2818 results
Keyword neurology Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Fycompa, perampanel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000467-PIP01-08-M15, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Oral suspension
Decision date: 03/12/2021, Last updated: 15/03/2023, Compliance check: XEMEA-000467-PIP01-08-M15 Neurology … perampanel Therapeutic area Neurology Decision number P/0521/2021 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tecfidera, dimethyl fumarate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000832-PIP01-10-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 15/05/2020, Last updated: 10/03/2023, Compliance check: V, 14/06/2021EMEA-000832-PIP01-10-M05 Neurology … fumarate Therapeutic area Neurology Decision number P/0177/2020 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Delandistrogene moxeparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002677-PIP01-19-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 08/07/2022, Last updated: 21/02/2023, Compliance check: XEMEA-002677-PIP01-19-M02 Neurology … Delandistrogene moxeparvovec NeurologyP/0230/2022EMEA-002677-PIP01-19-M02 Solution for infusion Treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Evrysdi, Risdiplam (RO7034067)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002070-PIP01-16-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral solution
Decision date: 26/11/2021, Last updated: 13/02/2023, Compliance check: XEMEA-002070-PIP01-16-M06 Neurology … Evrysdi Risdiplam (RO7034067) NeurologyP/0470/2021EMEA-002070-PIP01-16-M06 Powder for oral solution … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ganaxolone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002341-PIP01-18-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Age-appropriate oral liquid formulation
Decision date: 01/10/2021, Last updated: 13/02/2023, Compliance check: XEMEA-002341-PIP01-18-M02 Neurology … Key facts Ganaxolone NeurologyP/0404/2021EMEA-002341-PIP01-18-M02 Oral suspension Age-appropriate … -
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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: Neurology
PIP number: EMEA-001710-PIP02-14-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: XEMEA-001710-PIP02-14-M06 Neurology … hydrochloride) Therapeutic area Neurology Decision number P/0415/2021 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Solriamfetol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002184-PIP01-17-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 08/09/2021, Last updated: 13/01/2023, Compliance check: XEMEA-002184-PIP01-17-M01 Neurology … Key facts Solriamfetol NeurologyP/0394/2021EMEA-002184-PIP01-17-M01 Tablet Treatment of narcolepsy … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bivalent anti-human myostatin adnectin recombinant human IgG1-Fc fusion protein (RO7239361)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001793-PIP01-15-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection, Solution for injection in pre-filled syringe
Decision date: 29/01/2019, Last updated: 02/12/2022, Compliance check: XEMEA-001793-PIP01-15-M03 Neurology … RO7239361) Therapeutic area Neurology Decision number P/0043/2019 … -
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Opinion/decision on a Paediatric investigation plan (PIP): cenobamate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-002563-PIP02-19-M01, Route(s) of administration: Oral use, Parenteral use, Gastric use, Pharmaceutical form(s): Tablet, Film-coated tablet, Age-appropriate oral liquid dosage form, Age-appropriate dosage form for parenteral use
Decision date: 13/08/2021, Last updated: 14/09/2022, Compliance check: XEMEA-002563-PIP02-19-M01 Neurology … Key facts cenobamate NeurologyP/0300/2021EMEA-002563-PIP02-19-M01 Tablet Film-coated tablet … -
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Opinion/decision on a Paediatric investigation plan (PIP): Temelimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002127-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 12/08/2021, Last updated: 01/09/2022, Compliance check: XEMEA-002127-PIP01-17-M01 Neurology … Key facts Temelimab NeurologyP/0313/2021EMEA-002127-PIP01-17-M01 Solution for infusion Treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Vimpat, lacosamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000402-PIP03-17-M05, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Solution for infusion, Syrup
Decision date: 20/08/2021, Last updated: 31/08/2022, Compliance check: XEMEA-000402-PIP03-17-M05 Neurology … lacosamide Therapeutic area Neurology Decision number P/0349/2021 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ocrevus, ocrelizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000310-PIP03-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 13/08/2021, Last updated: 31/08/2022, Compliance check: XEMEA-000310-PIP03-10-M05 Neurology … ocrelizumab Therapeutic area Neurology Decision number P/0305/2021 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human heparan-N-sulfatase
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-001634-PIP01-14, Route(s) of administration: Intrathecal use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 30/01/2015, Last updated: 14/06/2022, Compliance check: XEMEA-001634-PIP01-14 Neurology … human heparan-N-sulfatase NeurologyP/0027/2015EMEA-001634-PIP01-14 Solution for injection/infusion … -
