186 results
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Referral: Neurontin
gabapentin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 01/06/2006, EC decision date: 04/08/2006, Last updated: 06/09/2006Commission final decision Overview Gabapentin (Neurontin and associated … precise mechanism of action of gabapentin is not known Gabapentin is structurally related to … Non-Proprietary Name (INN): Gabapentin: Background information PDF … -
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Opinion/decision on a Paediatric investigation plan (PIP): gabapentin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: EMEA-001310-PIP01-12-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 19/07/2018, Last updated: 28/11/2018, Compliance check: XKey facts gabapentin PainP/0198/2018EMEA-001310-PIP01-12-M03 … paediatric investigation plan for gabapentin (EMEA-001310-PIP01-12-M03 … gabapentin … -
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Opinion/decision on a Paediatric investigation plan (PIP): gabapentin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology; Pain
PIP number: EMEA-002994-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 12/08/2021, Last updated: 12/09/2022, Compliance check: XKey facts gabapentin NeurologyPainP/0335/2021EMEA-002994-PIP01-21 … product specific waiver for gabapentin (EMEA-002994-PIP01-21) PDF … product specific waiver for gabapentin (EMEA-002994-PIP01-21) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Trazodone (hydrochloride), gabapentin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002263-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: XTrazodone (hydrochloride) gabapentin PainP/0089/2018EMEA-002263-PIP01-17 … trazodone (hydrochloride) / gabapentin (EMEA-002263- PIP01-17) PDF … trazodone (hydrochloride) / gabapentin (EMEA-002263-PIP01-17) 30 … -
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Press release: EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision; Aurobindo Pharma stopped from supplying irbesartan to the EU
Last updated: 15/10/2018under increased supervision; Aurobindo Pharma stopped from supplying … Aurobindo Pharma stopped from supplying … -
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Orphan designation: L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser (cibinetide) for: Treatment of sarcoidosis
Date of designation: 07/10/2013, Positive, Last updated: 31/10/2013affecting the nerves) included gabapentin. In some patients with neurosarcoidosis … affecting the nerves) included gabapentin. In some patients with neurosarcoidosis … -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 18 – 21 October 2004
Last updated: 19/10/2004gabapentin) and associated names was … regard to the indications. Gabapentin is authorised in some Member … A referral for Neurontin (gabapentin) and associated names was … -
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Referral: Didanosine
didanosine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/09/2013, EC decision date: 20/11/2013, Last updated: 10/12/2013was Didanosine reviewed? Aurobindo Pharma (Malta) Limited submitted … was Didanosine reviewed? Aurobindo Pharma (Malta) Limited submitted … administration France Aurobindo Pharma (Malta) Limited … -
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National expert: Maria Formosa Cassar, Medicines Authority (updated)
- Declaration of interests - 80.36 KB | PDF
- Curriculum Vitae - 22.17 KB | PDF
Authorisations (pertaining to MAH: Aurobindo Pharma Malta) and PV documentation. Analytical … -
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National expert: Marcel Maliepaard, Medicines Evaluation Board (updated)
- Declaration of interests - 80.01 KB | PDF
- Curriculum Vitae - 28.16 KB | PDF
Pharmacokinetic Model of Gabapentin Generic Drugs. Clin Pharmacol … and three generic 800 mg gabapentin tablets in healthy subjects … -
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National expert: Pieter Glerum, Medicines Evaluation Board (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 17.98 KB | PDF
a non-parametric PK model of gabapentin generic drugs. Glerum PJ … Pharmacokinetic Model of Gabapentin Generic Drugs. 31/01/2023 … -
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National expert: André Elferink, Medicines Evaluation Board (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 22.46 KB | PDF
analysis of topiramate and gabapentin. Eur J Clin Pharmacol. 2011 … -
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European Medicines Agency workshop on modelling in paediatric medicines
European Medicines Agency, London, UK, from 14/04/2008 to 15/04/2008, Last updated: 01/04/2008studies of midazolam and gabapentin PDF icon application/pdf … studies of Midazolam and Gabapentin Dr Viera Lukacova Simulations … -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 24-27 May 2006
CHMP, Last updated: 02/06/2006gabapentin) and associated names, from … harmonisation referral for Neurontin (gabapentin) and associated names, from … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2013
CHMP, Last updated: 20/09/2013Marketing-authorisation holder Aurobindo Pharma (Malta) Limited More … -
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National expert: Henrik Dahllof, Medical Products Agency (updated)
- Declaration of interests - 80.47 KB | PDF
- Curriculum Vitae - 20.49 KB | PDF
E, Olgart L, Stiller CO. Gabapentin reverses mechanical allodynia … -
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Human medicine European public assessment report (EPAR): Lyrica (updated)
pregabalin, Epilepsy; Anxiety Disorders; Neuralgia
Date of authorisation: 05/07/2004, Revision: 59, Authorised, Last updated: 17/03/2023 -
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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) (updated)
dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,
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, Revision: 13, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Pregabalin Pfizer (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 10/04/2014, Revision: 29, Authorised, Last updated: 20/03/2023 -
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Human medicine European public assessment report (EPAR): Efavirenz Teva (updated)
efavirenz, HIV Infections
Date of authorisation: 09/01/2012,
, Revision: 12, Authorised, Last updated: 03/03/2023
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Human medicine European public assessment report (EPAR): Instanyl
Fentanyl citrate, Pain; Cancer
Date of authorisation: 20/07/2009, Revision: 35, Authorised, Last updated: 17/01/2023 -
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Human medicine European public assessment report (EPAR): Stocrin (updated)
efavirenz, HIV Infections
Date of authorisation: 28/05/1999, Revision: 48, Authorised, Last updated: 22/02/2023 -
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva k.s. (updated)
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 27/02/2017,, Revision: 13, Withdrawn, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,, Revision: 9, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Lacosamide UCB
lacosamide, Epilepsies, Partial
Date of authorisation: 26/08/2019, Revision: 5, Authorised, Last updated: 25/01/2023