For help on how to get the results you want, see our search tips.
2709 results
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Etrasimod L-arginine (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002713-PIP01-19-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 29/09/2022, Last updated: 21/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): sotatercept (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002756-PIP01-19-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 29/09/2022, Last updated: 21/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Adrenaline (epinephrine) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002749-PIP01-19-M02, Route(s) of administration: Nasal use, Pharmaceutical form(s): Nasal spray, solution
Decision date: 09/09/2022, Last updated: 21/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Plasma kallikrein inhibitor (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002723-PIP01-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 27/09/2022, Last updated: 21/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Etranacogene dezaparvovec (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002722-PIP01-19-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/09/2022, Last updated: 21/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Rozanolixizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002681-PIP01-19-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 29/09/2022, Last updated: 20/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Vumerity, Diroximel fumarate (BIIB098) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002685-PIP02-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Gastro-resistant capsule, hard
Decision date: 29/09/2022, Last updated: 20/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Zoliflodacin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002599-PIP01-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 09/09/2022, Last updated: 20/09/2023, 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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Benlysta, belimumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000520-PIP02-13-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 09/09/2022, Last updated: 19/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Lojuxta, Lomitapide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001124-PIP01-10-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 19/09/2022, Last updated: 19/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Veyvondi, vonicog alfa (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001164-PIP01-11-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 07/09/2022, Last updated: 19/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, Baricitinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001220-PIP07-20-M01, Route(s) of administration: Gastric use, Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form, Film-coated tablet
Decision date: 09/09/2022, Last updated: 19/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Vocabria, Cabotegravir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001418-PIP01-13-M05, Route(s) of administration: Intramuscular use, Oral use, Pharmaceutical form(s): Age-appropriate oral dosage form, Film-coated tablet, Prolonged-release suspension for injection
Decision date: 09/09/2022, Last updated: 19/09/2023, 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): Tremfya, Guselkumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001523-PIP04-19-M01, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection, Solution for injection in pre-filled syringe, Solution for injection in pre-filled pen
Decision date: 09/09/2022, Last updated: 19/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Roxadustat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001557-PIP01-13-M06, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Film-coated tablet
Decision date: 09/09/2022, Last updated: 19/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Descovy, emtricitabine, tenofovir alafenamide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001577-PIP02-14-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Film-coated tablet
Decision date: 09/09/2022, Last updated: 19/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Epcoritamab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002907-PIP01-20-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for injection, Solution for injection
Decision date: 29/09/2022, Last updated: 19/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Evkeeza, Evinacumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002298-PIP01-17-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tremelimumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002029-PIP01-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Imfinzi, durvalumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002028-PIP01-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine hydrochloride (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001990-PIP01-16-M05, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Oral solution
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Piqray, Alpelisib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002016-PIP03-19-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 30/09/2022, Last updated: 18/09/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Anti-CD7 mAb conjugated to ricin toxin A chain, Anti-CD3 mAb conjugated to ricin toxin A chain (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002087-PIP01-16-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X