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169 results
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Opinion/decision on a Paediatric investigation plan (PIP): Lojuxta, Lomitapide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001124-PIP01-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form, other
Decision date: 10/09/2019, Last updated: 26/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Translarna, Ataluren
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000115-PIP02-09-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 04/11/2016, Last updated: 23/01/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Translarna, Ataluren
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000115-PIP01-07-M11, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 10/05/2021, Last updated: 16/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Oxervate, Cenegermin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-001729-PIP02-18, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 17/04/2019, Last updated: 25/06/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Glivec, imatinib mesilate
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-000463-PIP02-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 08/04/2011, Last updated: 12/05/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Glivec, imatinib mesilate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000463-PIP01-08-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Film-coated tablet
Decision date: 28/01/2012, Last updated: 23/02/2012, Compliance check: V, 09/03/2012 -
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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): Verzenios, abemaciclib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002342-PIP01-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 17/04/2019, Last updated: 02/04/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002342-PIP03-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 12/06/2019, Last updated: 07/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib
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-002342-PIP02-18, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 06/01/2020, Last updated: 09/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Talzenna, talazoparib
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-002066-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 09/06/2021, Last updated: 26/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Aimovig, erenumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001664-PIP02-15-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 19/06/2020, Last updated: 17/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Wakix, pitolisant
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001176-PIP01-11-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/01/2021, Last updated: 05/07/2021, Compliance check: X -
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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 -
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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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ajovy, fremanezumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001877-PIP01-15-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 04/12/2019, Last updated: 02/04/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro, Ixazomib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001410-PIP02-17-M03, Route(s) of administration: Intravenous use, Oral use, Gastric use, Pharmaceutical form(s): Powder for solution for injection or infusion, Capsule, hard
Decision date: 09/09/2020, Last updated: 14/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ondexxya, andexanet alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001902-PIP01-15-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 09/09/2020, Last updated: 01/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Doptelet, avatrombopag maleate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001136-PIP01-11-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral suspension
Decision date: 22/11/2019, Last updated: 12/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Doptelet, Avatrombopag
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001136-PIP02-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral suspension
Decision date: 09/12/2020, Last updated: 23/09/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP02-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 07/08/2015, Last updated: 17/12/2015, Compliance check: X -
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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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP04-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 08/10/2018, Last updated: 11/01/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): HyQvia, Human normal immunoglobulin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000872-PIP01-10-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for infusion
Decision date: 27/08/2015, Last updated: 13/11/2015, Compliance check: V, 30/10/2015 -
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Opinion/decision on a Paediatric investigation plan (PIP): Xofigo, radium (223Ra) dichloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001986-PIP01-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 03/07/2017, Last updated: 24/07/2017, Compliance check: X