Summary Public Assessment Report. Generics

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1 Summary Public Assessment Report Generics 875 mg mg, Film-coated tablets (Amoxicillin Trihydrate + Potassium Clavulanate) Date: /7

2 Summary Public Assessment Report Generics Amoxicillin Trihydrate + Potassium Clavulanate, Film-coated tablet, 875 mg mg. This is a summary of the public assessment report (PAR) for. It explains how was assessed and its authorisation recommended as well as its conditions of use. It is not intended to provide practical advice on how to use. For practical information about using, patients should read the package leaflet or contact their doctor or pharmacist. What is and what is it used for? is a generic medicine. This means that Amoxicilina + Ácido Clavulânico Alter is similar to a reference medicine already authorised in the European Union (EU) called Augmentin Duo, 875mg + 125mg, film-coated tablets. is used in adults and children to treat the following infections: - middle ear and sinus infections - respiratory tract infections - urinary tract infections - skin and soft tissue infections including dental infections - bone and joint infections. How does work? is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to the group of penicillins that can sometimes be made inactive. The other active component (clavulanic acid) stops this from happening. How is used? The pharmaceutical form of is film-coated tablet and the route of administration is oral. Please read section 3 of the PL for detailed information on dosing recommendations, the route of administration, and the duration of treatment. The medicine can only be obtained with a prescription. What benefits of have been shown in studies? Because is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Augmentin Duo, 875mg + 125mg, film-coated tablets. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. 2/7

3 What are the possible side effects of Ácido Clavulânico Alter? Because Ácido Clavulânico Alter is a generic medicine and is bioequivalent to the reference medicine, its benefits and possible side effects are taken as being the same as the reference medicine. For the full list of restrictions, see the package leaflet. Why is Ácido Clavulânico Alter approved? It was concluded that, in accordance with EU requirements, Ácido Clavulânico Alter has been shown to have comparable quality and to be bioequivalent/be comparable to Augmentin Duo, 875mg + 125mg, film-coated tablets. Therefore, INFARMED I.P. decided that, as for Augmentin Duo, 875mg + 125mg, film-coated tablets, the benefits are greater than its risk and recommended that it can be approved for use. What measures are being taken to ensure the safe and effective use of Ácido Clavulânico Alter? A risk management plan has been developed to ensure that Ácido Clavulânico Alter is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ácido Clavulânico Alter, including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously as well. Other information about Ácido Clavulânico Alter The marketing authorisation for Ácido Clavulânico Alter was granted on The full PAR for Ácido Clavulânico Alter can be found on the website For more information about treatment with read the package leaflet or contact your doctor or pharmacist. This summary was last updated in MM-YYYY. 3/7

4 Public Assessment Report Scientific discussion 875 mg mg, Film-coated tablets (Amoxicillin Trihydrate + Potassium Clavulanate) This module reflects the scientific discussion for the approval of Amoxicilina + Ácido Clavulânico Alter. The procedure was finalised at For information on changes after this date please refer to the module Update. 4/7

5 I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have agreed in granting a marketing authorisation for, 875 mg mg, film-coated tablets, from Alter, S.A. The product is indicated for the treatment of the following infections in adults and children: - Acute bacterial sinusitis (adequately diagnosed) - Acute otitis media - Acute exacerbations of chronic bronchitis (adequately diagnosed) - Community acquired pneumonia - Cystitis - Pyelonephritis - Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with - spreading cellulitis. - Bone and joint infections, in particular osteomyelitis. A comprehensive description of the indications and posology is given in the SmPC. The originator product is Augmentin Duo, 875mg + 125mg, film-coated tablets by Glaxosmithkline Produtos Farmacêuticos, Lda, registered since The marketing authorisation has been granted pursuant to Article 10.1 of Directive 2001/83/EC. II. QUALITY ASPECTS II.1 Introduction, 875 mg mg, film-coated tablets, are white to off-white film coated capsule shaped tablets debossed with RX509 on one side and score line on the other. Each tablet contains mg Amoxicillin trihydrate equivalent to 875 mg Amoxicillin and mg of Potassium clavulanate equivalent to 125 mg Clavulanic acid. tablets are available in PVC/PVdC/Alu blister pack in pouch (Polyester film/aluminium foil/polyester film/polyethylene) with 1g sachet containing molecular sieve. The excipients are Cellulose microcrystalline, Sodium starch glycolate, Silica colloidal anhydrous, Povidone, Eudragit E100, Magnesium stearate, Hypromellose, Titanium dioxide (E171), Macrogol 400, Talc. II.2 Drug Substance The chemical-pharmaceutical documentation and Expert Report in relation amoxicillin trihydrate and to potassium clavulanate are of sufficient quality in view of the present European regulatory requirements. II.3 Medicinal Product The documentation provided complies with relevant EU guidelines and directives. Manufacture is performed in accordance with cgmp and consistency in quality and homogeneity is demonstrated. 5/7

6 The finished product specification is based on relevant development and stability studies. The development of the product has been described, the choice of excipients is justified and their functions explained. Appropriate validation data have been provided for the analytical methods. Batch analyses data support the proposed finished product specification. The conditions used in the stability studies are according to the ICH stability guideline. The control tests and specifications for drug product are adequately drawn up. The proposed shelf-life of 24 months for the drug product, stored below 25ºC, in the original package to protect from light, is considered acceptable. III. NON-CLINICAL ASPECTS Pharmacodynamic, pharmacokinetic and toxicological properties of amoxicillin and clavulanic acid are well known. As amoxicillin and clavulanic acid are widely used, well-known active substances, the applicant has not provided additional studies and further studies are not required. An overview based on literature review is, thus, appropriate. The non-clinical overview on the pre-clinical pharmacology, pharmacokinetics and toxicology is adequate. Environmental Risk Assessment (ERA) An Environmental Risk Assessment has not been performed as the product is intended for generic substitution. A disposal advice has been added to the SmPC. IV. CLINICAL ASPECTS One bioequivalence study in single dose fed conditions for, 875 mg + 125mg, Film-coated Tablets, was included in the present application. Augmentan Filmtabletten 875/125 mg manufactured by SmithKline Beecham plc. T/A Smithkline Beecham Pharmaceuticals, was the reference product. The bioequivalence has been proved. Pharmacovigilance System Summary According with the new legislation for Pharmacovigilance applied in the European Union (EU), the Applicant has submitted the Pharmacovigilance System Summary. Risk Management Plan This application is not an application for a new active substance, or for a similar biological medicinal product. It is an application for generic medicinal product where a safety concern requiring additional risk minimisation activities has not been identified with the reference medicinal product. This MAA is for an essentially similar Medicinal Product with the same Summary of the Product Characteristics (SmPC) as the innovator s Product. In view of the above an EU-RMP is not being submitted with this Marketing Authorisation Application. This was considered acceptable by the RMS. V. USER CONSULTATION A user consultation with target patient groups on the package information leaflet (PIL) has been performed on the basis of a bridging report, which has been found acceptable. 6/7

7 VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION Based on the review of the data on quality, safety and efficacy, the RMS considers that the application for, 875 mg mg, film-coated tablets is approvable. 7/7

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