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Opinion/decision on a Paediatric investigation plan (PIP): Spesolimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-002475-PIP02-19-M02, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for infusion, Solution for injection
Decision date: 18/02/2022, Last updated: 17/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain, Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage), Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002359-PIP01-18-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 10/02/2022, Last updated: 17/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Maribavir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000353-PIP02-16-M02, Route(s) of administration: Oral use, Gastroenteral use, Pharmaceutical form(s): Tablet, Tablet for oral suspension, Powder for oral suspension
Decision date: 28/10/2022, Last updated: 17/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Evotaz, cobicistat, atazanavir (sulfate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001465-PIP01-13-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 31/01/2022, Last updated: 17/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sivextro, tedizolid (phosphate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001379-PIP01-12-M06, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Powder for concentrate for solution for infusion, Powder for oral suspension
Decision date: 24/02/2022, Last updated: 14/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cystadrops, Cysteamine hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-000322-PIP01-08-M06, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 03/02/2022, Last updated: 14/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Mylotarg, gemtuzumab ozogamicin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001733-PIP02-15-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 31/01/2022, Last updated: 14/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Nemolizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001624-PIP01-14-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 04/01/2022, Last updated: 14/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001501-PIP02-13-M07, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 31/01/2022, Last updated: 14/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rienso, Ferumoxytol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Uro-nephrology
PIP number: EMEA-000373-PIP02-09-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 13/04/2022, Last updated: 13/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Onglyza, Saxagliptin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000200-PIP01-08-M09, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 13/04/2022, Last updated: 13/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cannabidiol, delta-9-tetrahydrocannabinol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000181-PIP01-08-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Oromucosal spray
Decision date: 13/04/2022, Last updated: 13/04/2023, 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-M04, 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: 31/01/2022, Last updated: 12/04/2023, 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-M11, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 07/01/2022, Last updated: 12/04/2023, 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-M05, Route(s) of administration: Intralesional use, Pharmaceutical form(s): Solution for injection
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dexmedetomidine hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-002758-PIP01-19-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal film
Decision date: 07/01/2022, Last updated: 12/04/2023, 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: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001220-PIP01-11-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Film-coated tablet
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Giroctocogene fitelparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002724-PIP01-19-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 04/01/2022, Last updated: 12/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pyrukynd, Mitapivat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002684-PIP01-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Phenobarbital
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002532-PIP01-18-M02, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Oral suspension
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ayvakyt, Avapritinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002358-PIP02-18-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zolgensma, Onasemnogene abeparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002168-PIP01-17-M04, Route(s) of administration: Intravenous use, Intrathecal use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Trixeo Aerosphere, Budesonide, Formoterol (fumarate), Glycopyrronium bromide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002063-PIP01-16-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Pressurised inhalation, suspension
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vadadustat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001944-PIP01-16-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral formulation
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Takhzyro, Lanadelumab (DX-2930)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001864-PIP01-15-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 31/01/2022, Last updated: 05/04/2023, Compliance check: X