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Opinion/decision on a Paediatric investigation plan (PIP): Quviviq, Daridorexant
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-002121-PIP03-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Film-coated tablet
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Leriglitazone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002106-PIP01-16-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Viread, tenofovir disoproxil fumarate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000533-PIP01-08-M11, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Yescarta, Axicabtagene ciloleucel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002010-PIP01-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Edurant, Rilpivirine (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000317-PIP01-08-M13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate solid oral formulation
Decision date: 12/08/2020, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Emgality, Galcanezumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001860-PIP03-16-M07, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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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-PIP04-17-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral liquid dosage form
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zinplava, Bezlotoxumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001645-PIP01-14-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Truberzi, Eluxadoline
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001579-PIP01-13-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Parsabiv, Etelcalcetide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001554-PIP01-13-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): CpG 1018/Alum-adjuvanted recombinant SARS-CoV-2 Trimeric Spike (S) protein subunit vaccine (SCB- 2019)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-002987-PIP01-21, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Nulibry, Fosdenopterin (ORGN001)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001491-PIP01-13-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: V, 15/10/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, Inotuzumab ozogamicin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-001429-PIP01-13-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Spravato, Esketamine (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001428-PIP03-15-M02, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray, solution
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fasenra, Benralizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001214-PIP01-11-M11, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/04/2022, Last updated: 19/04/2023, 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-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001194-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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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-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate formulation
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Mayzent, Siponimod (hemifumarate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000716-PIP01-09-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 13/04/2022, Last updated: 17/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Arikayce liposomal, Amikacin sulfate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000525-PIP01-08-M08, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Nebuliser dispersion
Decision date: 13/04/2022, Last updated: 17/04/2023, 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-M01, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 03/02/2022, Last updated: 17/04/2023, 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-M01, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 03/02/2022, Last updated: 17/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cilgavimab (AZD1061)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002925-PIP01-20-M01, Route(s) of administration: Intramuscular use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 11/02/2022, Last updated: 17/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): VidPrevtyn Beta, SARS-CoV2 prefusion Spike delta TM (CoV-2 preS dTM) adjuvanted with AS03
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002915-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution and emulsion for emulsion for injection
Decision date: 14/02/2022, Last updated: 17/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tixagevimab (AZD8895)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002900-PIP01-20-M01, Route(s) of administration: Intramuscular use, Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 11/02/2022, Last updated: 17/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded (MC0518)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002706-PIP01-19-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 01/02/2022, Last updated: 17/04/2023, Compliance check: X