For help on how to get the results you want, see our search tips.
2556 results
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: Tibsovo
ivosidenib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
List item
Summary of opinion: Tidhesco
ivosidenib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
List item
Summary of opinion: Opzelura
ruxolitinib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
List item
Summary of opinion: Elfabrio
pegunigalsidase alfa, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
List item
Summary of opinion: Vafseo
vadadustat, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
List item
Summary of opinion: Libtayo
cemiplimab, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
List item
Summary of opinion: Bekemv
eculizumab, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
List item
Summary of opinion: Hyftor
sirolimus, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
List item
Summary of opinion: Esbriet
pirfenidone, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
List item
Summary of opinion: Akeega
niraparib, abiraterone acetate, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
List item
Summary of opinion: Imcivree
setmelanotide, opinion date: 21/07/2022, Positive, Last updated: 22/07/2022 -
List item
Summary of opinion: Vegzelma
bevacizumab, opinion date: 23/06/2022, Positive, Last updated: 21/06/2022 -
List item
Summary of opinion: Newflend ND H9 (new)
turkey herpes virus, strain rHVT/ND expressing Newcastle disease virus, live, opinion date: 23/03/2023, Positive, Last updated: 24/03/2023 -
List item
Summary of opinion: Comirnaty
tozinameran, riltozinameran and tozinameran, famtozinameran and tozinameran, COVID-19 mRNA Vaccine (nucleoside modified), opinion date: 19/10/2022, Positive, Last updated: 19/10/2022 -
List item
Summary of opinion: Rinvoq
upadacitinib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
List item
Summary of opinion: Bimervax (new)
(COVID-19 Vaccine (recombinant, adjuvanted)), opinion date: 30/03/2023, Positive, Last updated: 30/03/2023 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Verquvo, Vericiguat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001636-PIP01-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral liquid dosage form
Decision date: 28/10/2022, Last updated: 30/03/2023, 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-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules for oral suspension
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Vitrakvi, Larotrectinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001971-PIP02-16-M04, Route(s) of administration: Gastric use, Oral use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tabelecleucel (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-002025-PIP04-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 21/12/2020, Last updated: 29/03/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Cyclophosphamide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002644-PIP01-19-M01, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Powder for oral solution
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Soticlestat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002572-PIP02-19-M01, Route(s) of administration: Oral use, Gastric use, Intestinal use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Flucelvax Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc] (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002068-PIP01-16-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Nuvaxovid, Severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine/ matrix-M1 adjuvant (NVX-CoV2373) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002941-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Deferoxamine (mesylate), histidine, tryptophan, aspartic acid, n-acetyl-histidine (monohydrate), glycine, alpha-ketoglutaric acid, arginine, potassium chloride, magnesium chloride (hexahydrate), calcium chloride (dihydrate), sodium chloride, alanine, 3,4-dimethoxy-N-methylbenzohydroxamic acid (Custodiol-N) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002735-PIP03-20-M01, Pharmaceutical form(s): Solution for organ preservation
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X