Decentralised Procedure. Public Assessment Report. Paracetamol-ratiopharm 10 mg/ml Infusionslösung Paracetamol DE/H/1908/001/DC

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1 Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Paracetamol-ratiopharm 10 mg/ml Infusionslösung Paracetamol DE/H/1908/001/DC Applicant: TEVA Pharma B.V., The Netherlands Reference Member State DE The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health. 1/7 Public AR

2 TABLE OF CONTENTS I. INTRODUCTION... 4 II. EXECUTIVE SUMMARY... 4 II.1 Problem statement... 4 II.2 About the product... 4 II.3 General comments on the submitted dossier... 4 II.4 General comments on compliance with GMP, GLP, GCP and agreed ethical principles.. 5 III. SCIENTIFIC OVERVIEW AND DISCUSSION... 5 III.1 Quality aspects... 5 III.2 Nonclinical aspects... 6 III.3 Clinical aspects... 6 IV. BENEFIT RISK ASSESSMENT /7 Public AR

3 ADMINISTRATIVE INFORMATION 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) Paracetamol-ratiopharm 10 mg/ml Infusionslösung Paracetamol N02BE01 Solution for Infusion DE/H/1908/001/DC DE BE, BG, CZ, DK, EL, ES, FI, HU, IE, LU, NL, NO, PL, RO, SE FR withdrawn TEVA Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, The Netherlands 3/7 Public AR

4 I. INTRODUCTION Based on the review of the data on quality, safety and efficacy, the application for Paracetamolratiopharm 10 mg/ml Infusionslösung in the treatment of Short-term treatment of moderate pain, especially following surgery and for the short-term treatment of fever, when administration by intravenous route is clinically justified by an urgent need to treat pain or hyperthermia and/or when other routes of administration are not possible is approved. II. EXECUTIVE SUMMARY II.1 Problem statement The applicant is aiming for registration of paracetamol solution for infusion containing 10 mg/ml Paracetamol. Paracetamol is a well established analgesic and antipyretic agent. Its use is indicated for the symptomatic relief of fever and of mild to moderate pain. The market leader product is PERFALGAN 10 mg/ml that is marketed by Bristol-Myers Squibb Pharmaceuticals Ltd in several Member States. II.2 About the product Paracetamol is a well-known analgesic with antipyretic properties. The usual oral adult dose is mg every 4 to 6 hours up to a maximum of 3 g daily. The maximal recommended daily dose is 4 g. Paracetamol should be taken with caution in patients with impaired liver and kidney function. 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 sulfation. Children have limited capacity for glucuronidation, and a large proportion of paracetamol is conjugated to sulfate (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. Paracetamol solution for injection is indicated in the short-term treatment of moderate pain, particularly post-surgery pain, and in the short-term treatment of fever, when the intravenous route is clinically justified by the urgent need to treat pain or hyperthermia and/or when other routes of administration cannot be used. II.3 General comments on the submitted dossier This is a decentralised application for a solution for infusion containing 10 mg / ml of Paracetamol. With Germany acting as the reference member state, the applicant also seeks marketing authorisations in BE, BG, CZ, DK, EL, ES, FI, HU, IE, LU, NL, NO, PL, RO and SE. However, the applicant decided to withdraw the application in FR. This abridged application has been submitted under article 10.1(a) of Directive 2001/83/EC, so called generic application referring as essential similar to the originator product Perfalgan 10 mg / ml solution from Bristol-Myers Squibb. Perfalgan has been authorized through a Mutual Recognition Procedure (FR/H/0197/001) with France being acting as RMS and different European countries in /7 Public AR

