Public Assessment Report. Decentralised Procedure. Cefadroxil 250 mg/5 ml granules for oral. (Cefadroxil monohydrate)

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1 Public Assessment Report Decentralised Procedure Cefadroxil 250 mg/5 ml granules for oral suspension (Cefadroxil monohydrate) UK licence no: PL 34088/0033 Alkaloid-INT d.o.o. 1

2 Cefadroxil 250 mg/5 ml granules for oral suspension PL 34088/0033 LAY SUMMARY On 9 th August 2013, the Medicines and Healthcare products Regulatory Agency (MHRA) granted a Marketing Authorisation to Alkaloid-INT d.o.o. for the medicinal product Cefadroxil 250 mg/5 ml granules for oral suspension (PL 34088/0033; ). This medicine is only available on prescription from the doctor. Cefadroxil is an antibiotic. It belongs to a group of antibiotics called cephalosporins. These antibiotics are similar to penicillin. Cefadroxil kills bacteria and can be used against various types of infections. Like all antibiotics, cefadroxil is only effective against certain types of bacteria. It is therefore appropriate to treat certain types of infections. Cefadroxil can be used to treat: - infections of the throat; - uncomplicated infections of the bladder and kidneys; - uncomplicated infections of the skin and soft tissue. No new or unexpected safety concerns arose from this application and it was, therefore, judged that the benefits of taking Cefadroxil 250 mg/5 ml granules for oral suspension outweigh the risks; hence a Marketing Authorisation was granted. 2

3 TABLE OF CONTENTS Module 1: Information about initial procedure Page 4 Module 2: Summary of Product Characteristics Page 5 Module 3: Patient Information Leaflet Page 6 Module 4: Labelling Page 7 Module 5: Scientific Discussion Page 8 I. Introduction II. About the Product III. Scientific Overview and Discussion III.1. Quality aspects III.2. Non-clinical aspects III.3. Clinical aspects IV. Overall conclusion and Benefit-Risk Assessment Module 6 Steps taken after initial procedure Page 15 3

4 Module 1 Information about initial procedure Product Name Type of Application Active Substance Form Strength MA Holder RMS CMSs Procedure Number Cefadroxil 250 mg/5 ml granules for oral suspension Article 10(1), Generic application Cefadroxil monohydrate Granules for Oral Suspension 250 mg/5 ml Alkaloid-INT d.o.o. Šlandrova ulica 4, 1231 Ljubljana - Črnuče Slovenia UK Austria, Bulgaria, Czech Republic, France, Germany, Poland, Romania, Slovak Republic and Slovenia Timetable Day 210: 1 st August

5 Module 2 Summary of Product Characteristics In accordance with Directive 2010/84/EU the Summaries of Product Characteristics (SmPC) for products that are granted Marketing Authorisations at a national level are available on the MHRA website. 5

6 Module 3 Patient Information Leaflet In accordance with Directive 2010/84/EU the Patient Information Leaflets (PIL) for products that are granted Marketing Authorisations at a national level are available on the MHRA website. 6

7 Module 4 Labelling 7

8 Module 5 Scientific discussion during initial procedure I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the Reference Member State (RMS) and Concerned Member States (CMSs) consider that the application for Cefadroxil 250 mg/5 ml granules for oral suspension could be approved for the following indications. - Streptococcal pharyngitis and tonsillitis - Uncomplicated urinary tract infections - Uncomplicated skin and soft tissue infections This application was submitted according to Article 10(1) of 2001/83/EC, as amended. The reference medicinal product for this application is Baxan 250 mg/5 ml suspension (PL 00125/0111), which was first authorised to Bristol Myers Squibb Pharmaceuticals Ltd. on 11 th December The reference product has been authorised in the European community for more than 10 years, so the period of data exclusivity has expired. With UK as the RMS in this Decentralised Procedure (), Alkaloid-INT d.o.o. applied for the Marketing Authorisation for Cefadroxil 250 mg/5 ml granules for oral suspension in the following CMSs. : Austria, Bulgaria, Czech Republic, France, Germany, Poland, Romania, Slovak Republic and Slovenia. Cefadroxil is a cephalosporin for oral administration which inhibits bacterial wall synthesis of actively dividing cells by binding to one or more penicillin-binding proteins. The result is formation of a defective cell wall that is osmotically unstable, and bacterial cell lysis. No new clinical or non-clinical studies were conducted, which is acceptable given that this is a generic application, which refers to an originator product that has been licensed for over 10 years. A bioequivalence study was carried out in accordance with Good Clinical Practice (GCP). The RMS has been assured that acceptable standards of GMP are in place for this product type 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. The RMS considers that 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. A suitable justification for non-submission of the risk management plan has been submitted. This is satisfactory. All member states agreed to grant a licence for the above product at the end of the procedure (Day st August 2013). After a subsequent national phase, the UK granted a licence for this product on 9 th August 2013 (PL 34088/0033). 8

