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MT H 0334 002 PAR.Pdf CMDh/305/2013 March 2018, Rev.02 Summary Public Assessment Report Generics Prucalopride Dexcel 1 mg film-coated tablets Prucalopride Dexcel 2 mg film-coated tablets [Prucalopride (as Succinate)] MT/H/0334/001-002/DC Date: 20th January 2020 Summary Public Assessment Report Generics Prucalopride Dexcel 1 mg film-coated tablets Prucalopride Dexcel 2 mg film-coated tablets Prucalopride 1 mg, 2mg film-coated tablets This is a summary of the public assessment report (PAR) for Prucalopride Dexcel 1 mg, 2mg film-coated tablets. It explains how Prucalopride Dexcel 1 mg, 2mg film-coated tablets was assessed and its authorisation recommended as well as its conditions of use. It is not intended to provide practical advice on how to use Prucalopride Dexcel 1 mg, 2mg film-coated tablets. For practical information about using Prucalopride Dexcel 1 mg, 2mg film-coated tablets, patients should read the package leaflet or contact their doctor or pharmacist. What is Prucalopride Dexcel 1 mg, 2mg film-coated tablets and what is it used for? Prucalopride Dexcel 1 mg, 2mg film-coated tablets is a ‘generic medicine’. This means that Prucalopride Dexcel 1 mg, 2mg film-coated tablets is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Resolor 1mg, 2mg film coated tablets. Prucalopride is used for the treatment of chronic constipation in adults in whom laxatives do not work well enough. Not for use in children and adolescents younger than 18 years. How does Prucalopride Dexcel 1 mg, 2mg film-coated tablets work? Prucalopride Dexcel belongs to a group of gut motility enhancing medicines (gastrointestinal prokinetics). It acts on the muscle wall of the gut, helping to restore the normal functioning of the bowel. How is Prucalopride Dexcel 1 mg, 2mg film-coated tablets used? The pharmaceutical form of Prucalopride Dexcel 1 mg, 2mg film-coated tablets is film-coated tablets and the route of administration is oral. Please read section 3 of the PL for detailed information on dosing recommendations, the route of administration, and the duration of treatment. The usual dose of Prucalopride Dexcel for most patients is one 2 mg tablet once a day. If you are older than 65 years or have severe liver disease, the starting dose is one 1 mg tablet once a day, which your doctor may increase to 2 mg once a day if needed. Your doctor may also recommend a lower dose of one 1 mg tablet daily if you have severe kidney disease. Prucalopride Dexcel is only for adults and should not be taken by children and dolescents up to 18 years. The medicine can only be obtained with a prescription. The medicine can be obtained without a prescription. PAR Scientific discussion 2/21 What benefits of Prucalopride Dexcel 1 mg, 2mg film-coated tablets have been shown in studies? Because Prucalopride Dexcel 1 mg, 2mg film-coated tablets is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Resolor 1mg, 2mg film coated tablets. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. What are the possible side effects of Prucalopride Dexcel 1 mg, 2mg film-coated tablets? Because Prucalopride Dexcel 1 mg, 2mg film-coated tablets is a generic medicine and is bioequivalent to the reference medicine, its benefits and possible side effects are taken as being the same as the reference medicine. For the full list of restrictions, see the package leaflet. Why is Prucalopride Dexcel 1 mg, 2mg film-coated tablets approved? It was concluded that, in accordance with EU requirements, Prucalopride Dexcel 1 mg, 2mg film-coated tablets has been shown to have comparable quality and to be bioequivalent/be comparable to Resolor 1mg, 2mg film coated tablets. Therefore, the Malta Medicines Authority decided that, as for Resolor 1mg, 2mg film coated tablets, the benefits are greater than its risk and recommended that it can be approved for use. What measures are being taken to ensure the safe and effective use of Prucalopride Dexcel 1 mg, 2mg film-coated tablets? A risk management plan has been developed to ensure that Prucalopride Dexcel 1 mg, 2mg film-coated tablets is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Prucalopride Dexcel 1 mg, 2mg film-coated tablets, including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously as well. Other information about Prucalopride Dexcel 1 mg, 2mg film-coated tablets The marketing authorisation for Prucalopride Dexcel 1 mg, 2mg film-coated tablets was granted on 07th January 2020. The full PAR for Prucalopride Dexcel 1 mg, 2mg film-coated tablets can be found on the website https://www.hma.eu/mriproductindex.html. For more information about treatment with Prucalopride Dexcel 1 mg, 2mg film-coated tablets, read the package leaflet or contact your doctor or pharmacist. This summary was last updated in 01-2020. PAR Scientific discussion 3/21 CMDh/223/2005 February 2014 Public Assessment Report Scientific discussion