Decentralised Procedure. Public Assessment Report. Lorazepam-neuraxpharm 1/ 2,5 mg Schmelztabletten. Lorazepam DE/H/4558/ /DC

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1 Decentralised Procedure Public Assessment Report Lorazepam-neuraxpharm 1/ 2,5 mg Schmelztabletten Lorazepam DE/H/4558/ /DC Applicant: neuraxpharm Arzneimittel GmbH, Germany 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... 5 III.1 Quality aspects... 5 III.2 Non-clinical aspects... 5 III.3 Clinical aspects... 5 IV. BENEFIT RISK ASSESSMENT... 8 Lorazepam-neuraxpharm, DE/H/4558/ /DC Public AR Page 2/8

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: Concerned Member States: Applicant (name and address) Lorazepam-neuraxpharm 1/ 2,5 mg Schmelztabletten Lorazepam N05BA06 Orodispersible tablet; 1 mg/ 2.5 mg DE/H/4558/ /DC DE MAA withdrawn in LU neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23, Langenfeld, Germany Lorazepam-neuraxpharm, DE/H/4558/ /DC Public AR Page 3/8

4 I. INTRODUCTION Based on the review of the data on quality, safety and efficacy, the application for Lorazepamneuraxpharm 1/ 2,5 mg Schmelztabletten, is approved. II. - in the symptomatic short-term relief of states of anxiety, tension and agitation as well as sleep disorders caused by such states and the relief of anxiety before diagnostic procedures and before and after surgical interventions EXECUTIVE SUMMARY II.1 Problem statement N/A II.2 About the product Lorazepam is an intermediate-acting member of the benzodiazepine class of drugs with high affinity for the GABAA receptor. This binding enhances the inhibitory effect of the neurotransmitter GABA, hence, resulting in anxiolytic, sedative and anticonvulsant properties. Lorazepam is indicated for the symptomatic short-term relief of states of anxiety, tension and agitation as well as sleep disorders caused by such states and the relief of anxiety before diagnostic procedures and before and after surgical interventions. II.3 General comments on the submitted dossier This decentralised application according to Art. 10(3) of Dir. 2001/83/EC as amended concerns a generic version of lorazepam, under the trade names Lorazepam-neuraxpharm 1/ 2,5 mg Schmelztabletten. The reference product is Tavor 1/ 2,5 mg Expidet by Pfizer Pharma GmbH, Germany, an oral lyphilisate of lorazepam registered since 12 th December 1986 in Germany. Hence, data protection has expired and generic products can be licensed. With Germany as the Reference Member State in this Decentralized Procedure, neuraxpharm Arzneimittel GmbH, Germany, originally applied for the Marketing Authorisations for Lorazepamneuraxpharm 1/ 2,5 mg Schmelztabletten in Luxemburg. However, the Applicant decided to withdraw the MAA in Luxemburg. 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. GMP active substance: Regarding the statement on GMP for the active substance a statement/declaration is provided from the manufacturer responsible for manufacture of the finished product and batch release situated in the EU. Lorazepam-neuraxpharm, DE/H/4558/ /DC Public AR Page 4/8

5 III. SCIENTIFIC OVERVIEW AND DISCUSSION III.1 Quality aspects Drug substance Lorazepam is described in the current Ph.Eur. A single source of Lorazepam is proposed. The manufacturer of the drug substance holds a valid Certificate of Suitability certifying that the quality of the drug substance is suitably controlled by the current version of the Ph. Eur. monograph of Lorazepam. In general the chemical-pharmaceutical documentation and Quality Overall Summary in relation to Lorazepam drug substance are of sufficient quality in view of the present European regulatory requirements. The control tests and specifications for drug substance are adequately drawn up. A re-test period of 5 years has been granted by the EDQM. Drug Product The development of the product has been described, the choice of excipients justified and their functions explained. The manufacturing process of the orodispersible tablets has been described. 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 of each tablet strength. The batch analysis results show that the finished products meet the specifications proposed. The description and choice of container closure system is in accordance with relevant EU-directives. The conditions used in the stability studies are according to the ICH stability guideline. A shelf-life of 36 months has been justified by stability results. The labelled storage condition Do not store above 30 C is required only for Lorazepam the 1 mg orodispersible tablets based on stability data provided. No special labelled storage conditions are necessary for Lorazepam 2.5 mg orodispersible tablets. III.2 Non-clinical aspects The pharmacological and toxicological properties of lorazepam are generally well known and have been summarised based on publicly available information in the Non-clinical Overview. On request of the RMS, Module 2.4 was complemented with a toxicological evaluation of the impurity profiles of drug substance and drug product, which confirms compliance with prevailing European guidelines (EMEA/CHMP/QWP/251344/2006; CPMP/ICH/2737/99; CPMP/ICH/2738/99; CPMP/ICH/283/95). In the course of this procedure, the instructions on use of the compound during pregnancy and lactation and the preclinical safety data contained in the proposed SmPC and PL, respectively, have been adequately amended in accordance with the reference product Tavor 1/ 2,5 mg Expidet. Environmental Risk Assessment (ERA) Since Lorazepam-neuraxpharm 1 / 2,5 mg Schmelztabletten are intended for generic substitution, this will not lead to an increased exposure to the environment. An environmental risk assessment is therefore not deemed necessary. III.3 Clinical aspects To support the application, the applicant has submitted as report one bioequivalence study (Study Code: LBS ): An open-label, randomized, single-dose, two-treatment, two-sequence, two period, two-way crossover bioequivalence study of lorazepam 2.5 mg oral dispersible tablets (Test) with Tavor 2.5 Expidet oral dispersible tablets containing lorazepam 2.5 mg of Pfizer Pharma GmbH, Linkstr. 10, 10785, Berlin (Reference) with a washout period of at least 07 days between each administration, in healthy, adult, male, human subjects under fasting condition. Lorazepam-neuraxpharm, DE/H/4558/ /DC Public AR Page 5/8

