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2760 results
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Opinion/decision on a Paediatric investigation plan (PIP): daprodustat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Uro-nephrology
PIP number: EMEA-001452-PIP01-13-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Tablet
Decision date: 08/07/2022, Last updated: 07/11/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Calcipotriol (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-001606-PIP02-14, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Medicated nail lacquer
Decision date: 10/07/2015, Last updated: 07/11/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lanthanum carbonate hydrate
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000637-PIP02-10-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Chewable tablet, Oral powder
Decision date: 02/12/2022, Last updated: 25/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, alder pollen, birch pollen, hazel pollen
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000662-PIP02-09-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
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): 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): aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, birch pollen
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000837-PIP01-10-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
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): aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, birch pollen, alder pollen, hazel pollen
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000838-PIP01-10-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
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): Resmetirom
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-003087-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form
Last updated: 20/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tislelizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002480-PIP01-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 17/04/2019, Last updated: 20/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Paxlovid, (1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2- trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-003081-PIP01-21-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral dosage form
Decision date: 01/12/2022, Last updated: 13/10/2023, 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): Durlobactam / sulbactam (SUL-DUR)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002807-PIP01-20-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 01/12/2022, Last updated: 13/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gadoquatrane (BAY 1747846)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Diagnostic
PIP number: EMEA-002778-PIP01-20-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 01/12/2022, 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): Setrusumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002169-PIP01-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for 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): 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): levonorgestrel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002474-PIP02-18-M01, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal delivery system
Decision date: 28/10/2022, Last updated: 12/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Efanesoctocog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002501-PIP01-18-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 10/10/2022, Last updated: 12/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): ritlecitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-002451-PIP01-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral formulation
Decision date: 28/10/2022, Last updated: 12/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gepotidacin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002443-PIP01-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Age appropriate oral formulation, Film-coated tablet
Decision date: 28/10/2022, Last updated: 12/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Entyvio, vedolizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000645-PIP04-20-M02, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion, Solution for injection
Decision date: 07/09/2023, Last updated: 12/10/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 3,6-diamino-2,5-bis{N-[(1R)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine (MB-102)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Diagnostic; Uro-nephrology
PIP number: EMEA-001983-PIP01-16-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 28/10/2022, Last updated: 05/10/2023, Compliance check: X