For help on how to get the results you want, see our search tips.
28 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Summaries of opinion Remove Summaries of opinion filter
Paediatric investigation plans Remove Paediatric investigation plans filter
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Daklinza, Daclatasvir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-001191-PIP01-11-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Chewable tablet, Film-coated tablet
Decision date: 08/11/2019, Last updated: 30/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Lartruvo, Olaratumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001760-PIP01-15-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/03/2019, Last updated: 24/06/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Olysio, simeprevir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-000625-PIP01-09-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form, other
Decision date: 12/09/2018, Last updated: 05/02/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Zydelig, Idelalisib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001350-PIP02-13-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate dispersible tablet
Decision date: 09/11/2018, Last updated: 28/01/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Pixuvri, pixantrone dimaleate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000713-PIP02-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 20/07/2018, Last updated: 28/11/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Revlimid, lenalidomide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000371-PIP04-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tagrisso, Osimertinib (as mesylate)
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Xofigo, radium Ra223 dichloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001986-PIP01-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 03/07/2017, Last updated: 24/07/2017, Compliance check: X -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Nucala, Mepolizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000069-PIP05-16, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection, Powder for solution for injection
Decision date: 05/05/2017, Last updated: 03/07/2017, Compliance check: X -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP02-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 07/08/2015, Last updated: 17/12/2015, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Revlimid, lenalidomide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000371-PIP02-09, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 04/03/2011, Last updated: 08/04/2011, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Revlimid, lenalidomide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000371-PIP01-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 06/11/2008, Last updated: 07/01/2009, Compliance check: X -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Kevzara, sarilumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001045-PIP04-18, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 07/12/2018, Last updated: 20/02/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Braftovi, Encorafenib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001588-PIP03-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 29/01/2019, Last updated: 11/04/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Mektovi, binimetinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001454-PIP05-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 29/01/2019, Last updated: 11/04/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Kevzara, sarilumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001045-PIP02-18, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/10/2018, Last updated: 11/01/2019, 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): 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 -
List item
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: Powder for solution for infusion, Pharmaceutical form(s): Intravenous use
Decision date: 15/05/2019, Last updated: 29/10/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Zejula, Niraparib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002268-PIP03-18, Route(s) of administration: Capsule, hard, Film-coated tablet, Pharmaceutical form(s): Oral use
Decision date: 15/05/2019, Last updated: 29/10/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002342-PIP03-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 12/06/2019, Last updated: 07/11/2019, Compliance check: X -
List item
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