For help on how to get the results you want, see our search tips.
54 results
Medicine
Paediatric investigation plans Remove Paediatric investigation plans filter
Summaries of opinion Remove Summaries of opinion filter
Medicine type
Generic Remove Generic filter
Exceptional circumstances Remove Exceptional circumstances filter
Accelerated assessment Remove Accelerated assessment filter
Additional monitoring Remove Additional monitoring 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
W: decision granting a waiver in all age groups for all conditions or indications Remove W: decision granting a waiver in all age groups for all conditions or indications filter
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Nexpovio, Selinexor (new)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002387-PIP02-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 08/09/2021, Last updated: 10/01/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Alecensa, Alectinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002431-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 07/12/2018, Last updated: 13/02/2019, Compliance check: X -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Beovu, Brolucizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-002691-PIP02-20, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 23/10/2020, Last updated: 22/07/2021, Compliance check: X