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The EMA publishes an EPAR for every medicine granted a central marketing authorisation by the European Commission following an assessment by the EMA's Committee for Medicinal Products for Human Use (CHMP). EPARs are full scientific assessment reports of medicines authorised at a European Union level. You can find information including a public-friendly summary in question-and-answer format and Although there have been increasing reports of intentional gabapentin misuse, epidemiological evidence for the phenomenon is limited. The purpose of this study was to determine whether there are pharmacovigilance abuse signals for gabapentin. Using A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral, the European Medicines Agency (EMA) is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the European Union (EU). Gabapentin (Neurontin and associated names) has been approved in several Member States for the treatment of epileptic syndromes and several types of neuropathic pain. mber States have granted a marketing authorisation for Gabapentine Glenmark 100 mg, 300 mg and 400 mg hard capsules from Glenmark Pharmaceuticals Europe Limited. The product is indicated for: Epilepsy Gabapenti. Algorithms were developed to detect epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) (approved indications for gabapentinoids by the European Medicines Agency, with the exception of gabapentin for GAD) using data ± 1 year around the gabapentinoid prescription date. Redirecting to The European Medicines Agency approved gabapentin in 2006 for epilepsy and certain types of neuropathic pain (9) and the UK National Institute for Clinical Excellence (NICE) recommends gabapentin as a first-line treatment for all neuropathic pain (10). The aim of the study was to identify and assess cases of gabapentinoid misuse or dependence as reported to the European Medicines Agency’s EudraVigilance database, to identify the magnitude of this problem and the characteristics of these reactions. Periodic safety update report single assessments (PSUSAs) are single assessments of related periodic safety update reports (PSURs) for active substances contained in medicines authorised in the European Union (EU). Gabapentin is a gamma-amino acid that is cyclohexane substituted at position 1 by aminomethyl and carboxymethyl groups. Used for treatment of neuropathic pain and restless legs syndrome. It has a role as an anticonvulsant, a calcium channel blocker, an environmental contaminant and a xenobiotic. It is functionally related to a gamma-aminobutyric acid. The European Medicines Agency (EMA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and has provided guidance to marketing authorisation holders to avoid the presence of nitrosamine impurities. Introduction Gabapentinoids, pregabalin and gabapentin, are widely used for the treatment of neuropathic pain and epileptic disorders according to the United States (US) Food and Drug Administration (FDA). Both gabapentin and pregabalin have been approved by the European Medicine Agency (EMA) for neuropathic pain and generalized anxiety disorder, respectively. Additionally, some off-label uses According to the European Medicine Agency, gabapentin and pregabalin are additionally indicated for neuropathic pain and generalised anxiety disorder, respectively. Both are frequently prescribed off-label, particularly as adjunct analgesics for various pain-related indications. A waiver for gabapentin, prolonged-release tablet, oral use, the details of which are set out in the opinion of the Paediatric Committee of the European Medicines Agency annexed hereto, together with its appendices, is hereby granted. This section includes the European Medicines Agency's (EMA) product-specific bioequivalence guidance, which summarises in a standardised format the relevant study design principles for demonstration of bioequivalence. Objectives: The aim of the study was to identify and assess cases of gabapentinoid misuse or dependence as reported to the European Medicines Agency's EudraVigilance database, to identify the magnitude of this problem and the characteristics of these reactions. Both gabapentin and pregabalin have been approved by the European Medicine Agency (EMA) for neuropathic pain and generalized anxiety disorder, respectively. The European Commission granted a marketing authorisation valid throughout the European Union for Lyrica to Pfizer Limited on 6 July 2004. The marketing authorisation is valid for an unlimited period. For more information about treatment with Lyrica, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. ngdom (UK) and is currently marketed in 96 countries. In the European Union (EU), gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above; as monotherapy in the treatment of partial seizures with and without secondary
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