For help on how to get the results you want, see our search tips.
2431 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): Elafibranor (updated)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001857-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 12/08/2020, Last updated: 10/08/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Cometriq, cabozantinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001143-PIP01-11-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Tablet, Capsule, hard
Decision date: 19/07/2021, Last updated: 25/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta, darunavir, cobicistat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001280-PIP01-12-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 19/07/2021, Last updated: 25/07/2022, 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: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001523-PIP03-18-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 09/07/2021, Last updated: 22/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Vemlidy, Tenofovir alafenamide (as fumarate) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001584-PIP01-13-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age appropriate non-tablet formulation
Decision date: 09/07/2021, Last updated: 22/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Nemolizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001624-PIP01-14-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 09/07/2021, Last updated: 22/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Evenity, Romosozumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001075-PIP04-15-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 09/07/2021, Last updated: 22/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Invokana, canagliflozin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001030-PIP01-10-M09, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 09/07/2021, Last updated: 22/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tivicay, Dolutegravir (DTG) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000409-PIP01-08-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Age appropriate formulation for oral use, Film-coated tablet
Decision date: 09/07/2021, Last updated: 22/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Cotadutide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002712-PIP01-19-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/07/2021, Last updated: 18/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Garadacimab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002726-PIP01-19-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/07/2021, Last updated: 18/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Rilzabrutinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002438-PIP02-19-M01, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 08/07/2021, Last updated: 18/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002862-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 07/07/2021, Last updated: 18/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Trogarzo, Ibalizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002311-PIP01-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/07/2021, Last updated: 18/07/2022, 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, -gynacology-fertility-metabolism
PIP number: EMEA-002232-PIP02-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Coated tablet
Decision date: 07/07/2021, Last updated: 18/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Cotadutide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002287-PIP01-17-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 09/07/2021, Last updated: 18/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): MenQuadfi, Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, N. meningitidis serogroup C polysaccharide conjugated to tetanus toxoid, N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid, N. meningitidis serogroup W polysaccharide conjugated to tetanus toxoid (MenACYW) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001930-PIP01-16-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 29/07/2021, Last updated: 18/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Takhzyro, Lanadelumab (DX-2930) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001864-PIP01-15-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 07/07/2021, Last updated: 18/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Alpivab, Peramivir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001856-PIP02-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 07/07/2021, Last updated: 18/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Vaborem, meropenem trihydrate, vaborbactam (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001731-PIP01-14-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 09/07/2021, Last updated: 18/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Gardasil, human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: P/13/2010, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection, Suspension for injection in pre-filled syringe
Decision date: 22/01/2010, Last updated: 12/07/2022, Compliance check: V, 16/04/2010 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ cells transduced with lentiviral vector encoding the human beta-globin gene
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001933-PIP01-16-M01, Route(s) of administration: Intraosseous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 12/06/2020, Last updated: 01/07/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Isavuconazonium sulfate
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-001301-PIP01-12, Route(s) of administration: Intravenous use, Oral use, Pharmaceutical form(s): Powder for solution for infusion, Capsule, hard
Decision date: 14/06/2013, Last updated: 29/06/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tislelizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002480-PIP01-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 17/04/2019, Last updated: 27/06/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human beta-glucuronidase (rhGUS, UX003)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001540-PIP01-13-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 28/07/2016, Last updated: 16/06/2022, Compliance check: V, 11/12/2019