For help on how to get the results you want, see our search tips.
9 results
Medicine
Maximum residue limits Remove Maximum residue limits filter
Withdrawn applications Remove Withdrawn applications filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Summaries of opinion Remove Summaries of opinion filter
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
RP: decision refers to a refusal on a proposed Paediatric Investigation Plan Remove RP: decision refers to a refusal on a proposed Paediatric Investigation Plan filter
-
List item
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 -
List item
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 -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab
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-001207-PIP02-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 28/01/2021, Last updated: 29/09/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Zejula, Niraparib (tosilate monohydrate)
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-002268-PIP02-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate oral liquid dosage form
Decision date: 10/09/2020, Last updated: 23/03/2020, Compliance check: X -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Epidyolex, Cannabidiol
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-001964-PIP02-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 18/03/2020, Last updated: 17/06/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Kisplyx, Lenvatinib
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-001119-PIP03-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/06/2020, Last updated: 04/03/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ofev, nintedanib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology; Pneumology-allergology
PIP number: EMEA-001006-PIP05-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 17/04/2019, Last updated: 20/06/2019, Compliance check: X