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144 results
Medicine
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PIP decision type
PM: decision on the application for modification of an agreed PIP Remove PM: decision on the application for modification of an agreed PIP filter
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Remove P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter
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Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology; Immunology-Rheumatology-Transplantation
PIP number: EMEA-001741-PIP04-17-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form, Age-appropriate oral solid dosage form, Prolonged-release capsule, Prolonged-release tablet
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): Rinvoq, upadacitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001741-PIP01-14-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Age-appropriate oral liquid dosage form, Prolonged-release tablet
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): Palforzia, defatted powder of Arachis hypogaea L., semen (peanuts)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001734-PIP01-14-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral powder, Capsule, hard
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): Delstrigo, doravirine, lamivudine, tenofovir disoproxil (fumarate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001695-PIP01-14-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules
Decision date: 12/04/2021, Last updated: 18/01/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pifeltro, doravirine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001676-PIP01-14-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules
Decision date: 12/04/2021, Last updated: 18/01/2022, Compliance check: X -
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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): Ilumetri, tildrakizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001451-PIP01-13-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 17/03/2021, Last updated: 26/11/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibrance, palbociclib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002146-PIP01-17-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral dosage form, Capsule, hard, Film-coated tablet
Decision date: 17/03/2021, Last updated: 19/11/2021, 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): Imfinzi, durvalumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002028-PIP01-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
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): 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): 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 -
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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 -
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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 -
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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 -
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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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Biktarvy, bictegravir, emtricitabine, tenofovir alafenamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001766-PIP01-15-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Film-coated tablet
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): VeraSeal, human fibrinogen, human thrombin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001598-PIP01-13-M03, Route(s) of administration: Epilesional use, Pharmaceutical form(s): Solution for sealant
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: X -
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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 -
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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 -
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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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Evarrest, human fibrinogen, human thrombin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001149-PIP01-11-M06, Route(s) of administration: Epilesional use, Pharmaceutical form(s): Solution for sealant, Sealant matrix
Decision date: 27/01/2021, 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: 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): 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 -
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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