For help on how to get the results you want, see our search tips.
172 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Direct healthcare professional communication Remove Direct healthcare professional communication filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Orphan designations Remove Orphan designations filter
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Zabdeno, Monovalent, live, recombinant, replication-incompetent adenoviral serotype 26 vectored vaccine expressing the full length glycoprotein of the Ebola virus Mayinga variant [Ad26.ZEBOV]
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases; Vaccines
PIP number: EMEA-002307-PIP01-17-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 12/08/2021, Last updated: 30/06/2023, Compliance check: V, 24/06/2022 -
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): Ofev, nintedanib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology; Pneumology-allergology
PIP number: EMEA-001006-PIP05-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 29/10/2021, Last updated: 30/06/2023, Compliance check: V, 22/07/2022 -
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP05-15-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 11/03/2022, Last updated: 30/06/2023, Compliance check: V, 14/10/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Foclivia, Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
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: 30/06/2023, Compliance check: V, 16/12/2022 -
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)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002941-PIP01-20-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 08/07/2022, Last updated: 29/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Spikevax (previously COVID-19 Vaccine Moderna), Elasomeran / imelasomeran Elasomeran
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases; Vaccines
PIP number: EMEA-002893-PIP01-20-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Dispersion for injection
Decision date: 30/06/2022, Last updated: 29/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002826-PIP01-20-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 24/06/2022, Last updated: 29/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Brukinsa, zanubrutinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002354-PIP02-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 10/06/2022, Last updated: 29/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-002077-PIP01-16-M05, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 10/06/2022, Last updated: 29/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Comirnaty, Tozinameran
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002861-PIP02-20-M05, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Concentrate for dispersion for injection, Dispersion for injection
Decision date: 31/12/2021, Last updated: 26/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Beyfortus, Nirsevimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001784-PIP01-15-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 08/07/2022, Last updated: 23/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, Upadacitinib (ABT-494)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001741-PIP03-16-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet, Age-appropriate oral solid dosage form, Age-appropriate oral liquid dosage form
Decision date: 13/07/2022, Last updated: 23/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro, Ixazomib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001410-PIP02-17-M04, Route(s) of administration: Intravenous use, Oral use, Gastric use, Pharmaceutical form(s): Powder for solution for injection or infusion, Capsule, hard
Decision date: 08/07/2022, Last updated: 23/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Zavicefta, Ceftazidime, Avibactam
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001313-PIP01-12-M12, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 11/07/2022, Last updated: 23/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Heplisav B, Hepatitis B (rDNA) surface antigen adjuvanted
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001127-PIP02-11-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 08/07/2022, Last updated: 23/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Uro-nephrology
PIP number: EMEA-001943-PIP02-20-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 10/06/2022, Last updated: 21/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001943-PIP01-16-M07, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 10/06/2022, Last updated: 21/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, Inebilizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001911-PIP01-15-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion
Decision date: 10/06/2022, Last updated: 21/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Libtayo, Cemiplimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002007-PIP02-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 13/05/2022, Last updated: 17/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Fetcroja, Cefiderocol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002133-PIP01-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 13/05/2022, Last updated: 16/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Regkirona, Regdanvimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002961-PIP01-21-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Kisplyx, Lenvatinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001119-PIP03-19-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Reblozyl, Luspatercept
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001521-PIP01-13-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X