Decentralised Procedure. Public Assessment Report

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1 Doc. Ref: CMDh/208/2005 Rev.5 December 2013 Decentralised Procedure Public Assessment Report Paracetamol Bristol-Myers Squibb 250 / 500 mg mit Erdbeer-/Vanillegeschmack Granulat in Beuteln ; 500 / 1000 mg Capuccinogeschmack Granulat in Beuteln Paracetamol DE/H/3925/ /DC Applicant: Bristol-Myers Squibb S.A.R.L., France Reference Member State DE

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.4 III. SCIENTIFIC OVERVIEW AND DISCUSSION... 4 III.1 Quality aspects... 4 III.2 Non-clinical aspects... 5 III.3 Clinical aspects... 5 IV. BENEFIT RISK ASSESSMENT... 7 Paracetamol Bristol-Myers Squibb, DE/H/3925/ /DC Public AR Page 2/7

3 ADMINISTRATIVE INFORMATION Proposed name of the medicinal product(s) in the RMS Name of the drug substance (INN name): Pharmaco-therapeutic group (ATC Code): Pharmaceutical form(s) and strength(s): Reference Number(s) for the Decentralised Procedure Reference Member State: Member States concerned: Applicant (name and address) Paracetamol Bristol-Myers Squibb 250 / 500 mg Erdbeer-/Vanillegeschmack Granulat in Beuteln ; 500 / 1000 mg Capuccinogeschmack Granulat in Beuteln Paracetamol N02BE01 Granules 250mg, 500 mg, 1000 mg DE/H/3925/ /DC DE BE, FR, LU Bristol Myers Squibb S.A.R.L. 3 rue Joseph Monier, F Rueil-Malmaison, France Paracetamol Bristol-Myers Squibb, DE/H/3925/ /DC Public AR Page 3/7

4 I. INTRODUCTION Based on the review of the data on quality, safety and efficacy, the application for Paracetamol Bristol-Myers Squibb 250 / 500 mg Erdbeer-/Vanillegeschmack Granulat in Beuteln ; 500 / 1000 mg Capuccinogeschmack Granulat in Beuteln, in the indication Symptomatic treatment of mild to moderate pain and/or fever, is approved. II. EXECUTIVE SUMMARY II.1 Problem statement II.2 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 to 60 minutes after ingestion. Paracetamol is metabolised mainly in the liver, producing several inactive metabolites, mainly by conjugation to glucuronic acid and sulphate. In adults, 60 to 80 % of the drug undergoes glucuronidation and 20 to 30 % 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. II.3 General comments on the submitted dossier This report evaluates the chemical-pharmaceutical aspects of a decentralised application for Marketing Authorisation, using a hybrid application procedure as described in Article 10(3) of Directive 2001/83/EC, as amended. Reference is made to Doliprane 500 mg comprimé /tablets, Aventis Pharma Specialites, France. 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 applies for a marketing authorisation in BE, FR and LU. 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. The applicant confirms that the BE studies provided has been conducted in accordance with the standards of GCP. III. SCIENTIFIC OVERVIEW AND DISCUSSION III.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 (R1-CEP Rev 03). The retest period of the substance is 60 months if stored in a polyethylene bag placed in a fibre or tin drum. Moreover it is mentioned that the holder of the certificate has declared the absence of use of material of human or animal origin in the manufacture of the substance. Paracetamol Bristol-Myers Squibb, DE/H/3925/ /DC Public AR Page 4/7

5 Drug Product Granules for oral use were developed 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. The manufacturing process has been validated at full-scale batches. 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. Satisfactory batch analyses have been presented. The batch analyses data together with the results obtained from the validation and stability testing confirm consistency and uniformity of the product based on the parameters tested and indicate the reproducibility of the manufacturing process for the drug product. The suitability of the reference standards has been shown. The applied primary packaging systems, single foil aluminium stick packs, are standard for this formulation. The provided specifications and information for the proposed container closure systems are considered as sufficient. Data of stability testing in accordance with ICH requirements at long-term, intermediate and accelerated conditions have been provided for six pilot scale batches and four full-scale of the final products packed in the different stick/ packaging materials. Results up to a storage time of 6 months at accelerated, 12 months under intermediate conditions and 36/24 months at long-term conditions have been provided. With exception of discolouration of the strawberry formulation in pilot batches under accelerated conditions, no significant change of the drug products tested could be observed. The drug products applied are stable. Results of photostability testing have been presented. The results show the stability of the AS in the DP and would justify that no special conditions for storage is necessarily. A shelf life of 36 months under the storage requirements: Keep the container in the outer carton in order to protect from light and from moisture, (only for 250 and 500 mg drug products: Do not store above 30 C) is accepted. III.2 Non-clinical aspects Pharmacology, Pharmacokinetics, Toxicology Pharmacodynamic, pharmacokinetic and toxicological properties of paracetamol are well known. As paracetamol is a widely used, well-known active substance, the applicant has not provided additional non-clinical studies and further non-clinical studies are not required. Overview based on literature review is, thus, appropriate. The submitted non-clinical overview on the non-clinical pharmacology, pharmacokinetics and toxicology of paracetamol is considered adequate. Environmental Risk Assessment (ERA) The applicant has presented data for all concerned member states which indicate that there is no increase in exposure of the environment to paracetamol. III.3 Clinical aspects Pharmacokinetics 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 (PAR(LOS)-BQA- Losan-2006) and one pivotal three-period cross-over bioavailability study (SC02707-Losan-2008) with the 1000mg pack sticks and Doliprane 500 mg comprimé (Aventis, FR) as reference product. In one study arm the 250mg pack sticks were administered to show dose-proportionality. 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 pivotal BE study, since the applicant intended the extrapolation of the results and conclusion of the bioequivalence study with the 1000 mg and 250 mg formulation based on a bracketing approach. Paracetamol Bristol-Myers Squibb, DE/H/3925/ /DC Public AR Page 5/7

