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Public Assessment Report Scientific discussion

Fexofenadin Cipla (fexofenadine hydrochloride)

SE/H/1163/01-02/DC

INTRODUCTION

The application for Fexofenadin Cipla, 120 mg, 180 mg, film-coated tablet, is a generic application made according to Article 10(1) of Directive 2001/83/EC. The applicant, Cipla Europe NV, applies through the Decentralised Procedure with Sweden acting as reference member state (RMS) and DE, DK, ES, FI, FR, HR, HU, IT, NO, PL, PT and SI as concerned member states (CMS).

The reference medicinal product chosen for the purposes of establishing the expiry of the data protection period is Allegra, 120 mg, film-coated tablet and Telfast, 180 mg, film-coated tablet authorised in SE since 1997, with Sanofi-aventis AB as marketing authorisation holder.

The reference product used in the bioequivalence study is Telfast, 180 mg, film-coated tablet from UK with Sanofi-aventis as marketing authorisation holder.

For approved indications, see the Summary of Product Characteristics.

II.    QUALITY ASPECTS

11.1    Introduction

Fexofeandin Cipla is presented in the form of film-coated tablets containing 120 mg or 180 mg of fexofenadine hydrochloride. The excipients of the tablet cores are microcrystalline cellulose, maize starch, croscarmellose sodium, povidone and magnesium stearate of vegetable origin. Further, the film-coating excipients are hypromellose, titanium dioxide (E171), macrogol and iron oxide yellow (E172). In addition, the film-coat of the 120 mg tablets does also contain iron oxide red (E172). The tablets are packed in PVC/PVdC/Aluminium blister packages.

11.2    Drug Substance

The drug substance fexofenadine hydrochloride has a monograph in the European Pharmacopoeia (Ph. Eur.). Fexofenadine hydrochloride is described as a white or almost white powder that is slightly soluble in water. It has one asymmetric carbon atom but is manufactured as a racemic mixture.

The structure of fexofenadine hydrochloride has been adequately proven and its physicochemical properties sufficiently described. Relevant information on polymorphism is presented. The route of synthesis has been adequately described and satisfactory specifications have been provided for starting materials, reagents and solvents.

The active substance specification includes relevant tests and the limits for impurities/degradation products have been justified. The analytical methods applied are suitably described and validated.

Stability studies under ICH conditions have been conducted and the data provided are sufficient to confirm the retest period.

11.3    Medicinal Product

Fexofenadin Cipla 120 mg and 180 mg film-coated tablets are formulated using excipients described in the current Ph. Eur., except for iron oxide red and iron oxide yellow which

comply with USP/NF. None of the raw materials used in the product are of human or animal origin. The excipients have been declared by the respective supplier to be without risk of TSE/BSE contamination.

The product development has taken into consideration the physico-chemical characteristics of the active substance.

The manufacturing process has been sufficiently described and critical steps identified. Results from the process validation studies confirm that the process is under control and ensure both batch to batch reproducibility and compliance with the product specification.

The tests and limits in the specification are considered appropriate to control the quality of the finished product in relation to its intended purpose.

Stability studies under ICH conditions have been performed and the data presented support the shelf life as stated in the SPC with no special storage precautions.

III. NON-CLINICAL ASPECTS

III.1 Discussion on the non-clinical aspects

Since this product has been shown to be essentially similar and refer to a product approved based on a full application with regard to preclinical data, no further such data have been submitted or are considered necessary.

IV.    CLINICAL ASPECTS

IV.1    Pharmacokinetics

Bioequivalence was evaluated in one randomised, two-treatment, four-period, two-sequence single-dose crossover replicate study conducted in 48 healthy volunteers, comparing Fexofenadin Cipla, 180 mg, film-coated tablet with Telfast, 180 mg, film-coated tablet under fasting conditions. The study was conducted at PEE-DEE Infotech, Mahape, Navi Mumbai, India between 06 May and 16 July 2013. Blood samples were collected pre-dose and up to 72 hours post-dose. The study design is considered acceptable. Plasma concentrations of fexofenadine were determined with an adequately validated LC/MS/MS method. For AUC_0-t and C_max the 90% confidence interval for the ratio of the test and reference products fell within the conventional acceptance range of 80.00-125.00%. From a pharmacokinetic point of view, absence of studies with the additional strength(s) is acceptable, as the pharmacokinetics of fexofenadine is practically linear at doses between 40 mg and 240 mg.

Based on the submitted bioequivalence study, Fexofenadin Cipla is considered bioequivalent with Telfast.

IV.2 Discussion on the clinical aspects

Since this product has been shown to be essentially similar and refer to a product approved based on a full application with regard to clinical efficacy/safety data, no further such data have been submitted or are considered necessary.

OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION

User consultation

Fexofenadin Cipla 180 mg film-coated tablet:

The package leaflet has been evaluated via a user consultation study in accordance with the requirements of Articles 59(3) and 61(1) of Directive 2001/83/EC. The language used for the purpose of user testing the PIL was English.

The results show that the package leaflet meets the criteria for readability as set out in the Guideline on the readability of the label and package leaflet of medicinal products for human use.

Fexofenadin Cipla 120 mg film-coated tablet:

A user consultation with target patient groups on the package information leaflet (PIL) has been performed on the basis of a bridging report making reference to Fexofenadin Cipla 180 mg film-coated tablet: SE/H/1163/02/DC. The bridging report submitted by the applicant has been found acceptable.

The results of the conducted bioequivalence study can be extrapolated to other strengths since the criteria for biowaiver for additional strengths are fulfilled according to the Note for Guidance on the Investigation of Bioavailability and Bioequivalence.

The risk/benefit ratio is considered positive and Fexofenadin Cipla, 120 mg, 180 mg, film-coated tablet is recommended for approval.

VI. APPROVAL

The Decentralised procedure for Fexofenadin Cipla, 120 mg, 180 mg, film-coated tablet was successfully finalised on 2014-10-13.

Public Assessment Report - Update

Scope	Procedure number	Product Information affected	Date of start of the procedure	Date of end of procedure	Approval/ non approval	Assessment report attached
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