Decentralised Procedure. Public Assessment Report. Pramipexol-ratiopharm 0,088/0,18/0,35/0,7 mg Tabletten. Pramipexole dihydrochloride monohydrate

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1 Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Pramipexol-ratiopharm 0,088/0,18/0,35/0,7 mg Tabletten Pramipexole dihydrochloride monohydrate DE/H/1258/ /DC Applicant: ratiopharm 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 CONTENTS I INTRODUCTION 4 II EXECUTIVE SUMMARY 4 II.1 ABOUT THE PRODUCT 4 II.2 GENERAL COMMENTS ON THE SUBMITTED DOSSIER 4 II.3 GENERAL COMMENTS ON COMPLIANCE WITH GMP, GLP, GCP AND AGREED ETHICAL PRINCIPLES. 4 II.4 QUALITY ASPECTS 5 II.5 NONCLINICAL ASPECTS 6 II.6 CLINICAL ASPECTS 6 III BENEFIT RISK ASSESSMENT 6 2/6 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) Names and addresses of manufacturers responsible for batch release in the EEA Pramipexol-ratiopharm 0,088 mg Tabletten Pramipexol-ratiopharm 0,18 mg Tabletten Pramipexol-ratiopharm 0,35 mg Tabletten Pramipexol-ratiopharm 0,7 mg Tabletten Pramipexole (as Pramipexole dihydrochloride monohydrate) N04BC05 Dopamine agonists tablets 0.088/0.18/0.35/0.7 mg DCP DE/H/1258/ /DC Germany (DE) AT, BE, CZ, DK, EE, ES, FI, FR, IT, LT, LU, LV, NL, NO, RO, SE, UK ratiopharm GmbH, Germany Graf-Arco-Straße 3 D Ulm Germany Merckle GmbH Ludwig-Merckle-Str. 3 D Blaubeuren Germany Hoechst-Biotike spol. s.r.o. Sklabinská 30, Martin Slovak Republik 3/6 Public AR

4 I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the application for Pramipexolratiopharm 0,088, 0,18, 0.,35, 0,7 mg Tabletten in the treatment of - the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or on off fluctuations). - symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of pramipexole (0.75 mg of salt) (see section 4.2). is approved. II EXECUTIVE SUMMARY II.1 About the product Pramipexole is a synthetic amino-benzothiazole derivative, a non-ergot dopamine agonist (DA). It has been shown to be a selective and specific full DA receptor agonist with high affinity and selectivity for the DA D2 receptor subfamily, and particularly the D3 receptor subtype. Pramipexol-ratiopharm 0.088/0.18/0.35/0.7 mg Tabletten are indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or on off fluctuations), and for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of pramipexole (0.75 mg of salt) (see section 4.2). II.2 General comments on the submitted dossier This decentralised application concerns a generic version of pramipexole, under different trade names. The originator product is Sifrol (0.088/0.18/0.35/0.7/1.1 mg, tablets) by Boehringer Ingelheim Int. GmbH, Germany, registered since With Germany as the Reference Member State in this Decentralised Procedure, ratiopharm GmbH is applying for the Marketing Authorisations for Pramipexole ratiopharm tablets in 17 CMS (AT, BE, CZ, DK, EE, ES, FI, FR, IT, LT, LU, LV, NL, NO, RO, SE, UK). II.3 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. 4/6 Public AR

5 II.4 Quality aspects Drug substance Module 3.2 S for Pramipexole dihydrochloride monohydrate is submitted as EDMFs. The active substance is manufactured in three main steps (subdivision by the assessor). The description is considered as sufficient. However control of intermediates is considered as defective. The proposed specifications for impurities in the active substance are in accordance with EU/ICH Q6A and Q3A guidelines. The analytical methods for assay, related substances and residual solvents used for the active substance is satisfactorily described and validated in accordance with the relevant EU/ICH guidelines on Analytical validation. Reference standards are insufficiently described. Confirmation that packaging materials comply with Ph. Eur. and directive 2002/72/EC is missing Pramipexole is a stable molecule. Stability studies according to the relevant EU/ICH stability guidelines have been submitted. Significant changes are not observed at ICH conditions (up to 66 months long term). Therefore the proposed retest period of 60 months is accepted. Drug product The immediate release tablets are formulated with well-known excipients. Validation data on production scale batches have been provided in the ARD The manufacturing process is conventional using standard techniques. However, the drug product has to be considered as non-standard due to its low active substance content. The initial stability batches showed severe stability problems therefore the process was optimised in regard to light protection and the limits for a loss of drying after granulation were tightened and a desiccant was added to primary container (HDPE bottle). The excipients maize starch, povidone, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate and purified water comply with the current version of the monograph in Ph.Eur. and are tested according to the analytical methods in Ph. Eur. The proposed limits on degradation products justified according to the EU/ICH Q3B guideline. The limits for dissolution are considered as not adequate. Other requirements are justified according to relevant EU/ICH guidelines and Ph.Eur. The analytical methods used for the drug product are described and validated in accordance with the relevant EU/ICH guidelines. However a number of minor issues have been raised. The description and choice of container closure system is in accordance with relevant directives. The stability studies have been carried out according to relevant EU/ICH stability guidelines. After process opimisation manufactured batches batches per strengths have been stored for up to 12 months at ICH conditions in a first stability study. However a new stability programm was started with batches produced according to the optimised manufacturing process. At least 18 month data are provided. In use stability tests show severe degradation. Although the stability results of new batches are well promising there are concerns regarding the validity of the results. Therefore an appropriate commitment was given by the applicant. Due to available stability results the application on use multidose containers was withdrawn. Against this background the extrapolation of the length of shelf life of this product line is not acceptable and the length of shelf life for the 0.18, 0.35 and 0.7 mg strengths should be limited to 12 months. 5/6 Public AR

6 For the blisters of the mg strength a shelf life of 18 month is acceptable if stored below 25 C. After fulfilment of the commitment the length of shelf life can be reassessed. II.5 Nonclinical aspects Pharmacodynamic, pharmacokinetic and toxicological properties of pramipexole are well known. As pramipexole 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. The non-clinical overview on the pre-clinical pharmacology, pharmacokinetics and toxicology is adequate. II.6 Clinical aspects In order to demonstrate bioequivalence between the Applicant s formulation and the brand leader a study of the Pramipexole 0.18 mg tablet was conducted. The reference product was Sifrol 0.18 mg tablet manufactured by Boehringer Ingelheim GmbH & Co. KG, Germany. The results of this study can be extrapolated to the other dose strengths if all conditions defined in the EMEA Note for Guidance on the Investigation of Bioavailability and Bioequivalence are fulfilled. The bioequivalence study is stated to be compliant with the relevant guidelines for GCP. Approval is recommended from the clinical point of view. Description of Pharmacovigilance System The Pharmacovigilance system as described by the applicant fulfils the requirements 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. III BENEFIT RISK ASSESSMENT The application contains an adequate review of published clinical data and the bioequivalence has been shown. The application is approved. 6/6 Public AR

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