For help on how to get the results you want, see our search tips.
274 results
Medicine type
Additional monitoring Remove Additional monitoring filter
Accelerated assessment Remove Accelerated assessment filter
Orphan medicine Remove Orphan medicine filter
Generic Remove Generic filter
Medicine
Summaries of opinion Remove Summaries of opinion filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Categories
Human Remove Human filter
-
List item
Summary of opinion: Albrioza
sodium phenylbutyrate, Ursodoxicoltaurine, opinion date: 22/06/2023, Negative, Last updated: 06/07/2023 -
List item
Summary of opinion: Inaqovi
cedazuridine, decitabine, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
List item
Summary of opinion: Bylvay
odevixibat, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
List item
Summary of opinion: Tepkinly
epcoritamab, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
List item
Summary of opinion: Tevimbra
tislelizumab, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
List item
Summary of opinion: Degarelix Accord
degarelix acetate, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
List item
Summary of opinion: Revestive
teduglutide, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Refixia
nonacog beta pegol, opinion date: 22/06/2023, Positive, Last updated: 23/06/2023 -
List item
Summary of opinion: Ronapreve
casirivimab, imdevimab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Jaypirca
pirtobrutinib, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Camzyos
mavacamten, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Adcetris (new)
brentuximab vedotin, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Kaftrio (new)
ivacaftor, tezacaftor, elexacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Kalydeco (new)
ivacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Yorvipath (new)
Palopegteriparatide, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Takhzyro (new)
lanadelumab, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Finlee (new)
dabrafenib, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Vanflyta (new)
quizartinib, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Ryeqo (new)
relugolix, estradiol, norethisterone acetate, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Voxzogo (new)
vosoritide, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: ZILBRYSQ (new)
Zilucoplan, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Enhertu (new)
trastuzumab deruxtecan, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Fetcroja, Cefiderocol (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002133-PIP01-17-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 28/10/2022, Last updated: 28/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Voxzogo, Vosoritide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002033-PIP01-16-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 24/10/2022, Last updated: 28/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Xofluza, Baloxavir marboxil (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002440-PIP01-18-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules for oral suspension
Decision date: 09/09/2022, Last updated: 20/09/2023, Compliance check: X