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2090 results
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Opinion/decision on a Paediatric investigation plan (PIP): belantamab mafodotin (updated)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002468-PIP04-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 11/09/2020, Last updated: 19/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): ambrisentan (updated)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002030-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/01/2017, Last updated: 19/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Mepolizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000069-PIP04-13-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection or infusion, Solution for injection
Decision date: 12/09/2018, Last updated: 19/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Triumeq, dolutegravir, abacavir, lamivudine (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001219-PIP01-11-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 03/01/2019, Last updated: 19/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Trelegy Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (updated)
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): Eperzan, Albiglutide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001175-PIP01-11-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 07/10/2016, Last updated: 19/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Benlysta, belimumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000520-PIP02-13-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 06/01/2020, Last updated: 19/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tivicay, dolutegravir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000409-PIP01-08-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Coated tablet, Age-appropriate oral solid dosage form
Decision date: 03/01/2019, Last updated: 19/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Nucala, Mepolizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000069-PIP02-10-M08, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection / infusion, Solution for injection
Decision date: 11/08/2017, Last updated: 19/02/2021, Compliance check: V, 10/11/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002826-PIP01-20-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 05/02/2021, Last updated: 16/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): birch pollen, alder pollen (updated)
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 (updated)
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): Dermatophagoides pteronyssinus, Dermatophagoides farinae (updated)
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 (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: 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 (updated)
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 (updated)
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 (updated)
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): 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): 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): 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): Doptelet, avatrombopag maleate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001136-PIP01-11-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral suspension
Decision date: 22/11/2019, Last updated: 12/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides farinae, Dermatophagoides pteronyssinus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000860-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal solution
Decision date: 27/11/2015, Last updated: 05/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomarata (16%), Lolium perenne (16%), Phleum pratense (16%), Poa pratensis (16%), Anthoxhantum odoratum (16 %) and Secale cereale (20%)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000857-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal solution
Decision date: 27/11/2015, Last updated: 05/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Betula pendula
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000853-PIP01-10-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 27/11/2015, Last updated: 05/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Betula pendula, Corylus avellana, Alnus glutinosa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000852-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal solution
Decision date: 27/11/2015, Last updated: 05/01/2021, Compliance check: X