Prucalopride Dexcel 1 mg film-coated tablets Prucalopride Dexcel 2 mg film-coated tablets [Prucalopride (as Succinate)] MT/H/0334/001-002/DC Date: 20th January 2020 This module reflects the scientific discussion for the approval of Prucalopride Dexcel 1 mg, 2 mg film-coated tablets. The procedure was finalised at 23rd December 2019. For information on changes after this date please refer to the module ‘Update’. PAR Scientific discussion 4/21 I. INTRODUCTION “Based on the review of the quality, safety and efficacy data, the Member States have granted a marketing authorisation for Prucalopride Dexcel 1 mg, 2 mg film-coated tablets, from Dexcel Pharma. The product is indicated for: Prucalopride Dexcel is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.. A comprehensive description of the indications and posology is given in the SmPC.” “The marketing authorisation has been granted pursuant to Article 10(1) of Directive 2001/83/EC.” II. QUALITY ASPECTS II.1 Introduction 1mg: Film-coated tablet. White to off-white, round biconvex, film-coated tablets embossed with “P1” on one side. Excipients: Tablet core Lactose monohydrate Microcrystalline cellulose Silica colloidal anhydrous Magnesium stearate Tablet coating Hypromellose Titanium dioxide (E171) Lactose monohydrate Macrogol 4000 Triacetin Container system Aluminium/Aluminium blisters in cartons containing 14, 28 or 84 film-coated tablets. 2mg: Film-coated tablet. Pink, round biconvex, film-coated tablets embossed with “P2” on one side. Excipients: Tablet core Lactose monohydrate Microcrystalline cellulose Silica colloidal anhydrous Magnesium stearate PAR Scientific discussion 5/21 Tablet coating Hypromellose Titanium dioxide (E171) Lactose monohydrate Macrogol 4000 Triacetin Iron oxide red (E172) Indigo carmine aluminium lake (E132) Iron oxide yellow (E172) Container system Aluminium/Aluminium blisters in cartons containing 14, 28 or 84 film-coated tablets. II.2 Drug Substance The active substance, Prucalopride succinate is not described in the Ph. Eur. An ASMF is being submitted in support of the application. One source has been proposed for the manufacture of the drug substance. The control tests and specifications for drug substance product are adequately drawn up. Stability studies have been performed with the drug substance. No significant changes in any parameters were observed. The proposed provisional retest period of 30 months (at no special storage conditions) is acceptable based upon the submitted stability data to-date. II.3 Medicinal Product The development of the product has been described, the choice of excipients is justified, and their functions explained. The pharmaceutical development has in general been adequately described. A BE study has been conducted on the 2mg strength and a BCS based biowaiver is being claimed for the 1mg strength. In-vitro data supports the BE study and the requested BCS biowaiver. The manufacturing process is considered as non-standard due to the low content of the active ingredient and has been described with sufficient details. Adequate process validation data has been provided. The product specifications cover appropriate parameters for this dosage form. Validations of the analytical methods have been presented. Batch analysis has been performed on three batches for each strength at the currently proposed commercial batch size. The batch analysis results show that the finished products meet the specifications proposed. The conditions used in the stability studies are according to the ICH stability guideline. The control tests and specifications for drug product are adequately drawn up. No significant changes in any parameters were observed. The currently proposed shelf-life of 24 months with no special storage conditions for the drug product can be accepted based upon the submitted stability data to-date. III. NON-CLINICAL ASPECTS The applicant has shown data to support the procedure submission marketing authorisation of Prucalopride 1 and 2 mg film coated tablets in accordance with Article 10(1) of Directive 2001/83/EC. The applicant’s Prucalopride 1 and 2 mg film coated tablets for oral use are the generic version of RESOLOR® (prucalopride succinate) film-coated tablet, 1 and 2 mg, Sanico NV, Belgium. In this submission, the applicant seeks approval of Prucalopride 1 and 2 mg film coated tablets for the treatment of chronic idiopathic constipation in adults in whom laxatives failed to provide adequate relief. PAR Scientific discussion 6/21 Since prucalopride has been marketed for more than 10 years within the European Community, comprehensive information exists on its biochemistry, pharmacology, toxicity (safety) and clinical use. The purpose of this nonclinical overview is to evaluate possible toxicological properties of the medicinal product under question through published scientific literature.
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