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924 results
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
RPM: decision refers to a refusal on the application for modification of an agreed PIP Remove RPM: decision refers to a refusal on the application for modification of an agreed PIP filter
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Opinion/decision on a Paediatric investigation plan (PIP): Tremfya, Guselkumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001523-PIP03-18-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 28/10/2022, Last updated: 05/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Livmarli, Maralixibat chloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001475-PIP03-17-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 28/10/2022, Last updated: 05/10/2023, 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-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder and suspension for suspension for injection
Decision date: 28/10/2022, Last updated: 05/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Marstacimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002285-PIP02-19-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 28/10/2022, Last updated: 28/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002172-PIP02-17-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 28/10/2022, Last updated: 28/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fetcroja, Cefiderocol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002133-PIP01-17-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 28/10/2022, Last updated: 28/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Insulin human (NTRA-2112)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002116-PIP01-17-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral solution
Decision date: 28/10/2022, Last updated: 28/09/2023, 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-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 24/10/2022, Last updated: 28/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tofacitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-000576-PIP02-11-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral solution
Decision date: 17/03/2017, Last updated: 27/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir
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: 26/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Etrasimod L-arginine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002713-PIP01-19-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 29/09/2022, Last updated: 21/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): sotatercept
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002756-PIP01-19-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 29/09/2022, Last updated: 21/09/2023, 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-M02, Route(s) of administration: Nasal use, Pharmaceutical form(s): Nasal spray, solution
Decision date: 09/09/2022, Last updated: 21/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Plasma kallikrein inhibitor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002723-PIP01-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 27/09/2022, Last updated: 21/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Etranacogene dezaparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002722-PIP01-19-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/09/2022, Last updated: 21/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rozanolixizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002681-PIP01-19-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 29/09/2022, Last updated: 20/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vumerity, Diroximel fumarate (BIIB098)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002685-PIP02-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Gastro-resistant capsule, hard
Decision date: 29/09/2022, Last updated: 20/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zoliflodacin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002599-PIP01-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 09/09/2022, Last updated: 20/09/2023, 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-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules for oral suspension
Decision date: 09/09/2022, Last updated: 20/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Benlysta, belimumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000520-PIP02-13-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 09/09/2022, Last updated: 19/09/2023, Compliance check: X -
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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-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 19/09/2022, Last updated: 19/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Veyvondi, vonicog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001164-PIP01-11-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 07/09/2022, Last updated: 19/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, Baricitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001220-PIP07-20-M01, Route(s) of administration: Gastric use, Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form, Film-coated tablet
Decision date: 09/09/2022, Last updated: 19/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vocabria, Cabotegravir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001418-PIP01-13-M05, Route(s) of administration: Intramuscular use, Oral use, Pharmaceutical form(s): Age-appropriate oral dosage form, Film-coated tablet, Prolonged-release suspension for injection
Decision date: 09/09/2022, Last updated: 19/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, Inotuzumab ozogamicin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-001429-PIP01-13-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 09/09/2022, Last updated: 19/09/2023, Compliance check: X