9 II. ABOUT THE PRODUCT Name of the product in the Reference Member State Name(s) of the active substance(s) (USAN) Pharmacotherapeutic classification (ATC code) Pharmaceutical form and strength(s) Reference numbers for the Decentralised Procedure Reference Member State Concerned Member States Cefadroxil 250 mg/5 ml granules for oral suspension Cefadroxil monohydrate Other beta-lactam antibacterials, First-generation cephalosporins ATC code: J01DB05 Granules for oral suspension United Kingdom Austria, Bulgaria, Czech Republic, France, Germany, Poland, Romania, Slovak Republic and Slovenia Marketing Authorisation Number(s) PL 34088/0033 Name and address of the authorisation Alkaloid-INT d.o.o. holder Šlandrova ulica 4, 1231 Ljubljana - Črnuče Slovenia 9

10 III SCIENTIFIC OVERVIEW AND DISCUSSION III.1 QUALITY ASPECTS DRUG SUBSTANCE INN: Cefadroxil monohydrate Chemical Names: (6R,7R)-7-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3-methyl- 8-oxo-5-thia-1-azebicyclo[4,2,0]oct-2-ene-2-carboxylic acid monohydrate. Structure: Molecular formula: C 16 H 17 N 3 O 5 S. H 2 O, Molecular weight: g/mol Physical form: White or almost white powder. Solubility: The substance is slightly soluble in water and very slightly soluble in alcohol. Cefadroxil monohydrate is the subject of a European Pharmacopoeia monograph. All aspects of the manufacture and control of the active substance cefadroxil monohydrate are covered by a European Directorate for the Quality of Medicines and Healthcare (EDQM) Certificate of Suitability. DRUG PRODUCT Other Ingredients Other ingredients consist of the pharmaceutical excipients microcrystalline cellulose, carmellose sodium, sucrose, xanthan gum E415, sodium benzoate E211, citric acid monohydrate, sodium citrate, polysorbate 80 and the orange flavour (flavouring ingredients, maltodextrin, sucrose, soy-lecithin E322, silicon dioxide E551) and colour Quinoline yellow aluminium lake E104. All excipients comply with the relevant European Pharmacopoeia monographs with the exception of the orange flavour and colorant Quinoline yellow aluminium lake E104 which comply with an in-house specification. Satisfactory Certificates of Analysis have been provided for these excipients. The above excipients do not contain materials of animal or human origin. No genetically modified organisms (GMO) have been used in the preparation of this product. Pharmaceutical Development The objective of the pharmaceutical development programme was to develop granules for reconstitution as a suspension containing cefadroxil monohydrate that could be considered a 10

11 generic medicinal product of Baxan 250 mg/5 ml suspension (Bristol Myers Squibb Pharmaceutical Ltd., UK). Suitable pharmaceutical development data have been provided for this application. Comparative dissolution and impurity profiles have been provided for the proposed and originator products. Manufacture Satisfactory batch formula has been provided for the manufacture of the product, along with an appropriate account of the manufacturing process. The manufacturing process has been validated and has shown satisfactory results. Process validation data on commercial batches have been provided. The results are satisfactory. Finished Product Specifications The finished product specification is satisfactory. Test methods have been described and adequately validated. Batch data have been provided and comply with the release specifications. Certificates of Analysis have been provided for any working standards used. Container Closure System The granules for oral suspension are packed in a neutral glass bottle, supplied with an aluminium cap with a polyethylene sealing. The cardboard carton contains one (1) bottle, one plastic measuring cup for reconstitution with a 60 ml, graduation mark; one plastic graduated spoon for dosing, and an instruction leaflet. Each bottle contains 65 g granules for preparation of 100 ml oral suspension (20 spoons of 5 ml). The plastic spoon is graduated on 1.25 ml, 2.5 ml and 5 ml for measuring of the doses. Specifications and Certificates of Analysis for the primary packaging material have been provided. These are satisfactory. All primary packaging is controlled to European Pharmacopoeia standards and complies with relevant guidelines. Stability Finished product stability studies have been conducted in accordance with current guidelines and in the packaging proposed for marketing. Based on the results, a shelf-life of 2 years for unreconstituted product with a storage condition Stored below 25 o C have been set. These are satisfactory. Reconstituted suspension: The product may be stored for 7 days below 30 o C or 21 days in a refrigerator (5 o C + 3 o C). Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labelling The SmPC, PIL and labelling are pharmaceutically satisfactory. A package leaflet has been submitted to the MHRA together with results of consultations with target patient groups ("user testing"), in accordance with Article 59 of Council Directive 2001/83/EC. The results indicate that the package leaflet is well-structured and organised, easy to understand and written in a comprehensive manner. The test shows that the 11

