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548 results
Medicine
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PIP decision type
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): Cenicriviroc (updated)
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-001999-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form, Film-coated tablet
Decision date: 07/12/2018, Last updated: 22/04/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus, Dermatophagoides farinae (updated)
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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Alpha tocotrienol quinone (updated)
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: 31/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Factor VIII Fc - von Willebrand factor - XTEN fusion protein (rFVIIIFc-VWF-XTEN)
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-002501-PIP01-18-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 16/06/2020, Last updated: 17/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): eptinezumab
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-002243-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 16/06/2020, Last updated: 17/03/2021, 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-M01, Route(s) of administration: Intraosseous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 12/06/2020, Last updated: 17/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Trelegy Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002153-PIP01-17-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, pre-dispensed
Decision date: 14/02/2020, Last updated: 19/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): birch pollen, alder pollen
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001012-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Coated tablet
Decision date: 22/03/2019, Last updated: 12/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus, Dermatophagoides farinae
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001014-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Coated tablet
Decision date: 22/03/2019, Last updated: 12/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus, Dermatophagoides farinae
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001011-PIP01-10-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/03/2019, Last updated: 12/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001016-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Coated tablet
Decision date: 22/03/2019, Last updated: 12/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): birch pollen, alder pollen
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001013-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal drops
Decision date: 22/03/2019, Last updated: 12/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001017-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal drops
Decision date: 22/03/2019, Last updated: 12/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Brazikumab
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-001929-PIP01-16, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection, Solution for infusion
Decision date: 19/12/2017, Last updated: 21/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium
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-002214-PIP01-17, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 12/09/2018, Last updated: 21/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chimeric anti-disialoganglioside (GD2) monoclonal antibody (ch14.18/CHO) (APN311)
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-001314-PIP01-12, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion, Powder and solvent for solution for injection, Powder for solution for infusion
Decision date: 07/04/2014, Last updated: 12/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: Purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1), Route(s) of administration: Intramuscular injection, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 24/04/2009, Last updated: 26/11/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Molidustat (sodium)
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-001546-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral liquid
Decision date: 27/10/2014, Last updated: 25/11/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): fremanezumab
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-001877-PIP03-17, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 19/12/2017, Last updated: 25/11/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): meropenem trihydrate
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-001731-PIP01-14, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 22/10/2015, Last updated: 12/10/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl) cyclobutyl)-3-phenylisoxazole-5-
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-002398-PIP01-18, Route(s) of administration: Capsule, hard, Age-appropriate oral dosage form, Pharmaceutical form(s): Oral use
Decision date: 17/05/2019, Last updated: 12/10/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647)
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-002218-PIP01-17, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 12/09/2018, Last updated: 07/10/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): captopril
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-001544-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form
Decision date: 08/08/2014, Last updated: 11/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Live, attenuated, chimeric dengue virus, serotype 1, live, attenuated dengue virus, serotype 2, live, attenuated, chimeric dengue virus, serotype 3, live attenuated, chimeric dengue virus, serotype 4
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-001888-PIP01-15, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 03/07/2017, Last updated: 29/04/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Norovirus GI.1 virus-like particle antigen, norovirus GII.4 virus-like particle 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-001609-PIP01-14, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 05/06/2015, Last updated: 29/04/2020, Compliance check: X