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221 results
Medicine
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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-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 30/12/2022, Last updated: 13/11/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, Upadacitinib (ABT-494) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology; Immunology-Rheumatology-Transplantation
PIP number: EMEA-001741-PIP02-16-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet, Age-appropriate oral pharmaceutical form
Decision date: 06/12/2022, Last updated: 13/11/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Skyrizi, Risankizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001776-PIP01-15-M01, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection, Age-appropriate dosage form for parenteral use
Decision date: 02/12/2022, Last updated: 13/11/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xenleta, Lefamulin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002075-PIP01-16-M03, Route(s) of administration: Intravenous use, Oral use, Pharmaceutical form(s): Concentrate for solution for infusion, Age-appropriate oral solid dosage form, Coated tablet
Decision date: 30/12/2022, Last updated: 13/11/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sirturo, bedaquiline fumarate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000912-PIP01-10-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules
Decision date: 16/11/2022, Last updated: 13/11/2023, 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-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/12/2022, Last updated: 25/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Jcovden (previously COVID-19 Vaccine Janssen), COVID-19 vaccine (Ad26.COV2-S (recombinant))
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases; Vaccines
PIP number: EMEA-002880-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection in cartridge
Decision date: 30/12/2022, Last updated: 13/10/2023, 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-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 30/12/2022, Last updated: 13/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Oxbryta, Voxelotor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002356-PIP02-20-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 02/12/2022, Last updated: 13/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Leqvio, Inclisiran sodium
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002214-PIP01-17-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 02/12/2022, Last updated: 13/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sarclisa, Isatuximab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002205-PIP01-17-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 02/12/2022, Last updated: 13/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Imvanex, Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001161-PIP02-11-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 30/12/2022, Last updated: 13/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Libmeldy, atidarsagene autotemcel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001765-PIP02-15-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 18/10/2022, Last updated: 05/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kerendia, Finerenone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001623-PIP01-14-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral (liquid or solid) dosage form
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): 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): 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): 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): 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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Evkeeza, Evinacumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002298-PIP01-17-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Piqray, Alpelisib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002016-PIP03-19-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 30/09/2022, Last updated: 18/09/2023, Compliance check: X