12 patients/users are able to act upon the information that the package leaflet contains. Marketing Authorisation Application (MAA) Form The MAA form is pharmaceutically satisfactory. Expert Report/Quality Overall Summary A quality overall summary has been written by an appropriately qualified person and is a suitable summary of the pharmaceutical aspects of the dossier. Conclusion There are no objections to the approval of this product from a pharmaceutical point of view. III.2 NON-CLINICAL ASPECTS PHARMACODYNAMICS, PHARMACOKINETICS, TOXICOLOGY The pharmacological, pharmacokinetic and toxicological properties of cefadroxil monohydrate are well-known. No new non-clinical data have been supplied with this application and none are required for applications of this type. The non-clinical expert report has been written by an appropriately qualified person and is a suitable summary of the non-clinical aspects of the dossier. A suitable justification has been provided for the non-submission of the environmental risk assessment. There are no objections to the approval of this product from a non-clinical point of view. III.3 CLINICAL ASPECTS CLINICAL PHARMACOLOGY To support this application, the Marketing Authorisation Holder submitted the following bioequivalence study: An open label, single dose, randomised, two-way crossover study comparative bioavailability study of Cefadroxil 250 mg/5 ml suspension (Alycef) by Alkaloid and Baxan 250 mg/5 ml suspension by Bristol Myers Squibb, UK in healthy subjects under fasting conditions. Serial blood samples were collected in each period at Pre-dose and at 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.5, 3.00, 4.00, 6.00, 8.00, 10.00, and post-dose following the drug administration in each period. There was a washout period of 7 days between the two periods of the study and this was sufficient to avoid carryover as evidenced by undetectable levels in the pre-dose samples in period 2. Results Geometric Means and 90% Confidence Interval for Cefadroxil monohydrate (n=18) On Log transformed Data Parameter Cefadroxil Monohydrate (250 mg/5ml) Geometric LSMeans Alycef/Baxan (90% Alycef Baxan C.I.) C max (μ/ml.h) ( ) AUC (0-t) (μ/ml.h) ( ) AUC (0-inf) (μ/ml.h) ( ) 12

13 The 90% confidence intervals for C max and AUC are well within the acceptance range of %. Bioequivalence has been demonstrated between the test formulation (Cefadroxil 250 mg/5 ml suspension) and the reference formulation (Baxan 250 mg/5 ml suspension). EFFICACY No new efficacy data have been submitted and none are required for this application. SAFETY No new safety data have been submitted and none are required for this application. EXPERT REPORT The clinical overview is written by an appropriately qualified physician and is a suitable summary of the clinical aspects of the dossier. SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) The SmPC is medically satisfactory and consistent with that for the reference product. PATIENT INFORMATION LEAFLET The PIL is medically satisfactory and consistent with the SPC. LABELLING The labelling is medically satisfactory. Marketing Authorisation Application (MAA) FORM The MAA form is medically satisfactory. CONCLUSIONS There are no objections to the approval of this product from a clinical point of view. 13

14 IV OVERALL CONCLUSION AND BENEFIT-RISK ASSESSMENT QUALITY The important quality characteristics of Cefadroxil 250 mg/5 ml granules for oral suspension are well-defined and controlled. The specifications and batch analytical results indicate consistency from batch to batch. There are no outstanding quality issues that would have a negative impact on the benefit/risk balance. NON-CLINICAL No new non-clinical data were submitted and none are required for applications of this type. CLINICAL Bioequivalence has been demonstrated between the applicant s Cefadroxil 250 mg/5 ml suspension and the reference product, Baxan 250 mg/5 ml suspension. No new or unexpected safety concerns arise from this application. The SmPC and PIL are satisfactory and consistent with those of the reference product. Satisfactory labelling has also been submitted. RISK-BENEFIT ASSESSMENT The quality of the product is acceptable and no new non-clinical or clinical safety concerns have been identified. Extensive clinical experience with cefadroxil monohydrate is considered to have demonstrated the therapeutic value of the compound. The risk-benefit is therefore considered to be positive. 14

15 Module 6 STEPS TAKEN AFTER INITIAL PROCEDURE - SUMMARY Date submitted Application type Scope Outcome 15

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