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116 results
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Opinion/decision on a Paediatric investigation plan (PIP): Pumarix, Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005(H5N1) like strain used (PR8-IBCDC-RG2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000178-PIP01-07-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 08/05/2015, Last updated: 15/06/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Arepanrix, Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000687-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for emulsion for injection
Decision date: 09/08/2010, Last updated: 07/10/2010, Compliance check: V, 12/12/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Prepandrix, Purified antigen fractions of inactivated split virion Influenza A/Vietnam/1194/2004 (H5N1) like strain used (NIBRG-14), Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000160-PIP01-07-M05, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 14/08/2019, Last updated: 21/09/2021, Compliance check: V, 31/01/2020 -
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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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Dacogen, Decitabine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000555-PIP01-09-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 09/08/2017, Last updated: 21/09/2021, Compliance check: V, 18/10/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Alprolix, eftrenonacog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000914-PIP01-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 18/03/2020, Last updated: 03/08/2020, Compliance check: V, 24/07/2020 -
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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: 04/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vidaza, azacitidine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001272-PIP02-13-M01, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Powder for suspension for injection, Powder for solution for infusion
Decision date: 02/10/2015, Last updated: 23/11/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Strimvelis, Autologous CD34+ cells transduced ex-vivo with retroviral vector (GIADAl) containing human adenosine deaminase gene from cDNA
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001289-PIP01-12-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Cell suspension for infusion
Decision date: 06/08/2014, Last updated: 22/08/2014, Compliance check: V, 14/11/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Gavreto, pralsetinib
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-002575-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 09/07/2021, Last updated: 22/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Mvabea, Multivalent, live, recombinant, non-replicating in human cells, Modified Vaccinia Ankara vectored vaccine, expressing the EBOV Mayinga glycoprotein, the Sudan virus Gulu GP, the Marburg virus Musoke GP, and the Taï Forest virus nucleoprotein [MVA-BN-Filo]
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases; Vaccines
PIP number: EMEA-002308-PIP01-17-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 19/08/2021, Last updated: 02/09/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Votubia, everolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000019-PIP02-07-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 22/01/2014, Last updated: 19/02/2014, Compliance check: V, 29/01/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Votubia, everolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000019-PIP08-12-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 31/10/2017, Last updated: 13/02/2018, Compliance check: V, 01/06/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Hetlioz, tasimelteon
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001531-PIP01-13-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral liquid dosage form
Decision date: 17/07/2018, Last updated: 27/11/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Isentress, Raltegravir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000279-PIP01-08-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Chewable tablet, Granules for oral suspension
Decision date: 15/06/2016, Last updated: 02/03/2018, Compliance check: V, 19/06/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Vyxeos liposomal (previously known as Vyxeos), daunorubicin, cytarabine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001858-PIP02-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for infusion
Decision date: 14/08/2019, Last updated: 20/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001207-PIP01-11-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab
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-001207-PIP02-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 28/01/2021, Last updated: 29/09/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cerdelga, Eliglustat (tartrate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000461-PIP02-11-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Praxbind, idarucizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001438-PIP01-13-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 17/04/2019, Last updated: 16/09/2021, Compliance check: V, 24/07/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Coagadex, Human coagulation factor X
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000971-PIP01-10-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection or infusion
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: V, 26/01/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Obizur, susoctocog alfa
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-000753-PIP02-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 19/12/2017, Last updated: 29/11/2021, Compliance check: X -
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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 -
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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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Xospata, Gilteritinib (as fumarate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002064-PIP01-16-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Film-coated tablet, Age-appropriate oral dosage form
Decision date: 17/03/2021, Last updated: 05/11/2021, Compliance check: X