5 II.4 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. For manufacturing sites outside the Community, the RMS has accepted copies of current GMP Certificates of satisfactory inspection summary reports, close-out letters or exchange of information issued by the inspection services of the competent authorities (or those countries with which the EEA has a Mutual Recognition Agreement for their own territories) as certification that acceptable standards of GMP are in place at those non-community sites. III. III.1 SCIENTIFIC OVERVIEW AND DISCUSSION Quality aspects Drug substance The active substance paracetamol is described in the European Pharmacopoeia (EP). The quality of the drug substance paracetamol is controlled in compliance with the corresponding monograph of the EP. The suitability of the monograph to test the drug substance has been verified by CEP. The results indicated that paracetamol is stable for five years when the active substance is stored in LDPE bags. The re-test period is five years. Drug Product The finished product containing paracetamol in a concentration of 10 mg/ml is manufactured by Teva Pharmaceutical Works, Gödöllő (Hungary). The product is a sterile solution for infusion filled into a plastic infusion bag consisting of a multilayer Polyolefin/Styrene-Ethylene-Butylene block copolymer with one or two single function polypropylene connection ports. The bag is closed with a synthetic isoprene rubber stopper and polypropylene cap. Secondary packaging is an aluminium overpouch (with clear window) or a transparent plastic overpouch plus cardboard box. The excipients used in the product are conventional pharmaceutical ingredients. The function of each ingredient included in the product has been described. The manufacturing process including filtration and terminal sterilisation of the product packed in the overpouch has been described in detail. The finished product specifications (for release and shelf life) comply with general pharmacopeial requirements. The batch results confirm the specification. The shelf life is 24 months with the following storage declaration: Store below 30 C. Do not refrigerate or freeze. Results of the on-going stability studies have been provided. Photostability data are provided confirming that the product should be protected from light by secondary packaging. 5/7 Public AR

6 III.2 Nonclinical aspects The nonclinical overview has been written by Andrea Gresznaryk, MD with specialisation in psychiatry. The report refers 31 publications up to year 2010 and is dated October 07, There are no issues concerning the qualitative composition of the current product that contains the following excipients; sodium acetate trihydrate, sodium citrate, sodium metabisulphite (E223), mannitol (E421), acetic acid glacial (for ph adjustment), water for injections. The specification limits for the impurities/extractables are in accordance with the relevant guidelines. SmPC and PL are essentially in line with those of the reference product and are accepted. From a non-clinical point of view, there are no objections to marketing authorisation of Paracetamol 10 mg/ml Infusionslösung. III.3 Clinical aspects Pharmacokinetics The submission of a bioequivalence study is not required since the test product is to be administered as an aqueous intravenous solution containing the same active substance as the currently approved product (please refer to chapter of the Note for guidance on the investigation of bioavailability and bioequivalence (CPMP/EWP/QWP/1401/98/Rev.1, January 2010)). Pharmacodynamics The precise mechanism of the analgesic and antipyretic properties of paracetamol has not yet established; it may involve central and peripheral actions. Paracetamol solution for infusion provides onset of pain relief within 5 to 10 minutes after the start of administration. The peak analgesic effect is obtained in 1 hour and the duration of this effect is usually 4 to 6 hours. Paracetamol solution for infusion reduces fever within 30 minutes after the start of administration with a antipyretic effect duration of at least 6 hours. Clinical efficacy/clinical safety The provided clinical overview on the clinical pharmacology, efficacy and safety is adequate. Assessment of User Testing Overall, the test methodology follows the guidelines of the European Commission (Guideline on the readability of the label and package leaflet of medicinal products for human use, Revision January 2009; Update of Directive 2001/83/EC as amended by Directive 2004/27/EC / Guidance concerning consultations with target patient groups for the packet leaflet, May 2006). Both the first and the second test round met the success criteria of more than 90% of the subjects being able to locate the requested information, and of those, more than 90% being able to give the correct answer, to indicate that they understood the information presented. The readability test is acceptable. Description of Pharmacovigilance System The applicant has provided documents that set out a detailed description of the TEVA Pharmacovigilance System (Version 9 dated June 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. 6/7 Public AR

7 The Pharmacovigilance system as described by the applicant fulfils the requirements as described in Volume 9A of the Rules Governing Medicinal Products in the European Union and provides 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. Risk Management Plan The MAH has submitted a Risk Management Plan. The requested risks, pharmacovigilance activities and risk minimisation activities were taken into account accordingly. IV. BENEFIT RISK ASSESSMENT The application contains an adequate review of published clinical data. The submission of a bioequivalence study is not required since the test product is to be administered as an aqueous intravenous solution containing the same active substance as the currently approved product (please refer to chapter of the Note for guidance on the investigation of bioavailability and bioequivalence (CPMP/EWP/QWP/1401/98/Rev.1, January 2010)). The application is approved. For intermediate amendments see current product information. 7/7 Public AR

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