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440 results
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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: 10/03/2023, Compliance check: V, 25/06/2021 -
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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): Lutathera, lutetium (177Lu) oxodotreotide
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-002950-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 03/12/2021, Last updated: 10/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dovprela (previously Pretomanid FGK), Pretomanid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002115-PIP01-17-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Tablet
Decision date: 03/12/2021, Last updated: 21/03/2023, Compliance check: X -
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Withdrawn application: Imcivree
setmelanotide, date of withdrawal: 22/04/2022, Post-authorisation, Last updated: 28/09/2022 -
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Summary of opinion: Imcivree
setmelanotide, opinion date: 21/07/2022, Positive, Last updated: 22/07/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Darzalex, Daratumumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002152-PIP03-19, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 18/03/2020, Last updated: 28/07/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Idefirix, Imlifidase
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002183-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 11/03/2022, Last updated: 23/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001032-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Film-coated tablet
Decision date: 09/08/2017, Last updated: 28/09/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001032-PIP01-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Film-coated tablet
Decision date: 03/12/2021, Last updated: 16/03/2023, Compliance check: X -
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Withdrawn application: Opsumit
macitentan, date of withdrawal: 08/11/2019, Post-authorisation, Last updated: 17/02/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan
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-001032-PIP03-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 09/07/2021, Last updated: 20/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Symkevi, tezacaftor, ivacaftor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001640-PIP01-14-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 30/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cresemba, Isavuconazonium sulfate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001301-PIP02-12-M04, Route(s) of administration: Intravenous use, Oral use, Pharmaceutical form(s): Powder for solution for infusion, Capsule, hard
Decision date: 03/12/2021, Last updated: 28/03/2023, Compliance check: X -
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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-M04, Route(s) of administration: Gastric use, Oral use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Cometriq, cabozantinib
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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Vimizim, Recombinant human N-acetylgalactosamine-6-sulfatase (BMN110)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000973-PIP01-10-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 30/03/2015, Last updated: 06/05/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Natpar, Recombinant parathyroid hormone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001526-PIP01-13-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
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): Lamzede, velmanase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001056-PIP02-12-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 23/10/2020, Last updated: 10/03/2023, Compliance check: V, 23/04/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ayvakyt, Avapritinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002358-PIP02-18-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pyrukynd, Mitapivat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002684-PIP01-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001915-PIP01-15-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 14/04/2021, Last updated: 18/01/2022, Compliance check: X -
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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