For help on how to get the results you want, see our search tips.
107 results
Medicine
Summaries of opinion Remove Summaries of opinion filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Referrals Remove Referrals filter
Medicine type
Orphan medicine Remove Orphan medicine 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: Revestive
teduglutide, 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: 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: 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: 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
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): Besponsa, Inotuzumab ozogamicin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-001429-PIP01-13-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 09/09/2022, Last updated: 19/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Crysvita, Burosumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001659-PIP01-15-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 30/09/2022, Last updated: 18/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Cometriq, cabozantinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001143-PIP01-11-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Tablet, Capsule, hard
Decision date: 11/08/2022, Last updated: 13/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001207-PIP02-19-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 10/08/2022, Last updated: 13/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Hepcludex, Bulevirtide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002399-PIP01-18-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 10/08/2022, Last updated: 31/08/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Dovprela (previously Pretomanid FGK), Pretomanid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002115-PIP01-17-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Tablet
Decision date: 11/08/2022, Last updated: 30/08/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Imcivree, Setmelanotide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Nutrition
PIP number: EMEA-002209-PIP01-17-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 10/08/2022, Last updated: 28/08/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Wakix, pitolisant
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001176-PIP01-11-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/01/2021, Last updated: 30/06/2023, Compliance check: V, 20/05/2022 -
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: 30/06/2023, Compliance check: V, 24/06/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Takhzyro, Lanadelumab (DX-2930)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001864-PIP01-15-M07, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 10/06/2022, Last updated: 30/06/2023, Compliance check: V, 09/09/2022