For help on how to get the results you want, see our search tips.
108 results
Categories
Human Remove Human filter
-
List item
Summary of opinion: Ervebo
Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live), opinion date: 17/10/2019, Positive, Last updated: 18/10/2019 -
List item
Summary of opinion: Nepexto
etanercept, opinion date: 26/03/2020, Positive, Last updated: 27/03/2020 -
List item
Summary of opinion: Jorveza
budesonide, opinion date: 26/03/2020, Positive, Last updated: 27/03/2020 -
List item
Summary of opinion: Adcetris
brentuximab vedotin, opinion date: 26/03/2020, Positive, Last updated: 27/03/2020 -
List item
Summary of opinion: Darzalex
daratumumab, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
List item
Summary of opinion: Kalydeco
ivacaftor, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
List item
Summary of opinion: Cablivi
caplacizumab, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
List item
Summary of opinion: Ofev
nintedanib, opinion date: 27/02/2020, Positive, Last updated: 28/02/2020 -
List item
Summary of opinion: Sovaldi
sofosbuvir, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
List item
Summary of opinion: Harvoni
ledispavir / sofosbuvir, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
List item
Summary of opinion: Ofev
nintedanib, opinion date: 28/05/2020, Positive, Last updated: 29/05/2020 -
List item
Summary of opinion: Hepcludex
bulevirtide, opinion date: 28/05/2020, Positive, Last updated: 29/05/2020 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Namuscla, Mexiletine (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002012-PIP01-16-M02, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 04/12/2019, Last updated: 02/04/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001915-PIP01-15-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 04/12/2019, Last updated: 02/04/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001397-PIP04-17-M01, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Film-coated tablet, Oral suspension
Decision date: 06/12/2019, Last updated: 01/04/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Revestive, teduglutide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000482-PIP01-08-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 06/12/2019, Last updated: 31/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Prevymis, Letermovir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001631-PIP01-14-M04, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Granules, Concentrate for solution for infusion
Decision date: 04/11/2019, Last updated: 30/03/2020, Compliance check: X -
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): Kymriah, tisagenlecleucel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001654-PIP02-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 11/09/2019, Last updated: 26/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Cometriq, cabozantinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001143-PIP01-11-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Tablet, Capsule, hard
Decision date: 11/09/2019, Last updated: 26/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Translarna, Ataluren
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000115-PIP01-07-M10, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 11/09/2019, Last updated: 26/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Vyxeos liposomal (previously known as Vyxeos), daunorubicin, cytarabine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001858-PIP02-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for infusion
Decision date: 14/08/2019, Last updated: 20/11/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Deltyba, Delamanid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001113-PIP01-10-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 14/08/2019, Last updated: 20/11/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Bosulif, Bosutinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000727-PIP01-09-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Film-coated tablet
Decision date: 14/08/2019, Last updated: 20/11/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Prepandrix, Purified antigen fractions of inactivated split virion Influenza A/Vietnam/1194/2004 (H5N1) like strain used (NIBRG-14), Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000160-PIP01-07-M05, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 14/08/2019, Last updated: 20/11/2019, Compliance check: X