6 The study program has been accepted within procedures DE/H/ / and DE/H/ / /DC by the RMS and several CMSs (AT, BE, BG, DK, FI, IE, IT, LT, LU, MT, NO, PL and SE). Pharmacodynamics Clinical efficacy Clinical safety User Testing The MAH submitted a Readability Testing for Losan Stick Packs 500 mg (in this assessment called as Paracetamol 500), which is deemed acceptable. The final report of the readability user test of the leaflet is dated on Additionaly an acceptable bridging report for the other dosage strength has been submitted. User Test Methodology and results: A full user testing was performed on the PL of Paracetamol Losan 500 mg granules in English. The participants were considered to be representative of the target population. 10 Males and 10 females over the age of years were eligible for participation in this user test, according to inclusion/exclusion criteria well detailed in the report and acceptable participants characteristics were provided in section of the report. Recruitment is acceptable in terms of age and gender. The procedure was divided into 2 rounds of interview including 10 participants each, and a pilot round including 3 participants. A list of 15 specific and general questions was asked using a specimen of the leaflet. The duration for reading the PL ranged between 9 and 19 minutes. The duration of each interview was not longer than 30 minutes (20`-28 ) The aim of the test is to assess whether respondents are able to: - locate information - understand it. The success criteria were answers / usability. traceability and comprehensibility. The evaluation was defined as follows: 1 and 2 means fulfil the success criteria and 3 and 4 doesn`t fulfil. The target was to fulfil 90% in minimum. During the pilot round of testing the questionnaire was checked by 3 volunteers. Following round 1 and 2 of the main stage all questions meet the success criteria : All questions achieved the benchmark in correct answers. Therefore it was considered that improvement is not necessary. Design & Layout: The overall layout and point size of the leaflet was deemed acceptable. None of the participants were negative about any aspect of the layout. Therefore the layout of the leaflet remained unchanged. Summary Pharmacovigilance system The Applicant/Proposed Future MAH has submitted a signed Summary of the Applicant's/Proposed Future MAH's Pharmacovigilance System. Provided that the Pharmacovigilance System Master File fully complies with the new legal requirements as set out in the Commission Implementing Regulation and as detailed in the GVP module, the RMS considers the Summary acceptable. Paracetamol Bristol-Myers Squibb, DE/H/3925/ /DC Public AR Page 6/7

7 Risk Management Plan Summary of Safety Concerns Important identified risks: Hepatobiliary Disorders, Abnormal Liver Function, Drug Interaction with Anticoagulants, Drug Interaction with Enzyme Inducers and Hypersensitivity. Important potential risks: Not applicable Important missing information: Neonates and premature neonates Pregnant and lactating women Other safety concerns: Risk of non-intentional overdose by confusion between (mg) and (ml) Concerning the possibility of unintentional overdose through confusion between milligrams and milliliters with regard to the injectable formulation of paracetamol, additional risk minimization measures have included an explanatory letter to health care professionals and a poster for nurses. Periodic Safety Update Report (PSUR) PSURs should be submitted based on the requirements of the EURD list. IV. BENEFIT RISK ASSESSMENT The application contains an adequate review of published clinical data. The results of the comparison between Paracetamol Bristol-Myers Squibb 1000 mg Granulat in Beuteln and Doliprane 2 x 500mg tablets show that bioequivalence is proven between test and reference formulations. Dose proportionality of the 1000 mg and the 250 mg strengths was demonstrated; furthermore, following adjustment for dose, bioequivalence is proven between Paracetamol Bristol-Myers Squibb 250 mg Granulat in Beuteln and Doliprane 2 x 500mg tablets. Applying a bracketing approach it can be concluded that the Paracetamol Bristol-Myers Squibb 500 mg Strawberry / Capuccino Granulat in Beuteln will exhibit similar behavior to that of the 250 mg and 1000 mg strengths. The application is approved. For intermediate amendments see current product information. Paracetamol Bristol-Myers Squibb, DE/H/3925/ /DC Public AR Page 7/7

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