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652 results
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-CD7 mAb conjugated to ricin toxin A chain, Anti-CD3 mAb conjugated to ricin toxin A chain (updated)
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-002087-PIP01-16-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ioforminol (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Diagnostic
PIP number: EMEA-001197-PIP01-11, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 01/10/2012, Last updated: 04/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridin-2-yl)-4- fluoropyrrolidine-2-carboxamide (ACH-0144471) (updated)
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-002310-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid dosage form
Decision date: 17/07/2019, Last updated: 01/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+enriched cells from patients with Fanconi anaemia subtype A transduced ex vivo with a lentiviral vector carrying the FANCA gene (PGK-FANCA-WPRE) (updated)
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-002578-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 18/03/2020, Last updated: 29/08/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Iscalimab
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-002842-PIP01-20, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection, Concentrate for solution for infusion
Decision date: 08/06/2021, Last updated: 22/08/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adalimumab conjugated with (4S)-4-[2-(2-bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)-5-hydroxy-4a,6a-dimethyl-2-oxo-6b-[(phosphonooxy)acetyl]-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8-yl}phenyl)methyl] anilino}-5-oxopentanoic acid; (ABBV-154)
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-002927-PIP01-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection (in pre-filled syringe)
Decision date: 29/10/2010, Last updated: 03/08/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Molnupiravir
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-002940-PIP02-21, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form
Decision date: 31/12/2021, Last updated: 07/07/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): AZD8233 sodium, PCSK9-targeted, antisense oligonucleotide (ASO)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002962-PIP01-21, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 29/10/2021, Last updated: 06/07/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Benzylamine derivative of benzofuran (BCX9930)
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-002974-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Tablet
Decision date: 15/04/2022, Last updated: 06/07/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): ligelizumab
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-001811-PIP04-21, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection, Age-appropriate dosage form for parenteral use
Decision date: 08/09/2021, Last updated: 06/07/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Nifurtimox
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-003134-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/03/2022, Last updated: 30/06/2023, Compliance check: V, 09/09/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): artesunate
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-002710-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 14/08/2020, Last updated: 30/06/2023, Compliance check: V, 09/09/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen
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-002869-PIP03-21, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 13/04/2022, Last updated: 30/06/2023, Compliance check: V, 09/09/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Virus-like particle of SARS-CoV-2 spike protein (recombinant, adjuvant) (CoVLP)
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-003008-PIP01-21, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for emulsion for injection
Decision date: 13/05/2022, Last updated: 29/06/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ribitol
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002887-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral use, Age-appropriate oral dosage form
Decision date: 08/09/2021, Last updated: 27/06/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): liposomal ciclosporin A (L-CsA)
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-002344-PIP02-18-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Powder for nebuliser solution
Decision date: 08/07/2022, Last updated: 27/06/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-(1-(6-Amino-5-chloropyrimidine-4-carboxamido)ethyl)-N-(5-chloro-4-(trifluoromethyl)pyridin-2-yl)thiazole-5-carboxamide (DAY101)
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-002763-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Tablet
Decision date: 22/12/2020, Last updated: 05/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): abelacimab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003017-PIP01-21, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for injection
Decision date: 13/04/2022, Last updated: 25/04/2023, 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): Tabelecleucel
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): Loncastuximab tesirine
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-002665-PIP02-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 01/10/2021, Last updated: 14/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Eylea, aflibercept
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-000236-PIP05-18, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 04/04/2019, Last updated: 13/03/2023, Compliance check: V, 15/10/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): surufatinib
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-002750-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Powder for oral suspension
Decision date: 14/04/2021, Last updated: 17/02/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adeno-associated viral vector serotype 8 containing the human MTM1 gene (resamirigene bilparvovec)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002571-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 14/08/2020, Last updated: 31/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Relamorelin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002323-PIP02-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Age-appropriate oral dosage form, Solution for injection
Decision date: 09/09/2020, Last updated: 12/01/2023, Compliance check: X