2784 results
Keyword neurology Remove keyword
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Human medicine European public assessment report (EPAR): NeuroBloc
botulinum toxin type B, Torticollis
Date of authorisation: 22/01/2001, Revision: 33, Authorised, Last updated: 16/11/2022Symptoms Signs and Symptoms Neurologic Manifestations Dyskinesias … -
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Human medicine European public assessment report (EPAR): Exparel liposomal
bupivacaine, Acute Pain
Date of authorisation: 16/11/2020, Revision: 1, Authorised, Last updated: 14/11/2022Symptoms Signs and Symptoms Neurologic Manifestations Pain Acute … -
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Opinion/decision on a Paediatric investigation plan (PIP): Carisbamate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: Carisbamate, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Oral suspension, Intravenous formulation
Decision date: 09/06/2009, Last updated: 22/11/2021, Compliance check: XCarisbamate Neurology … Key facts Carisbamate NeurologyP/108/2009Carisbamate Film-coated tablet Oral suspension … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fampridine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: Fampridine, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 30/10/2010, Last updated: 25/11/2010, Compliance check: XFampridine Neurology … Key facts Fampridine NeurologyP/213/2010Fampridine Prolonged-release tablet … -
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Opinion/decision on a Paediatric investigation plan (PIP): Cladribine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: Cladribine, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 19/05/2009, Last updated: 09/07/2009, Compliance check: XCladribine Neurology … Cladribine Therapeutic area Neurology Decision number P/101/2009 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Sifrol, pramipexole dihydrochloride monohydrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: Pramipexole dihydrochloride monohydrate, Route(s) of administration: Oral use, Pharmaceutical form(s): Immediate Release Tablet
Decision date: 05/03/2010, Last updated: 19/04/2010, Compliance check: Xdihydrochloride monohydrate Neurology … monohydrate Therapeutic area Neurology Decision number P/27/2010 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Circadin, melatonin
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: Melatonin (Circadin), Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 24/03/2009, Last updated: 18/05/2009, Compliance check: XMelatonin (Circadin) Neurology … melatonin Therapeutic area Neurology Decision number P/49/2009 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Mirapexin, pramipexole dihydrochloride monohydrate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: Pramipexole dihydrochloride monohydrate, Route(s) of administration: Oral use, Pharmaceutical form(s): Immediate Release Tablet
Decision date: 12/09/2008, Last updated: 10/10/2008, Compliance check: Xdihydrochloride monohydrate Neurology … monohydrate Therapeutic area Neurology Decision number P/75/2008 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Plegridy, peginterferon beta-1a (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001129-PIP01-11-M05, Route(s) of administration: Subcutaneous use, Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 22/08/2022, Last updated: 21/03/2023, Compliance check: XEMEA-001129-PIP01-11-M05 Neurology … beta-1a Therapeutic area Neurology Decision number P/0359/2022 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine hydrochloride (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001990-PIP01-16-M04, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Oral solution
Decision date: 02/12/2021, Last updated: 21/03/2023, Compliance check: XEMEA-001990-PIP01-16-M04 Neurology … hydrochloride Therapeutic area Neurology Decision number P/0502/2021 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fycompa, perampanel (updated)
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 … Key facts Fycompa perampanel NeurologyP/0521/2021EMEA-000467-PIP01-08-M15 Tablet Oral suspension Treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): cerliponase alfa (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001362-PIP01-12-M03, Route(s) of administration: Intracerebral use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 05/09/2016, Last updated: 10/03/2023, Compliance check: V, 26/02/2021EMEA-001362-PIP01-12-M03 Neurology … Key facts cerliponase alfa NeurologyP/0248/2016EMEA-001362-PIP01-12-M03 Concentrate for solution … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tecfidera, dimethyl fumarate (updated)
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 … Tecfidera dimethyl fumarate NeurologyP/0177/2020EMEA-000832-PIP01-10-M05 Capsule, hard Treatment of … -
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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): leriglitazone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002106-PIP01-16-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: XEMEA-002106-PIP01-16-M01 Neurology … Key facts leriglitazone NeurologyP/0412/2021EMEA-002106-PIP01-16-M01 Oral suspension Treatment … -
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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-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: XEMEA-001860-PIP03-16-M06 Neurology … facts Emgality Galcanezumab NeurologyP/0449/2021EMEA-001860-PIP03-16-M06 Solution for injection Prevention … -
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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 … Ozanimod (hydrochloride) NeurologyP/0415/2021EMEA-001710-PIP02-14-M06 Capsule, hard Age-appropriate … -
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Human medicine European public assessment report (EPAR): Dynastat
parecoxib sodium, Pain, Postoperative
Date of authorisation: 22/03/2002, Revision: 32, Authorised, Last updated: 17/08/2022Complications Signs and Symptoms Neurologic Manifestations Pain Pain … -
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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 … fusion protein (RO7239361) NeurologyP/0043/2019EMEA-001793-PIP01-15-M03 Solution for injection Solution … -
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Opinion/decision on a Paediatric investigation plan (PIP): Phenobarbital
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-002532-PIP01-18-M01, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Oral suspension
Decision date: 13/08/2021, Last updated: 14/09/2022, Compliance check: XEMEA-002532-PIP01-18-M01 Neurology … Key facts Phenobarbital NeurologyP/0301/2021EMEA-002532-PIP01-18-M01 Oral suspension Treatment … -
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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 …