6 Pharmacokinetic parameters (non-transformed values; arithmetic mean ± SD) (n=37) Treatment AUC0-t AUC0- Cmax tmax xg/ml/h Test ± xg/ml/h ± xg/ml ± h ± Reference ± ± ± ± *Ratio (90% CI) AUC 0-t Area under the plasma concentration curve from administration to last observed concentration at time t. AUC 0-72h can be reported instead of AUC 0-t, in studies with sampling period of 72 h, and where the concentration at 72 h is quantifiable. Only for immediate release products AUC 0- Area under the plasma concentration curve extrapolated to infinite time. AUC 0- does not need to be reported when AUC 0-72h is reported instead of AUC 0-t C max Maximum plasma concentration Time until Cmax is reached t max *ln-transformed values Comparative Linear Plot of Average Lorazepam (ng/ml) Concentration vs Time: Conclusion: Considering the results of primary target parameters being within acceptance limits of %, it was concluded that the Test formulation, i.e. Lorazepam 2.5 mg oral dispersible tablets, is bioequivalent with the reference formulation i.e. Tavor 2.5 mg Expidet oral dispersible tablets containing 2.5 mg lorazepam, following single dose administration in fasting condition. Based on the submitted bioequivalence study Lorazepam 2.5 mg orodispersible tablets can be regarded as bioequivalent with Tavor 2.5 mg Expidet. The results of study LBS with the 2.5 mg formulation can be extrapolated to the other strength 1.0 mg, (according to conditions in Guideline on the Investigation of Bioequivalence CPMP/EWP/QWP/1401/98 Rev. 1/Corr*, section 4.1.6). Legal Status Subject to medical prescription, which may be renewed. User Testing The readability user testing of the PIL for Lorazepam-neuraxpharm was conducted between 10 July 2015 and 25 August 2015 in London. 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 Lorazepam-neuraxpharm, DE/H/4558/ /DC Public AR Page 6/8

7 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, 90 % being able to give the correct answer, to indicate that they understood the information presented. The general impression of the PL was mostly positive. In conclusion, the user test is acceptable. 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. Risk Management Plan The MAH has submitted a risk management plan, in accordance with the requirements of Directive 2001/83/EC as amended, describing the pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to Lorazepam. The MAH submitted a RMP for Lorazepam-neuraxpharm. The RMP includes the following summary of safety concerns: Summary of safety concerns Important identified risks Abuse/misuse Tolerance Dependence Overdose Drug interactions Drug withdrawal reactions Respiratory depression Important potential risks Missing information SJS/TEN Hepatitis Suicidal tendencies Use during pregnancy Use in obstetrics There are no additional risk minimisation measures and no additional pharmacovigilance activities. An updated RMP should be submitted: - At the request of the RMS; - Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time, but via different procedures. Lorazepam-neuraxpharm, DE/H/4558/ /DC Public AR Page 7/8

8 Periodic Safety Update Report (PSUR) With regard to PSUR submission, the MAH should take the following into account: PSURs shall be submitted in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. Marketing authorisation holders shall continuously check the European medicines web-portal for the DLP and frequency of submission of the next PSUR. For medicinal products authorized under the legal basis of Article 10(1) or Article 10a of Directive 2001/83/EC, no routine PSURs need to be submitted, unless otherwise specified in the EURD list. For medicinal products that do not fall within the categories waived of the obligation to submit routine PSURs by the revised pharmacovigilance legislation, the MAH should follow the DLP according to the EURD list. IV. BENEFIT RISK ASSESSMENT Marketing authorisation is recommended from a quality, clinical and non-clinical point of view. The application is approved. For intermediate amendments see current product information. Lorazepam-neuraxpharm, DE/H/4558/ /DC Public AR Page 8/8

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