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863 results
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Opinion/decision on a Paediatric investigation plan (PIP): Derivative of 4H-pyrazolo[3,4-d]pyrimidin-4-one (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001742-PIP01-14-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 14/08/2020, Last updated: 22/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Aztreonam (ATM), Avibactam (AVI) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002283-PIP01-17-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 13/05/2022, Last updated: 17/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Betmiga, Mirabegron (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000597-PIP03-15-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release granules for oral suspension, Prolonged-release tablet
Decision date: 25/05/2022, Last updated: 17/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001904-PIP03-18-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Film-coated tablet
Decision date: 13/05/2022, Last updated: 17/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Libtayo, Cemiplimab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002007-PIP02-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 13/05/2022, Last updated: 17/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): ketamine (hydrochloride), sufentanil citrate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: EMEA-001739-PIP02-16-M01, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray, solution
Decision date: 13/05/2022, Last updated: 17/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tirzepatide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002360-PIP01-18-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/05/2022, Last updated: 16/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (AMG 451) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-002886-PIP01-20-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/05/2022, Last updated: 16/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Remibrutinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-002582-PIP01-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Coated tablet
Decision date: 13/05/2022, Last updated: 16/05/2023, Compliance check: X -
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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-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002232-PIP02-19-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Coated tablet
Decision date: 13/05/2022, Last updated: 16/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fetcroja, Cefiderocol (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002133-PIP01-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 13/05/2022, Last updated: 16/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Regkirona, Regdanvimab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002961-PIP01-21-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): magnesium sulfate heptahydrate (BLI800), Sodium sulphate anhydrou, potassium sulfate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000816-PIP02-10-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Concentrate for oral solution
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zebinix, eslicarbazepine acetate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000696-PIP02-10-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Tablet
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Forxiga, dapagliflozin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000694-PIP02-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral dosage form
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tolvaptan (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism; Uro-nephrology
PIP number: EMEA-001231-PIP02-13-M09, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Oral suspension
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Reblozyl, Luspatercept (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001521-PIP01-13-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kisplyx, Lenvatinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001119-PIP03-19-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto, Venetoclax (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-002018-PIP02-16-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Tablet for oral suspension, Powder for oral suspension
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride (KH176) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002113-PIP01-16-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form, Capsule, hard
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bylvay, Odevixibat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002054-PIP01-16-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Mirikizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002208-PIP01-17-M02, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Voxzogo, Vosoritide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002033-PIP01-16-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Glutamine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001996-PIP02-16-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral powder
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adrenaline (epinephrine)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002749-PIP01-19-M01, Route(s) of administration: Nasal use, Pharmaceutical form(s): Nasal spray, solution
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X