caa a22 4500 445808381 CHVBK 20180317145203.0 cr unu---uuuuu 170323e20111201xx s 000 0 eng 10.1007/s00415-011-6126-6 doi (NATIONALLICENCE)springer-10.1007/s00415-011-6126-6 Requirements for generic antiepileptic medicines: a clinical perspective [Elektronische Daten] [Eugen Trinka, Günter Krämer, Martin Graf] Many antiepileptic drugs (AEDs) are now available as a generic product. This can potentially save the healthcare providers massive costs. Hence, governmental authorities have introduced rules and incentives for clinicians to switch from the original branded AED to a generic product. Clinicians and patients with epilepsy are reluctant to switch. The licensing of generic AEDs is based on the equation that bioavailability means therapeutic equivalence. However, from a clinical standpoint one has to consider several other relevant issues: (1) Do generic AEDs have the same efficacy, safety and quality? (2) Can generic AEDs be used as substitutions for brand AEDs? (3) Can generic products of AEDs be used interchangeably? (4) Does the generic AED manufacturer guarantee the long-term consistency of availability on the market? (4) Do generic AEDs reduce the costs, and—if so—are these costs worth any additional risk to patient's safety? This article reviews the clinical issues related to current bioequivalence, prescribability, and switchability of AEDs. Springer-Verlag, 2011 Antiepileptic drugs nationallicence Generics nationallicence Epilepsy nationallicence Health economy nationallicence Bioequivalence nationallicence Trinka Eugen Department of Neurology at the Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Ignaz Harrerstrasse 79, 5020, Salzburg, Austria aut Krämer Günter Swiss Epiklinik, Zurich, Switzerland aut Graf Martin Department of Neurology, Donauspital, Wien, Austria aut Journal of Neurology Springer-Verlag 258/12(2011-12-01), 2128-2132 0340-5354 258:12<2128 2011 258 415 https://doi.org/10.1007/s00415-011-6126-6 text/html Onlinezugriff via DOI 1 review-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s00415-011-6126-6 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Trinka Eugen Department of Neurology at the Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Ignaz Harrerstrasse 79, 5020, Salzburg, Austria aut NATIONALLICENCE 700 1- Krämer Günter Swiss Epiklinik, Zurich, Switzerland aut NATIONALLICENCE 700 1- Graf Martin Department of Neurology, Donauspital, Wien, Austria aut NATIONALLICENCE 773 0- Journal of Neurology Springer-Verlag 258/12(2011-12-01), 2128-2132 0340-5354 258:12<2128 2011 258 415 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer