinant adeno-associated virus protein capsid of serotype 5 (AAV5-hRKp.RPGR)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Ophthalmology
PIP number: EMEA-002827-PIP01-20, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Solution for injection
Decision date: 17/03/2021, Last updated: 17/11/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Entyvio, vedolizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology; Immunology-Rheumatology-Transplantation
PIP number: EMEA-000645-PIP03-18, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion, Solution for injection
Decision date: 14/08/2019, Last updated: 09/11/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sparsentan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001984-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral liquid dosage form
Decision date: 27/01/2021, Last updated: 07/11/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sparsentan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Uro-nephrology
PIP number: EMEA-001984-PIP03-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form, Tablet
Decision date: 27/01/2021, Last updated: 07/11/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Nonacog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001139-PIP01-11-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 29/01/2016, Last updated: 10/10/2022, Compliance check: V, 29/06/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant porcine factor VIII, B-domain deleted
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000753-PIP01-11, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection, Powder and solvent for solution for injection
Decision date: 24/02/2012, Last updated: 10/10/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): ketamine (hydrochloride), sufentanil citrate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pain
PIP number: EMEA-001739-PIP02-16, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray, solution
Decision date: 06/12/2019, Last updated: 27/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Giroctocogene fitelparvovec
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-002724-PIP01-19-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 05/08/2021, Last updated: 14/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): cenobamate
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-002563-PIP02-19-M01, Route(s) of administration: Oral use, Parenteral use, Gastric use, Pharmaceutical form(s): Tablet, Film-coated tablet, Age-appropriate oral liquid dosage form, Age-appropriate dosage form for parenteral use
Decision date: 13/08/2021, Last updated: 14/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lebrikizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-002536-PIP01-18-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 11/08/2021, Last updated: 14/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Phenobarbital
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-002532-PIP01-18-M01, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Oral suspension
Decision date: 13/08/2021, Last updated: 14/09/2022, 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-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): In vitro expanded autologous human articular chondrocytes
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002217-PIP01-17-M02, Route(s) of administration: Intraarticular use, Pharmaceutical form(s): Implant
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): 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-Paediatric 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