For help on how to get the results you want, see our search tips.
101 results
Categories
Human Remove Human filter
-
List item
Summary of opinion: Pemazyre (updated)
pemigatinib, opinion date: 28/01/2021, Positive, Last updated: 26/02/2021 -
List item
Summary of opinion: Retsevmo
selpercatinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
List item
Summary of opinion: Lumoxiti
moxetumomab pasudotox, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
List item
Summary of opinion: Kixelle
insulin aspart, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
List item
Summary of opinion: Oyavas
bevacizumab, opinion date: 01/02/2021, Positive, Last updated: 01/02/2021 -
List item
Summary of opinion: Sogroya
somapacitan, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
List item
Summary of opinion: Nexpovio
selinexor, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
List item
Summary of opinion: Alymsys
bevacizumab, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
List item
Summary of opinion: Sirturo
bedaquiline, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
List item
Summary of opinion: Abevmy
bevacizumab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
List item
Summary of opinion: Lextemy
bevacizumab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
List item
Summary of opinion: Jemperli
dostarlimab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
List item
Summary of opinion: Orladeyo
berotralstat, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
List item
Summary of opinion: Epidyolex
cannabidiol, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
List item
Referral: Lartruvo
olaratumab, associated names: Lartruvo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/01/2019, EC decision date: 19/07/2019, Last updated: 22/08/2019 -
List item
Referral: Factor VIII
associated names: Iblias, Elocta, Kovaltry, Nuwiq, Obizur, NovoEight, Voncento, ReFacto AF, Kogenate Bayer, Helixate NexGen, Advate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/09/2017, EC decision date: 10/10/2017, Last updated: 05/12/2017 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Blincyto, blinatumomab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000574-PIP02-12-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 18/04/2020, Last updated: 05/03/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco, ivacaftor (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000335-PIP01-08-M14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules in sachet
Decision date: 17/04/2020, Last updated: 05/03/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Xospata, Gilteritinib (as fumarate) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002064-PIP01-16-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral dosage form
Decision date: 13/05/2020, Last updated: 04/03/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen (updated)
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-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/05/2020, Last updated: 04/03/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Foclivia, Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001830-PIP01-15-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 15/05/2020, Last updated: 04/03/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Symkevi, tezacaftor, ivacaftor (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001640-PIP01-14-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 15/05/2020, Last updated: 04/03/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002826-PIP01-20-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 05/02/2021, Last updated: 16/02/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Crysvita, Burosumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001659-PIP01-15-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/03/2020, Last updated: 04/08/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Alprolix, eftrenonacog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000914-PIP01-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 18/03/2020, Last updated: 03/08/2020, Compliance check: X