For help on how to get the results you want, see our search tips.
2634 results
Medicine
Paediatric investigation plans Remove Paediatric investigation plans filter
Shortages Remove Shortages filter
Categories
Human Remove Human filter
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Derivative of 4H-pyrazolo[3,4-d]pyrimidin-4-one (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001742-PIP01-14-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 14/08/2020, Last updated: 22/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Aztreonam (ATM), Avibactam (AVI) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002283-PIP01-17-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for 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): Betmiga, Mirabegron (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000597-PIP03-15-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release granules for oral suspension, Prolonged-release tablet
Decision date: 25/05/2022, Last updated: 17/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001904-PIP03-18-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Film-coated tablet
Decision date: 13/05/2022, Last updated: 17/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Libtayo, Cemiplimab (updated)
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): ketamine (hydrochloride), sufentanil citrate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: EMEA-001739-PIP02-16-M01, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray, solution
Decision date: 13/05/2022, Last updated: 17/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tirzepatide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002360-PIP01-18-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/05/2022, Last updated: 16/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Zynteglo, betibeglogene autotemcel (updated)
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001665-PIP01-14-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion 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): Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (AMG 451) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-002886-PIP01-20-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/05/2022, Last updated: 16/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Remibrutinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-002582-PIP01-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Coated tablet
Decision date: 13/05/2022, Last updated: 16/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Bis-choline tetrathiomolybdate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002232-PIP02-19-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Coated tablet
Decision date: 13/05/2022, Last updated: 16/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Fetcroja, Cefiderocol (updated)
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 (updated)
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): magnesium sulfate heptahydrate (BLI800), Sodium sulphate anhydrou, potassium sulfate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000816-PIP02-10-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Concentrate for oral solution
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Zebinix, eslicarbazepine acetate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000696-PIP02-10-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Tablet
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Forxiga, dapagliflozin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000694-PIP02-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral dosage form
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tolvaptan (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism; Uro-nephrology
PIP number: EMEA-001231-PIP02-13-M09, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Oral suspension
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 (updated)
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Kisplyx, Lenvatinib (updated)
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): Venclyxto, Venetoclax (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-002018-PIP02-16-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Tablet for oral suspension, Powder for oral suspension
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride (KH176) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002113-PIP01-16-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form, 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): Bylvay, Odevixibat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002054-PIP01-16-M03, 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): (R)-2-(1-(6-Amino-5-chloropyrimidine-4-carboxamido)ethyl)-N-(5-chloro-4-(trifluoromethyl)pyridin-2-yl)thiazole-5-carboxamide (DAY101)
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-002763-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Tablet
Decision date: 22/12/2020, Last updated: 05/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): abelacimab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003017-PIP01-21, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for injection
Decision date: 13/04/2022, Last updated: 25/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Mirikizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002208-PIP01-17-M02, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X