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Opinion/decision on a Paediatric investigation plan (PIP): arimoclomol citrate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-001748-PIP03-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 28/01/2021, Last updated: 10/06/2022, Compliance check: XEMEA-001748-PIP03-19 Neurology … Key facts arimoclomol citrate NeurologyP/0012/2021EMEA-001748-PIP03-19 Capsule, hard Treatment of … -
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Opinion/decision on a Paediatric investigation plan (PIP): (R)-1-(1-acryloylpiperidin-3-yl)-4-amino-3-(4-phenoxyphenyl)-1H-imidazo[4,5-c]pyridin-2(3H)-one (SAR442168)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-002566-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 14/08/2020, Last updated: 09/03/2022, Compliance check: XEMEA-002566-PIP01-19 Neurology … SAR442168) Therapeutic area Neurology Decision number P/0310/2020 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bumetanide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001303-PIP01-12-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid formulation
Decision date: 09/08/2021, Last updated: 03/02/2022, Compliance check: XEMEA-001303-PIP01-12-M04 Neurology … Key facts Bumetanide NeurologyP/0340/2021EMEA-001303-PIP01-12-M04 Age-appropriate oral liquid … -
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Opinion/decision on a Paediatric investigation plan (PIP): Translarna, Ataluren
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000115-PIP01-07-M11, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 10/05/2021, Last updated: 16/02/2022, Compliance check: XEMEA-000115-PIP01-07-M11 Neurology … Ataluren Therapeutic area Neurology Decision number P/0195/2021 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Briviact (in Italy: Nubriveo), Brivaracetam
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000332-PIP01-08-M16, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Oral solution, Solution for injection
Decision date: 09/04/2021, Last updated: 18/01/2022, Compliance check: XEMEA-000332-PIP01-08-M16 Neurology … Brivaracetam Therapeutic area Neurology Decision number P/0174/2021 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Efgartigimod alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002597-PIP01-19-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 17/03/2021, Last updated: 19/11/2021, Compliance check: XEMEA-002597-PIP01-19-M01 Neurology … Key facts Efgartigimod alfa NeurologyP/0072/2021EMEA-002597-PIP01-19-M01 Concentrate for solution … -
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Opinion/decision on a Paediatric investigation plan (PIP): Inebilizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001911-PIP01-15-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion
Decision date: 28/10/2020, Last updated: 24/11/2021, Compliance check: XEMEA-001911-PIP01-15-M03 Neurology … Inebilizumab Therapeutic area Neurology Decision number P/0428/2020 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Eladocagene exuparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002435-PIP01-18-M02, Route(s) of administration: Intracerebral use, Pharmaceutical form(s): Solution for infusion
Decision date: 17/03/2021, Last updated: 19/11/2021, Compliance check: XEMEA-002435-PIP01-18-M02 Neurology … exuparvovec Therapeutic area Neurology Decision number P/0074/2021 … -
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Opinion/decision on a Paediatric investigation plan (PIP): autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-family D (ALD), member 1 (ABCD1) from cDNA
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001244-PIP01-11-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 12/09/2018, Last updated: 16/09/2021, Compliance check: V, 04/09/2020EMEA-001244-PIP01-11-M02 Neurology … member 1 (ABCD1) from cDNA NeurologyP/0290/2018EMEA-001244-PIP01-11-M02 Dispersion for infusion Treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): lasmiditan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002166-PIP01-17-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Orodispersible tablet
Decision date: 29/01/2021, Last updated: 06/10/2021, Compliance check: XEMEA-002166-PIP01-17-M05 Neurology … lasmiditan Therapeutic area Neurology Decision number P/0056/2021 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Epidyolex, Cannabidiol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001964-PIP01-16-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 29/01/2021, Last updated: 06/10/2021, Compliance check: XEMEA-001964-PIP01-16-M03 Neurology … Cannabidiol Therapeutic area Neurology Decision number P/0033/2021 … -
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Opinion/decision on a Paediatric investigation plan (PIP): satralizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001625-PIP01-14-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 01/12/2020, Last updated: 27/09/2021, Compliance check: XEMEA-001625-PIP01-14-M06 Neurology … satralizumab Therapeutic area Neurology Decision number P/0477/2020 …