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515 results
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Opinion/decision on a Paediatric investigation plan (PIP): Ocaliva, Obeticholic acid
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-001304-PIP03-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Tablet
Decision date: 11/04/2018, Last updated: 25/07/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Teplizumab
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: P/8/2010, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 29/01/2010, Last updated: 16/07/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): thrombin 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: Thrombin alfa, Route(s) of administration: Epilesional use, Pharmaceutical form(s): Powder and solvent for reconstitution
Decision date: 14/08/2008, Last updated: 06/07/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Olodaterol (hydrochloride)
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-001965-PIP01-16, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation solution
Decision date: 11/04/2017, Last updated: 05/07/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ cells transduced with lentiviral vector encoding the human beta-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-001933-PIP01-16, Route(s) of administration: Intraosseous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 31/01/2017, Last updated: 29/06/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Anifrolumab
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-001435-PIP02-16, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
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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: 19/06/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adeno-associated viral vector serotype rh.10 carrying the humanNsulfoglucosamine Nsulfoglucosamine sulfohydrolase cDNA (LYS-SAF302)
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-002122-PIP02-17, Route(s) of administration: Intracerebral use, Pharmaceutical form(s): Solution for infusion
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Plazomicin (sulfate)
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-001639-PIP02-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 19/03/2018, Last updated: 19/06/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Insulin human (NTRA-2112)
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-002116-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral solution
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cadazolid
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-001108-PIP02-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 15/07/2016, Last updated: 08/06/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
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-000876-PIP06-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 28/07/2016, Last updated: 20/04/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Trivalent, seasonal, recombinant influenza hemagglutinin vaccine
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-001133-PIP01-11, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 27/07/2012, Last updated: 20/04/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Solithromycin
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-001581-PIP02-16, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Capsule, hard, Powder for concentrate for solution for infusion, Powder for oral suspension
Decision date: 28/04/2016, Last updated: 20/04/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 1,4-dihydro-1-[(2R)-2-(2-methoxyphenyl)-2-[(tetrahydro-2H-pyran-4-yl)oxy]ethyl]-α,α,5-trimethyl-6-(2-oxazolyl)-2,4-dioxo-thieno[2,3-d]pyrimidine-3(2H)-acetic acid (GS-0976)
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-002109-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 31/01/2018, Last updated: 18/04/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Obiltoxaximab
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-002144-PIP01-17, Route(s) of administration: Solution for infusion, Pharmaceutical form(s): Intravenous drip use
Decision date: 30/01/2018, Last updated: 17/04/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Glutamine (Levoglutamide)
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-001996-PIP02-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral powder
Decision date: 04/01/2018, Last updated: 17/04/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Quilizumab
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-001395-PIP01-12, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 30/10/2013, Last updated: 13/03/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Monoclonal IgG1 anti-influenza A antibody
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-001831-PIP01-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 04/11/2016, Last updated: 06/03/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): budesonide
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-002063-PIP01-16, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Pressurised inhalation, suspension
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cemiplimab
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-002007-PIP02-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Trazodone (hydrochloride)
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-002142-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant humanised IgG4 monoclonal antibody against MSRV-Envelope protein (GNbAC1)
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-002127-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for 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): 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: 05/03/2018, Compliance check: X -
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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