Summary Public Assessment Report. Generics. Triflu Paracetamol, Ascorbic acid, Pheniramine maleate MT/H/0172/001/DC

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1 CMDh/305/2013 July 2014, Rev.01 Summary Public Assessment Report Generics Triflu Paracetamol, Ascorbic acid, Pheniramine maleate MT/H/0172/001/DC Date: 17 th August, 2016 Summary PAR Generics 1/3

2 Summary Public Assessment Report Generics Triflu Paracetamol, Ascorbic Acid, Pheniramine Maleate 500 mg/200 mg/ 25 mg granules for oral solution in sachet This is a summary of the public assessment report (PAR) for Triflu. It explains how Triflu 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 Triflu. For practical information about using Triflu, patients should read the package leaflet or contact their doctor or pharmacist. What is Triflu and what is it used for? Triflu is a generic medicine. This means that Triflu is similar to a reference medicine already authorised in the European Union (EU) called Fervex, granules en sachets. Triflu is used in the treatment of symptoms associated with the common cold, influenza and upper respiratory tract infections such as runny nose, watery eyes, sneezing, headache and/or fever. How does Triflu work? Triflu contains an antihistamine which reduces runny nose, watery eyes and sneezing together with inflammation. Paracetamol reduces fever and pain associated with the common cold. Ascorbic acid (Vitamin C) is an antioxidant which protects against infection. How is Triflu used? The pharmaceutical form of Triflu is granules for oral solution 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. Triflu is indicated for adults and children older than 15 years. The recommended dose is one sachet 2 or 3 times per day. The interval has to be at least 4 hours between 2 doses. Do not take more than 3 sachets per day. Dissolve content of the sachet must be dissolved in cold or warm water. In case of flu it is best to take Triflu dissolved in warm water in the evening. Summary PAR Generics 2/3

3 If you have kidney problems the interval between 2 doses will be determined by your doctor. The maximum period of treatment is 5 days without seeking the medical advice. The medicine can be obtained without a prescription. What benefits of Triflu have been shown in studies? Because Triflu is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Fervex. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. The company provided data from the published literature on paracetamol, ascorbic acid and pheniramine maleate. What are the possible side effects of Triflu? Because Triflu 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 Triflu approved? It was concluded that, in accordance with EU requirements, Triflu has been shown to have comparable quality and to be bioequivalent/be comparable to Fervex. Therefore, the Medicines Authority decided that, as for Fervex, 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 Triflu? A risk management plan has been developed to ensure that Triflu 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 Triflu, 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 Triflu The marketing authorisation for Triflu was granted on the 11 th of May, The full PAR for Triflu can be found on the website For more information about treatment with Triflu, read the package leaflet or contact your doctor or pharmacist. This summary was last updated in August, 2016 Summary PAR Generics 3/3

4 CMDh/223/2005 February 2014 Public Assessment Report Scientific discussion Triflu Paracetamol, Ascorbic acid, Pheniramine maleate MT/H/0172/001/DC Date: 17 th August, 2016 This module reflects the scientific discussion for the approval of Triflu. The procedure was finalised on the 19 th of April, For information on changes after this date please refer to the module Update.

5 I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have granted a marketing authorisation for Triflu 500 mg/200 mg/ 25 mg, granules for oral solution, from Dr. Max Pharma Limited. The product is indicated for the relief of symptoms associated with the common cold, influenza and upper respiratory tract infections in adults and children older than 15 years. A comprehensive description of the indications and posology is given in the SmPC. The marketing authorisation has been granted pursuant to Article 10(1) of Directive 2001/83/EC. The reference product for this application is Fervex granules in sachets authorised by the French NCA in The Marketing Authorisation Holder is Upsa Conseil. The CMSes involved in this procedure were CZ, PL and SK. The product is an over the counter medicine. II. II.1 QUALITY ASPECTS Introduction Each sachet of Triflu granules for oral solution contains 500 mg paracetamol, 200 mg ascorbic acid, 25 mg pheniramine maleate. The excipients are the following: Sucrose Carribbean flavour Citric acid anhydrous Acacia, spray-dried Saccharin sodium (E954) The medicinal product is pack in paper/al/pe sachets. Sachets are packaged in printed carton. The following pack sizes are authorised: 2, 4, 5, 6, 8, 10, 12, 14, 15, 16, 18 and 20 sachets. II.2 Drug Substance The chemical-pharmaceutical documentation and Quality Overall Summary in relation to Triflu hotdrink granules for oral solution are of sufficient quality in view of the present regulatory requirements. The three drug substances, Paracetamol, Ascorbic Acid and Pheniramine Maleate are all existing active substances described in the Ph. Eur version 8.2. The manufacturer of the drug substance Paracetamol has been granted a certificate of suitability with a retest period of 5 years if stored in a polyethylene liner placed in a fibre drum. The manufacturer of ascorbic acid has also been granted a certificate of suitability issued by the EDQM and no retest period has been provided in the certificate. In both cases paracetamol, monograph 0049 and ascorbic acid, monograph 0253 are both considered to be suitably controlled. PAR Scientific discussion 2/7

