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36 results
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Opinion/decision on a Paediatric investigation plan (PIP): trandolapril
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002274-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 17/07/2018, Last updated: 28/11/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pyrimidinyl-aminopyridine dual leucine zipper kinase inhibitor (GDC-0134)
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Neurology
PIP number: EMEA-002469-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 22/03/2019, Last updated: 24/06/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 2-(2-(3-Butoxy-phenyl)-ethylamino)-N,N-dimethyl-acetamide hydrochloride
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Psychiatry
PIP number: EMEA-002519-PIP02-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 14/06/2019, Last updated: 07/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chloroprocaine hydrochloride
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Anaesthesiology
PIP number: EMEA-000639-PIP04-19, Route(s) of administration: Epidural use, Pharmaceutical form(s): Solution for injection
Decision date: 06/01/2020, Last updated: 04/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chloroprocaine hydrochloride
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Anaesthesiology
PIP number: EMEA-000639-PIP05-19, Route(s) of administration: Ocular use, Pharmaceutical form(s): Gel
Decision date: 06/01/2020, Last updated: 04/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human IgGlA monoclonal Fab antibody
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002766-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 15/07/2020, Last updated: 16/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Reparixin
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001693-PIP02-20, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Tablet, Solution for infusion
Decision date: 07/05/2021, Last updated: 11/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Perflubutane
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Diagnostic; Oncology
PIP number: EMEA-003037-PIP01-21, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for dispersion for injection
Decision date: 22/11/2021, Last updated: 20/02/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant Hepatitis B vaccine
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Vaccines
PIP number: EMEA-002157-PIP01-17, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 10/09/2019, Last updated: 23/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bilastine
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Dermatology; Oto-rhino-laryngology; Pneumology-allergology
PIP number: EMEA-000347-PIP05-20, Route(s) of administration: Oral use, Intramuscular use, Intravenous use, Pharmaceutical form(s): Oral solution, Orodispersible tablet, Solution for injection, Tablet
Decision date: 17/06/2020, Last updated: 04/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): RoActemra, tocilizumab
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000309-PIP06-21, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 29/10/2021, Last updated: 10/02/2023, Compliance check: X