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Opinion/decision on a Paediatric investigation plan (PIP): peginesatide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000646-PIP01-09-M01, Route(s) of administration: Intravenous and subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 24/10/2012, Last updated: 17/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): lucerastat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002095-PIP01-16-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid paediatric formulation
Decision date: 17/06/2020, Last updated: 17/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Human fibrinogen concentrate (BT524)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001931-PIP01-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection or infusion
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): ligelizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001811-PIP02-15-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/06/2020, Last updated: 17/03/2021, 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: Dermatology, Immunology-Rheumatology-Transplantation
PIP number: EMEA-001741-PIP04-17-M01, 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: 17/06/2020, Last updated: 17/03/2021, 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-M01, Route(s) of administration: Intralesional use, Pharmaceutical form(s): Suspension for injection
Decision date: 16/06/2020, Last updated: 17/03/2021, 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): satralizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001625-PIP01-14-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/06/2020, Last updated: 17/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): anifrolumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001435-PIP02-16-M01, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/06/2020, Last updated: 17/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): outer membrane vesicles (OMV) from n. meningitidis strain NZ 98/254, recombinant neisseria meningitis group B Protein 936-741, meningococcal group W-135 oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein, meningococcal group A oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein, meningococcal group C oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein, recombinant neisseria meningitis group B Protein 287-953, recombinant neisseria meningitis group B Protein 961c, meningococcal group Y oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein (MenABCWY)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001260-PIP01-11-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder and suspension for suspension 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): 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-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 22/06/2020, Last updated: 17/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz, Tofacitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000576-PIP01-09-M12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Prolonged-release film-coated tablet, Oral solution, Prolonged-release age-appropriate oral formulation
Decision date: 17/06/2020, Last updated: 17/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Brilique, ticagrelor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases, Haematology-Hemostaseology
PIP number: EMEA-000480-PIP01-08-M13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules for oral suspension, Orodispersible tablet
Decision date: 17/06/2020, Last updated: 17/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Briviact (in Italy: Nubriveo), Brivaracetam
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000332-PIP02-17-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral solution
Decision date: 12/06/2020, Last updated: 16/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Maralixibat chloride (LUM001)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001475-PIP03-17-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 25/05/2020, Last updated: 16/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Imlygic, talimogene laherparepvec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001251-PIP01-11-M04, Route(s) of administration: Intratumoral use, Pharmaceutical form(s): Solution for injection
Decision date: 13/05/2020, Last updated: 16/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Genvoya, elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001460-PIP01-13-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/05/2020, Last updated: 16/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Evenity, Romosozumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001075-PIP04-15-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/05/2020, Last updated: 16/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 2-iminobiotin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neonatology-Paediactric Intensive care
PIP number: EMEA-001070-PIP01-10-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 15/05/2020, Last updated: 16/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tecfidera, dimethyl fumarate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000832-PIP01-10-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 15/05/2020, Last updated: 16/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Trulicity, dulaglutide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000783-PIP01-09-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection (pre-filled pen)
Decision date: 13/05/2020, Last updated: 16/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Aflunov, Influenza virus surface antigens - A/turkey/Turkey/1/05 (H5N1)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000599-PIP01-09-M07, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 15/05/2020, Last updated: 16/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Methoxyflurane
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: EMEA-000334-PIP01-08-M09, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation vapour, liquid
Decision date: 13/05/2020, Last updated: 16/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Eliquis, Apixaban
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000183-PIP01-08-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral liquid dosage form, Age-appropriate dosage form, other
Decision date: 20/05/2020, Last updated: 16/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Eliquis, Apixaban
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000183-PIP02-12-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral liquid dosage form, Age-appropriate dosage form, other
Decision date: 20/05/2020, Last updated: 16/03/2021, Compliance check: X