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154 results
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Paediatric investigation plans Remove Paediatric investigation plans filter
PIP decision type
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) Remove RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) filter
PM: decision on the application for modification of an agreed PIP Remove PM: decision on the application for modification of an agreed PIP filter
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Opinion/decision on a Paediatric investigation plan (PIP): Libtayo, Cemiplimab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002007-PIP02-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 13/05/2022, Last updated: 17/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Fetcroja, Cefiderocol (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002133-PIP01-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 13/05/2022, Last updated: 16/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Regkirona, Regdanvimab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002961-PIP01-21-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Reblozyl, Luspatercept (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001521-PIP01-13-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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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-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto, Venetoclax (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-002018-PIP02-16-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Tablet for oral suspension, Powder for oral suspension
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bylvay, Odevixibat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002054-PIP01-16-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 13/05/2022, Last updated: 12/05/2023, 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-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Palynziq, Pegvaliase
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001951-PIP01-16-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Hemgenix, 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-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 25/03/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adtralza, Tralokinumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001900-PIP02-17-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rukobia, fostemsavir (tromethamine)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001687-PIP01-14-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Supemtek, Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype), Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype), Recombinant Influenza Hemagglutinin-strain B (Victoria lineage), Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage) (RIV4)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002418-PIP01-18-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection in pre-filled syringe
Decision date: 18/03/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), Dinutuximab beta
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001314-PIP01-12-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion, Powder and solvent for solution for injection, Powder for solution for infusion
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Holoclar, Ex vivo expanded autologous human corneal epithelium cells containing stem cells
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-001082-PIP02-11-M03, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Living tissue equivalent
Decision date: 11/03/2022, Last updated: 19/04/2023, 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-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/04/2022, Last updated: 19/04/2023, 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-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral dosage form, Capsule, hard, Film-coated tablet
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Quviviq, Daridorexant
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-002121-PIP03-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Film-coated tablet
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Yescarta, Axicabtagene ciloleucel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002010-PIP01-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Emgality, Galcanezumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001860-PIP03-16-M07, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/04/2022, Last updated: 19/04/2023, 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-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral liquid dosage form
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Truberzi, Eluxadoline
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001579-PIP01-13-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Nulibry, Fosdenopterin (ORGN001)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001491-PIP01-13-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: V, 15/10/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Spravato, Esketamine (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001428-PIP03-15-M02, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray, solution
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Galafold, Migalastat hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001194-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X