Decentralised Procedure. Public Assessment Report

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1 Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report ben-u-ron direkt Erdbeer/Vanille 250/500 mg Granulat in Beuteln ben-u-ron direkt Cappuccino 500/1000 mg Granulat in Beuteln Paracetamol DE/H/2690/ /DC Applicant: Losan Pharma GmbH Reference member state: DE The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health. 1/6 Public AR

2 Table of content Page 1. EXECUTIVE SUMMARY Problem statement About the product General comments on compliance with GMP, GLP, GCP and agreed ethical principles SCIENTIFIC OVERVIEW AND DISCUSSION Quality aspects Nonclinical aspects Clinical aspects BENEFIT RISK ASSESSMENT... 6 The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health. 2/6 Public AR

3 Proposed name of the medicinal product in the RMS INN (or common name) of the active substance(s): Pharmaco-therapeutic group (ATC Code): Pharmaceutical form(s) and strength(s): Reference Number for the Decentralised Procedure Reference Member State: Member States concerned: Applicant (name and address) ADMINISTRATIVE INFORMATION ben-u-ron direkt Erdbeer/Vanille 250/500 mg Granulat in Beuteln ben-u-ron direkt Cappuccino 500/1000 mg Granulat in Beuteln Paracetamol Analgesic, Antipyretic, N02BE01 Granules, 250 mg / 500 mg/ 1000 mg/ DE/H/2690/ /DC DE Withdrawal: NL Losan Pharma GmbH Otto-Hahn-Str Neuenburg, Germany Names and addresses of manufacturers responsible for batch release in the EEA Losan Pharma GmbH Otto-Hahn-Str Neuenburg, Germany The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health. 3/6 Public AR

4 INTRODUCTION Based on the review of the data on quality, safety and efficacy, the application for ben-u-ron direkt Erdbeer/Vanille 250/500 mg Granulat in Beuteln / ben-u-ron direct Cappuccino 500/1000 mg Granulat in Beuteln is approved. 1. EXECUTIVE SUMMARY 1.1. Problem statement This report evaluates the chemical-pharmaceutical aspects of a decentralised application for Marketing Authorisation, using the hybrid application procedure as described in Article 10(3) of Directive 2001/83/EC. Essential similarity with Doliprane 500 mg comprim /tablets, Aventis Pharma Specialites, France is claimed. Doliprane is a medicinal product authorised on the basis of a complete dossier on (marketing authorisation number ). With Germany acting as RMS in this procedure, the applicant seeks marketing authorisations in NL. Based on major objections from CMS NL Losan Pharma GmbH requests the withdrawal of the marketing authorisation application for Paracetamol Gammaceta in the Netherlands About the product Paracetamol is a well known active substance with antipyretic properties (Ph. Eur. monograph). It is marketed in several dosage forms and strengths world wide since many years. The proposed medicinal product is a new developed oral pharmaceutical form. The usual oral adult dose of paracetamol is mg every 4 to 6 hours up to a maximum of 3 g daily. The maximum recommended daily dose is 4 g. Paracetamol should be taken with caution in patients with impaired liver and kidney function. Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. Paracetamol is metabolised mainly in the liver, producing several inactive metabolites, mainly by conjugation to glucuronic acid and sulphate. In adults, about 60 % of the drug undergoes glucuronidation and 35 % undergoes sulphation. Children have limited capacity for glucuronidation, and a large proportion of paracetamol is conjugated to sulphate (Kozer, Acta Paed 2006). Less than 5 % is excreted in urine as unchanged paracetamol. The elimination half-life varies from about 1-4 hours. Plasma protein binding is negligible at usual therapeutic concentrations General comments on compliance with GMP, GLP, GCP and agreed ethical principles. The RMS has been assured that acceptable standards of GMP are in place for these product types at all sites responsible for the manufacture and assembly of this product. For manufacturing sites within the Community, the RMS has accepted copies of current manufacturer authorisations issued by inspection services of the competent authorities as certification that acceptable standards of GMP are in place at those sites. The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health. 4/6 Public AR

5 2. SCIENTIFIC OVERVIEW AND DISCUSSION 2.1. Quality aspects Drug Substance The active substance paracetamol is described in the European Pharmacopoeia(Ph Eur). The quality of the drug substances is in compliance with the corresponding monograph of Ph Eur. The suitability of the monograph to test the drug substance has been verified by EDQM. A Certificate of Suitability has been granted by EDQM. The re-test period of five years is mentioned on the Certificate. Drug Product The manufacturer has developed granules for oral use which contain paracetamol in different strengths (250 mg/500 mg/1000 mg). The active granules are manufactured by coating of paracetamol in a fluid bed granulator, followed by a blending and screening step. All relevant quality characteristics of the active substance and the finished product (release and shelf-life) are specified. The proposed limits are accepted. The description of the analytical methods used to analyse the drug product are adequate, the validation results are plausible. A shelf life of 30 months for the vanilla-flavoured products with the 250 mg strength and 500 mg strength and 36 months for the cappuccino-flavoured product with the 500 mg strength and the 1000 mg strength respectively is accepted. The storage precaution Do not store above 30 C is necessary for the vanillaflavoured products Nonclinical aspects Pharmacodynamic, pharmacokinetic and toxicological properties of paracetamol are well known. As paracetamol is a widely used, well-known active substance, no further studies are required and the applicant provides none. Overview based on literature review is, thus, appropriate Clinical aspects The proposed medicinal product is a new developed oral pharmaceutical form. Therefore the submission of a bioequivalence study to a medicinal product with a Marketing Authorisation in a Member State or in the Community is necessary, according to the Note for guidance on the investigation of bioavailability and bioequivalence (CPMP/EWP/QWP/1401/98). To support the application, the applicant has submitted data of one pilot study and one pivotal three-period cross-over bioavailability study with the 1000mg pack sticks and Doliprane 500 mg comprim (Aventis, Fr) as reference product. In one study arm the 250mg pack sticks were administered to show doseproportionality. In the pilot study the pack sticks were administered with and without water to proof a potential change of resorption. The 500 mg strength is not included in the bioequivalence study, since the applicant intended the extrapolation of the results and conclusion of the bioequivalence study with the 1000 mg and 250 mg formulation because of: a. similar manufacturer and qualitative composition b. Dissolution profiles of Test and Reference product demonstrated linear kinetics of paracetamol Pharmacodynamics no new data Clinical efficacy / Clinical safety The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health. 5/6 Public AR

6 ben-u-ron direkt is indicated as follows: For symptomatic treatment of mild to moderate pain and fever. The application contains an adequate review of published clinical data. Regarding bioequivalence to the reference product clinical studies have been performed The applied indications and posology are agreed. Clinical safety no new data Pharmacovigilance system The applicant has provided documents that set out a detailed description of the system of pharmacovigilance (Version 5 dated 22 February 2010). A statement signed by the applicant and the qualified person for pharmacovigilance, indicating that the applicant has the services of a qualified person responsible for pharmacovigilance and the necessary means for the notification of any adverse reaction occurring either in the Community or in a third country has been provided. The Pharmacovigilance system fulfil the requirements as described in Volume 9A of the Rules Governing Medicinal Products in the European Union and provide adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country. 3. BENEFIT RISK ASSESSMENT The application contains an adequate review of published clinical data. The application is approved. The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health. 6/6 Public AR

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