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Metylofenidat – Wikipedia, wolna encyklopedia

ЭТИЛФЕНИДАТ Poland

Амфетамин телеграмм Бельско-Бяла

On 25 July , the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union EU regarding the authorisation of the medicine Methylphenidate Sandoz. It has been available since the s as both immediate-release tablets and capsules, which release methylphenidate straight away, and as modified-release tablets that release some or all of the active substance more slowly over several hours. However, the Member States were not able to reach an agreement and the Danish medicines regulatory agency referred the matter to the CHMP for arbitration on 21 December The grounds for the referral were objections raised by Germany and the Netherlands, which considered that the bioequivalence study carried out under fed conditions did not show that Methylphenidate Sandoz was bioequivalent for the immediate-release phase to its reference product. As the product information states that the tablet can be taken with or without food, a bioequivalence study in fed conditions was required to grant the marketing authorisation. Two medicines are bioequivalent if they produce the same levels of the active substance in the body. Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the failure to show bioequivalence between Methylphenidate Sandoz and its reference medicine in the immediate-release phase under fed conditions were due to differences between patients in the effects of a high-fat meal on the way medicines are handled by the body, and not to differences between the formulations of the two medicinal products , and that bioequivalence to the reference medicinal product has been shown. The CHMP therefore concluded that the benefits of Methylphenidate Sandoz outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States. Requirements for demonstration of bioequivalence for generics of biphasic modified release formulations for oral use. This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure , on the grounds of a potential serious risk to public health. Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Methylphenidate Sandoz. Table of contents Overview Key facts All documents. Current status:. European Commission final decision. Expand section Collapse section. The European Commission issued a decision on this opinion on 09 October Key facts. Article 29 4 referrals. All documents. List item. More information on Methylphenidate Sandoz. How useful was this page? View 1 rating. Your name. Tell us more. Leave this field blank. International non-proprietary name INN or common name. Article 29 4 referrals This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure , on the grounds of a potential serious risk to public health.