Decentralised Procedure. Public Assessment Report
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1 Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Rocuronium Tamarang 10 mg/ml Injektionslösung/Infusionslösung Rocuronium bromide DE/H/1785/001/DC Applicant: Tamarang, S.A. Reference Member State DE The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health. 1/5 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..4 III. SCIENTIFIC OVERVIEW AND DISCUSSION... 4 III.1 Quality aspects... 4 III.2 Nonclinical aspects... 5 III.3 Clinical aspects... 5 IV. BENEFIT RISK ASSESSMENT /5 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 Rocuronium Tamarang 10 mg/ml Injektionslösung/Infusionslösung Rocuronium bromide M03AC09 Solution for injection 10 mg/ml DE/H/1785/001/DC DE BE, AT, PL, ES, PT Tamarang, S.A. Balmes, 84, 4 2a E BARCELONA Solupharm Pharmazeutische Erzeugnisse GmbH Industriestr. 3 D Melsungen 3/5 Public AR
4 I. INTRODUCTION Based on the review of the data and the Applicant s response to the questions raised by RMS and CMS on quality, safety and efficacy, the application for Rocuronium Tamarang 10 mg/ml Injektionslösung/Infusionslösung, in the treatment of Rocuronium Tamarang an adjunct to general anaesthesia to facilitate tracheal intubation during routine and rapid sequence induction, to provide skeletal muscle relaxation during surgery, and as an adjunct in the intensive care unit (ICU) (e.g. to facilitate intubation), for short term use is approved. II. EXECUTIVE SUMMARY II.1 Problem statement For generic application this section is not applicable. II.2 About the product Rocuronium bromide is an aminosteroid neuromuscular blocking drug of intermediate duration which is structurally related to vecuronium. Rocuronium is used to facilitate tracheal intubation and to provide muscle relaxation during surgery. The onset of neuromuscular block is more rapid than with other nondepolarizing relaxants currently in use, therefore it is used also for rapid sequence induction. II.3 General comments on the submitted dossier The current application is submitted under Article 10(1) of the Directive 2001/83/EC. The reference product of the marketing authorisation holder Organon is marketed under the tradename Esmeron throughout the EU. The active substance of the reference product is rocuronium bromide. The product, for which essentially similarity is claimed, does contain the same qualitative and quantitative composition in terms of active substance: 10 mg/ml rocuronium bromide. A clinical overview discussing pharmacology, efficacy and safety with several literature references was submitted. This is acceptable as the product is well-known and extensively used in clinical practice. 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. III. SCIENTIFIC OVERVIEW AND DISCUSSION III.1 Quality aspects Drug substance Rocuronium bromide is supplied by Farmhispania.The quality of the drug substance rocuronium bromide is controlled in compliance with the monograph of the European Pharmacopoiea (Ph.Eur.). The suitability of the monograph to test the drug substance has been verified by EDQM. A CEP has been provided. The re-test period of 2 years when stored in a freezer with double polyethylene film bags as container closure system is acceptable. 4/5 Public AR
5 Drug Product The goal of the project was to develop a 1:1 copy with the innovator product Rocuronium bromide Injection/Infusion. The chemical quality of Esmeron and Rocuronium bromide 10 mg/ml solution for injection/infusion has been compared regarding viscosity, surface tension, specific gravity, relative density, density, osmolarity, buffering capacity. Both products are comparable. The drug product is a solution for injection/infusion. All excipients comply with the Ph. Eur. The manufacturing process has been described in detail, validation data of the sterilisation procedure has been provided. The major concern which arose during assessment of the documentation and all further questions which were considered other concerns are resolved. A shelf life of 2 years is accepted. III.2 Nonclinical aspects Pharmacodynamic, pharmacokinetic and toxicological properties of rocuronium are well known. As rocuronium is a widely used, well-known active substance, no further studies are required and the applicant provides none. III.3 Clinical aspects The clinical overview on the clinical pharmacology, efficacy and safety is adequate. According the EMEA Note for Guidane on the investigation of bioavailability and bioequivalence, no bioequivalence studies are required for aqueous oral solutions, provided that the concentration of the active substance is similar as the reference product. This is fulfilled. The excipients are similar to the reference product. Pharmacovigilance system Details have been provided of the Tamarang S.A. pharmacovigilance system (Version 02 dated 14 August 2009). 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 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. IV. BENEFIT RISK ASSESSMENT The application contains a review of published clinical and nonclinical data. The application is approved. 5/5 Public AR
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