200 results
Categories
Human Remove Human filter
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Vitrakvi, Larotrectinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001971-PIP03-18-M01, Route(s) of administration: Gastric use, Oral use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 17/03/2021, Last updated: 05/11/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Vitrakvi, Larotrectinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001971-PIP02-16-M03, Route(s) of administration: Gastric use, Oral use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 17/03/2021, Last updated: 05/11/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Zeposia, Ozanimod (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001710-PIP04-17-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral liquid dosage form
Decision date: 18/02/2021, Last updated: 08/10/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Lartruvo, Olaratumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001760-PIP01-15-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/03/2019, Last updated: 08/10/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Kesimpta, ofatumumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002397-PIP01-18-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 29/01/2021, Last updated: 06/10/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Xofluza, Baloxavir marboxil
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002440-PIP01-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules for oral suspension
Decision date: 29/01/2021, Last updated: 06/10/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Skyrizi, Risankizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001776-PIP02-17-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection, Age-appropriate pharmaceutical form
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Alofisel, darvadstrocel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001561-PIP01-13-M02, Route(s) of administration: Other use, Pharmaceutical form(s): Suspension for injection
Decision date: 27/01/2021, Last updated: 06/10/2021, 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-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 27/01/2021, Last updated: 06/10/2021, 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-M10, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 27/01/2021, Last updated: 29/09/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP01-10-M07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 28/01/2021, Last updated: 29/09/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Mayzent, Siponimod (hemifumarate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000716-PIP01-09-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 28/01/2021, Last updated: 29/09/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Alunbrig, brigatinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002296-PIP01-17-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate liquid dosage form, Film-coated tablet
Decision date: 09/12/2020, Last updated: 28/09/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Bavencio, avelumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001849-PIP02-15-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/12/2020, Last updated: 27/09/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Crysvita, Burosumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001659-PIP01-15-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 21/12/2020, Last updated: 27/09/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Orkambi, Lumacaftor, ivacaftor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001582-PIP01-13-M10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 22/12/2020, Last updated: 27/09/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Veyvondi, vonicog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001164-PIP01-11-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 04/12/2020, Last updated: 23/09/2021, Compliance check: X -
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-PIP03-14-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/12/2020, Last updated: 23/09/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Revestive, teduglutide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000482-PIP01-08-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 01/12/2020, Last updated: 23/09/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Vaxchora, Cholera vaccine, live attenuated, oral (strain CVD 103-HgR)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001490-PIP01-13-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension, Age-appropriate oral liquid dosage form
Decision date: 22/12/2020, Last updated: 22/09/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Harvoni, Sofosbuvir, ledipasvir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001411-PIP01-12-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form, Age-appropriate dosage form, other
Decision date: 16/03/2017, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Humenza, Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000669-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for injection
Decision date: 04/01/2019, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Sovaldi, Sofosbuvir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001276-PIP01-12-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form, Other
Decision date: 15/06/2018, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Strensiq, asfotase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000987-PIP01-10-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/05/2019, Last updated: 21/09/2021, Compliance check: V, 18/10/2019 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Maviret, glecaprevir, pibrentasvir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001832-PIP01-15-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid dosage form
Decision date: 17/04/2019, Last updated: 21/09/2021, Compliance check: V, 11/12/2019