For help on how to get the results you want, see our search tips.
2669 results
Categories
Human Remove Human filter
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Eliquis, Apixaban
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000183-PIP01-08-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral liquid dosage form, Age-appropriate dosage form, other
Decision date: 20/05/2020, Last updated: 30/06/2023, Compliance check: V, 24/06/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Trulicity, dulaglutide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000783-PIP01-09-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection (pre-filled pen)
Decision date: 29/10/2021, 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): Nifurtimox
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-003134-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/03/2022, Last updated: 30/06/2023, Compliance check: V, 09/09/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): artesunate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-002710-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 14/08/2020, Last updated: 30/06/2023, Compliance check: V, 09/09/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-002869-PIP03-21, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 13/04/2022, Last updated: 30/06/2023, Compliance check: V, 09/09/2022 -
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): Agomelatine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001181-PIP01-11-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 17/03/2021, Last updated: 30/06/2023, Compliance check: V, 14/10/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Dopamine (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases; Neonatology-Paediatric Intensive Care
PIP number: EMEA-001105-PIP01-10-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 10/06/2023, Last updated: 30/06/2023, Compliance check: V, 14/10/2022 -
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): Briviact (in Italy: Nubriveo), Brivaracetam
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000332-PIP01-08-M16, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Oral solution, Solution for injection
Decision date: 09/04/2021, Last updated: 30/06/2023, Compliance check: V, 14/10/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, Baricitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001220-PIP03-16-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Tablet
Decision date: 11/08/2021, Last updated: 30/06/2023, Compliance check: V, 11/11/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Recombinant dimer of 6 kD early secretory antigenic target, recombinant 10 kD culture filtrate protein
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Diagnostic
PIP number: EMEA-001156-PIP01-11-M07, Route(s) of administration: Intradermal use, Pharmaceutical form(s): Solution for injection
Decision date: 15/07/2016, Last updated: 30/06/2023, Compliance check: V, 11/11/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Mekinist, Trametinib (dimethyl sulfoxide)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001177-PIP01-11-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral solution
Decision date: 23/10/2020, Last updated: 30/06/2023, Compliance check: V, 11/11/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tafinlar, dabrafenib mesilate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001147-PIP01-11-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Dispersible tablet
Decision date: 23/10/2020, Last updated: 30/06/2023, Compliance check: V, 11/11/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Moventig, Naloxegol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001146-PIP01-11-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral liquid dosage formulation
Decision date: 03/12/2021, Last updated: 30/06/2023, Compliance check: V, 11/11/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Lixiana, edoxaban tosilate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases; Haematology-Hemostaseology
PIP number: EMEA-000788-PIP02-11-M11, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral dosage form
Decision date: 29/10/2021, Last updated: 30/06/2023, Compliance check: V, 11/11/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Oteseconazole
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002392-PIP01-18-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 29/10/2021, Last updated: 30/06/2023, Compliance check: V, 16/12/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Vipidia, alogliptin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000496-PIP01-08-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/07/2020, Last updated: 30/06/2023, Compliance check: V, 11/11/2022 -
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): Jardiance, empagliflozin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000828-PIP01-09-M09, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 29/10/2021, Last updated: 30/06/2023, Compliance check: V, 16/12/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Trajenta, linagliptin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000498-PIP01-08-M10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 29/10/2021, Last updated: 30/06/2023, Compliance check: V, 16/12/2022 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Leniolisib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002989-PIP01-21-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Film-coated tablet, Granules
Decision date: 15/07/2022, Last updated: 29/06/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Dexmedetomidine hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-002758-PIP01-19-M02, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal film
Decision date: 08/07/2022, Last updated: 29/06/2023, 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)
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