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41 results
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Opinion/decision on a Paediatric investigation plan (PIP): Coagadex, Human coagulation factor X
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000971-PIP01-10-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection or infusion
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: V, 26/01/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Isentress, Raltegravir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000279-PIP01-08-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Chewable tablet, Granules for oral suspension
Decision date: 15/06/2016, Last updated: 02/03/2018, Compliance check: V, 19/06/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP02-11-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 21/12/2012, Last updated: 02/03/2018, Compliance check: V, 02/06/2015 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tagrisso, Osimertinib (as mesilate)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002125-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 09/08/2017, Last updated: 28/09/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vargatef, nintedanib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001006-PIP03-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
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): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP01-10-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 24/10/2014, Last updated: 02/03/2017, 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-PIP07-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 01/09/2016, Last updated: 27/10/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ofev, nintedanib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001006-PIP02-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 27/10/2015, Last updated: 11/07/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vidaza, azacitidine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001272-PIP02-13-M01, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Powder for suspension for injection, Powder for solution for infusion
Decision date: 02/10/2015, Last updated: 23/11/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Empliciti, Elotuzumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002377-PIP01-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 13/08/2018, Last updated: 18/01/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Oxervate, Cenegermin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-001729-PIP02-18, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 17/04/2019, Last updated: 25/06/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kyprolis, carfilzomib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001806-PIP03-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 15/05/2019, Last updated: 29/10/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kyprolis, carfilzomib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-001806-PIP04-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 27/01/2021, Last updated: 29/09/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pelgraz, pegfilgrastim
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-002671-PIP02-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection in pre-filled syringe
Decision date: 10/05/2021, Last updated: 11/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Darzalex, Daratumumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002152-PIP03-19, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 18/03/2020, Last updated: 28/07/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Takhzyro, lanadelumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-001864-PIP02-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/04/2020, Last updated: 03/03/2021, Compliance check: X