2888 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Date of authorisation: 22/01/2001, Revision: 33, Withdrawn, Last updated: 04/05/2023Symptoms Signs and Symptoms Neurologic Manifestations Dyskinesias … -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): Methylphenidate (hydrochloride) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-003189-PIP01-22-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Chewable tablet, Oral suspension
Decision date: 24/01/2023, Last updated: 09/11/2023, Compliance check: XEMEA-003189-PIP01-22-M01 Neurology … Methylphenidate (hydrochloride) NeurologyP/0057/2023EMEA-003189-PIP01-22-M01 Chewable tablet Oral suspension … -
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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: XEMEA-000716-PIP01-09-M05 Neurology … Siponimod (hemifumarate) NeurologyP/0531/2022EMEA-000716-PIP01-09-M05 Film-coated tablet Treatment … -
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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: XEMEA-002397-PIP01-18-M03 Neurology … Key facts Kesimpta Ofatumumab NeurologyP/0537/2022EMEA-002397-PIP01-18-M03 Solution for injection Treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Vumerity, Diroximel fumarate (BIIB098)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002685-PIP02-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Gastro-resistant capsule, hard
Decision date: 29/09/2022, Last updated: 20/09/2023, Compliance check: XEMEA-002685-PIP02-19-M01 Neurology … Diroximel fumarate (BIIB098) NeurologyP/0413/2022EMEA-002685-PIP02-19-M01 Gastro-resistant capsule … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rozanolixizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002681-PIP01-19-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 29/09/2022, Last updated: 20/09/2023, Compliance check: XEMEA-002681-PIP01-19-M01 Neurology … Key facts Rozanolixizumab NeurologyP/0410/2022EMEA-002681-PIP01-19-M01 Solution for injection Treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001990-PIP01-16-M05, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Oral solution
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: XEMEA-001990-PIP01-16-M05 Neurology … Fenfluramine hydrochloride NeurologyP/0390/2022EMEA-001990-PIP01-16-M05 Oral solution Treatment of … -
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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-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: XEMEA-001710-PIP02-14-M07 Neurology … hydrochloride) Therapeutic area Neurology Decision number P/0392/2022 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Vydura, Rimegepant
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002812-PIP02-20-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral lyophilisate
Decision date: 10/08/2022, Last updated: 31/08/2023, Compliance check: XEMEA-002812-PIP02-20-M01 Neurology … Key facts Vydura Rimegepant NeurologyP/0299/2022EMEA-002812-PIP02-20-M01 Oral lyophilisate Treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Eptinezumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002243-PIP01-17-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 10/08/2022, Last updated: 29/08/2023, Compliance check: XEMEA-002243-PIP01-17-M03 Neurology … Key facts Vyepti Eptinezumab NeurologyP/0341/2022EMEA-002243-PIP01-17-M03 Concentrate for solution … -
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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-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Orodispersible tablet
Decision date: 11/08/2022, Last updated: 30/08/2023, Compliance check: XEMEA-002166-PIP01-17-M06 Neurology … lasmiditan Therapeutic area Neurology Decision number P/0056/2021 … -
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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): Rimegepant
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002812-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Orodispersable Tablets
Decision date: 12/08/2020, Last updated: 01/08/2023, Compliance check: XEMEA-002812-PIP01-20 Neurology … Key facts Rimegepant NeurologyP/0285/2020EMEA-002812-PIP01-20 Orodispersable Tablets Prevention … -
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Opinion/decision on a Paediatric investigation plan (PIP): Wakix, pitolisant
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001176-PIP01-11-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/01/2021, Last updated: 30/06/2023, Compliance check: V, 20/05/2022EMEA-001176-PIP01-11-M06 Neurology … pitolisant Therapeutic area Neurology Decision number P/0057/2021 … -
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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: 30/06/2023, Compliance check: V, 14/10/2022EMEA-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): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP05-15-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 11/03/2022, Last updated: 30/06/2023, Compliance check: V, 14/10/2022EMEA-000876-PIP05-15-M05 Neurology … Eculizumab Therapeutic area Neurology Decision number P/0074/2022 … -
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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-M06, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Solution for infusion, Syrup
Decision date: 08/07/2022, Last updated: 23/06/2023, Compliance check: XEMEA-000402-PIP03-17-M06 Neurology … lacosamide Therapeutic area Neurology Decision number P/0247/2022 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, Inebilizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001911-PIP01-15-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion
Decision date: 10/06/2022, Last updated: 21/06/2023, Compliance check: XEMEA-001911-PIP01-15-M04 Neurology … Inebilizumab Therapeutic area Neurology Decision number P/0213/2022 …