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518 results
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Opinion/decision on a Paediatric investigation plan (PIP): Iron hydroxyethyl amylopectin heptonate
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-002094-PIP01-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 01/12/2017, Last updated: 05/03/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Allopregnanolone
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Psychiatry
PIP number: EMEA-002051-PIP02-16, Route(s) of administration: Solution for infusion, Pharmaceutical form(s): Intravenous use
Decision date: 01/12/2017, Last updated: 05/03/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): eptacog alfa (activated)
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-001382-PIP01-12, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 30/10/2013, Last updated: 26/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lixivaptan
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-001078-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 26/10/2011, Last updated: 23/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Mesalazine, prednisolone metasulphobenzoate
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-001406-PIP01-12, Route(s) of administration: Rectal use, Pharmaceutical form(s): Rectal suspension
Decision date: 22/01/2014, Last updated: 23/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lactobacillus reuteri (IBP-9414)
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-001895-PIP01-15, Route(s) of administration: Gastroenteral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 31/10/2017, Last updated: 13/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Enasidenib
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-001798-PIP02-16, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 04/10/2017, Last updated: 13/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab
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-001776-PIP02-17, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection, Age-appropriate pharmaceutical form
Decision date: 23/11/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Phenyl- and piperidin-containing derivative of amiloride (BI 443651)
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-002082-PIP01-16, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation solution
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Entospletinib
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-002058-PIP01-16, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Atacicept
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-002004-PIP01-16, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 05/09/2017, Last updated: 24/10/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Selonsertib
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-001868-PIP03-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/09/2017, Last updated: 24/10/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fc- and CDR-modified humanised monoclonal antibody against C5 (ravulizumab)
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-002077-PIP01-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 14/07/2017, Last updated: 28/09/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fluocinolone acetonide
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-000801-PIP03-16, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Intravitreal implant in applicator
Decision date: 08/06/2017, Last updated: 24/07/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Humanised monoclonal antibody IgG2 recognising the interleukin-31 receptor A (CIM331)
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-001624-PIP01-14, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 13/05/2015, Last updated: 14/07/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 3,6-diamino-2,5-bis{N-[(1R)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine (MB-102)
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-001983-PIP01-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 05/05/2017, Last updated: 03/07/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Macimorelin
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-001988-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral solution
Decision date: 11/04/2017, Last updated: 29/05/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): rVSVĪG-ZEBOV-GP
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-001786-PIP01-15, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 11/04/2017, Last updated: 29/05/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): T-lymphocytes enriched leukocyte preparation depleted ex vivo of host host-alloreactive T cells using photodynamic treatment (ATIR101)
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-001980-PIP01-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Cell suspension for infusion
Decision date: 16/03/2017, Last updated: 21/04/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Orencia, Abatacept
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-000118-PIP03-15, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion, Solution for injection
Decision date: 16/01/2017, Last updated: 17/03/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pegvaliase
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-001951-PIP01-16, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 31/01/2017, Last updated: 17/03/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Varicella-zoster virus (inactivated)
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-001073-PIP02-14, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for suspension for injection
Decision date: 31/01/2017, Last updated: 17/03/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Galcanezumab
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-001860-PIP04-16, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 21/12/2016, Last updated: 30/01/2017, 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: 30/01/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pimavanserin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Psychiatry
PIP number: EMEA-001688-PIP03-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 02/12/2016, Last updated: 30/01/2017, Compliance check: X