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642 results
Medicine
Paediatric investigation plans Remove Paediatric investigation plans filter
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PIP decision type
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) Remove RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) filter
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Remove P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter
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Opinion/decision on a Paediatric investigation plan (PIP): Tanezumab
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-001635-PIP03-17, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/03/2018, Last updated: 12/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zorecimeran
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-002986-PIP01-21, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Concentrate and solvent for dispersion for injection
Decision date: 17/05/2021, Last updated: 11/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Mecasermin rinfabate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediactric Intensive care
PIP number: EMEA-000534-PIP03-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 28/02/2020, Last updated: 05/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Venglustat
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism; Uro-nephrology
PIP number: EMEA-001716-PIP05-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 22/12/2020, Last updated: 24/03/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Clazakizumab
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-001371-PIP01-12, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/02/2014, Last updated: 21/03/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): (R)-1-(1-acryloylpiperidin-3-yl)-4-amino-3-(4-phenoxyphenyl)-1H-imidazo[4,5-c]pyridin-2(3H)-one (SAR442168)
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-002566-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 14/08/2020, Last updated: 09/03/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human βA-T87Q-globin gene
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-001665-PIP02-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 16/07/2019, Last updated: 09/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dipalmitoylphosphatidylcholine, 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol sodium salt, synthetic surfactant protein C analogue, synthetic surfactant protein B analogue (CHF 5633)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediactric Intensive care
PIP number: EMEA-001780-PIP01-15, Route(s) of administration: Endotracheopulmonary use, Pharmaceutical form(s): Endotracheopulmonary instillation, suspension
Decision date: 21/12/2016, Last updated: 10/12/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Human immunoglobulin G2 isotype antibody to IL-33R
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002515-PIP01-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 10/02/2020, Last updated: 01/12/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Obizur, susoctocog alfa
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-000753-PIP02-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 19/12/2017, Last updated: 29/11/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 2-[[2-ethyl-6-[4-[2-(3-hydroxyazetidin-1-yl)-2-oxoethyl]piperazin-1-yl]-8-methylimidazo[1,2-a]pyridin-3-yl](methyl)amino]-4-(4-fluorophenyl)-1,3-thiazole-5-carbonitrile
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002333-PIP02-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate formulation
Decision date: 18/04/2020, Last updated: 29/11/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Carisbamate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: Carisbamate, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Oral suspension, Intravenous formulation
Decision date: 09/06/2009, Last updated: 22/11/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): [(3S)-6-({2',6'-Dimethyl-4'-[3-(methylsulfonyl) propoxy] biphenyl-3-yl}methoxy)-2,3-dihydro-1-benzofuran-3-yl]acetic acid hydrate (TAK-875)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000734-PIP01-09, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 26/11/2010, Last updated: 19/11/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Emicizumab
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-001839-PIP01-15, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/07/2016, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Descovy, emtricitabine, tenofovir alafenamide
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-001577-PIP03-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 07/05/2018, Last updated: 21/09/2021, Compliance check: V, 20/09/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Mometasone (furoate monohydrate), Olopatadine (hydrochloride) (GSP 301 NS)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-002514-PIP01-18, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray, suspension
Decision date: 15/05/2019, Last updated: 21/09/2021, Compliance check: V, 27/03/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lonafarnib
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-002516-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/07/2019, Last updated: 20/09/2021, Compliance check: V, 27/03/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): glucarpidase
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-001391-PIP01-12, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 30/07/2013, Last updated: 16/09/2021, Compliance check: V, 24/07/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lonapegsomatropin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002692-PIP01-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 15/07/2020, Last updated: 16/09/2021, Compliance check: X, 04/09/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir
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-001904-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Film-coated tablet
Decision date: 16/11/2018, Last updated: 01/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-neonatal Fc receptor human monoclonal antibody
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-002559-PIP02-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion
Decision date: 18/03/2020, Last updated: 01/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human acid ceramidase (RVT-801)
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-002266-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 12/09/2018, Last updated: 30/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bulevirtide
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-002399-PIP01-18, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 26/08/2019, Last updated: 30/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Alpha tocotrienol quinone
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-001238-PIP01-12, Route(s) of administration: Oral use, Enteral use, Pharmaceutical form(s): Oral solution
Decision date: 30/07/2013, Last updated: 07/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus, Dermatophagoides farinae
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001015-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal drops
Decision date: 09/06/2011, Last updated: 21/04/2021, Compliance check: X