6 For the other drug substance (pheniramine maleate) an ASMF procedure is used. The control tests and specifications for drug substances are adequately drawn up. Stability studies have been provided for Pheniramine Maleate drug substance based on the submitted stability data, a retest period of 24 months with storage condition Store protected from light is acceptable. With respect to ascorbic acid, evaluation has been done by the manufacturer according to European monograph published in version 7.0. All the results show that it is stable at least 36 months at 25 C / 60% RH when stored under normal conditions (protected from light, moisture and air. Stability studies show that the drug substance Ascorbic acid is also stable at 40 C/75% RH for 6 months. No data was submitted for Paracetamol drug substance since this is covered by the CEP and a retest period of 5 years if stored in a polyethylene liner placed in a fibre drum is acceptable. II.3 Medicinal Product The development of the product has been described, the choice of excipients is justified and their functions explained. All excipients used in the manufacturing are well known and are all (except for the flavouring agent) controlled through the Ph. Eur. No issues with respect to safety are expected. Furthermore, assessment of the physical compatibility data as well as the accelerated studies referred to do not give any indication of potential interactions. The product specifications cover appropriate parameters for this dosage form. Validations of the analytical methods have been presented. Batch analysis has been performed on 2 batches. The batch analysis results show that the finished products meet the specifications proposed. 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. A shelf-life of 21 months with not exceeding 25 C for the drug product is accepted at this time. III. III.1 NON-CLINICAL ASPECTS Introduction Pharmacodynamic, pharmacokinetic and toxicological properties of paracetamol / ascorbic acid and pheniramine maleate are well known. As paracetamol / ascorbic acid and pheniramine maleate are well-known substances, no further studies are required and the applicant provides none. Overview based on literature review is, thus, appropriate. III.2 Ecotoxicity/environmental risk assessment (ERA) Paracetamol / ascorbic acid and pheniramine maleate 500mg/200mg/25mg granules for oral solution in sachets is a generic medicinal product. The reference product of this application is FERVEX, granulés en sachets registered in France. Since the reference product is not authorised in both the RMS and the CMS the European Reference Product is being referred to. It therefore follows that paracetamol / ascorbic acid and pheniramine maleate 500mg/200mg/25mg granules for oral solution in sachets will not be intended for generic substitution in the RMS and CMS. PAR Scientific discussion 3/7

7 Therefore an environmental risk assessment is therefore deemed necessary in line with European Union (EU) guidance EMEA/CPMP/SWP/4447/00, 01 June Paracetamol / ascorbic acid and pheniramine maleate is expected to enter the water system after patient use and potentially could be spread on land from the disposal of sewage treatment plant sludge. Paracetamol / ascorbic acid and pheniramine maleate does not enter the atmosphere based on its physical chemistry. Local regulations supporting disposal of unused medicines should be followed by patients, doctors and pharmacies. Based on the labelling criteria the active ingredient, paracetamol / ascorbic acid and pheniramine maleate is not considered an environmental hazard and should not be labelled as such. Summary of main study results PAR Scientific discussion 4/7

8 Conclusions on studies: Considering the above data, paracetamol / ascorbic acid and pheniramine maleate is not expected to pose a risk to the environment. III.3 Discussion on the non-clinical aspects The application is made under reference to article 10(1) of Directive 2001/83/EC as amended. Abridged applications avoid the need for repetitive tests on animals and humans. IV. IV.1 CLINICAL ASPECTS Introduction Biowaiver The applicant has requested a biowaiver for Triflu hotdrink granules for oral solution and has provided a justification in accordance with the Guideline on the investigation of bioequivalence CPMP/EWP/QWP/1401/98 Rev. 1/Corr** Paracetamol is classified as a BCS class I active substance by the WHO. In the past it has been classified as a BCS class III active substance, however had a positive recommendation for a biowaiver. Ascorbic acid is classified as a BCS class I active substance by the WHO. Pheniramine has not been classified to a specific BCS class, however a very structurally and therapeutically active substance, chlorpheniramine, belongs to the BCS class I. PAR Scientific discussion 5/7

9 The pharmaceutical form is the same as the one of the reference product, i.e. granules for oral solution, in sachets. They both are oral solutions at the time of administration. The excipients are the same as those of the reference product and do not affect gastrointestinal transit, absorption, solubility and in-vivo stability of the active substances. The solubility of active substances has been demonstrated. The experimental studies conducted according to the Guideline on the investigation of Bioequivalence CPMP/EWP/QWP/1401/98 Rev. 1 (20 January 2010) Appendix III - III Drug Substance showed that the 3 active ingredients are totally solubilised at the defined concentrations (500 mg / 250 ml for paracetamol, 200 mg / 250 ml for ascorbic acid and 25 mg / 250 ml for pheniramine maleate) in buffer at ph 1.2, ph 4.1 (pka of ascorbic acid), ph 4.2 (pka of pheniramine), ph 4.5 and ph 6.8 at 37 C (refer to Module 3.2.P.2 for details). Qualitative similarity of test and reference products with respect to dissolution behaviour is demonstrated (refer to Module 3.2.P.2 for details). As a result, a bioequivalence study is not required, since the proposed medicinal product is an oral solution at the time of administration and does not contain any different excipients that will result in differences in the absorption and the bioavailability compared to the originator. The applicant has not conducted any clinical studies for the application. Instead appropriate data is provided to support the claim that the proposed product is essentially similar to the originator. The qualitative composition is identical with that of the originator and the applicant s proposed SmPC is compliant with the reference product with no novel claims or dose recommendations. IV.2 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 Triflu. Summary table of proposed pharmacovigilance activities and proposed risk minimisation activities by safety concern. PAR Scientific discussion 6/7

10 There are no additional concerns and risk minimisation activities regarding the RMP submitted for this product. IV.3 Discussion on the clinical aspects The application is made under reference to article 10(1) of Directive 2001/83/EC as amended. Abridged applications avoid the need for repetitive tests on animals and humans. V. USER CONSULTATION Include a clear statement whether the readability test was accepted or not. The following could be used 1) 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. The test consisted of: a pilot test with 2 participants, followed by two rounds with 10 participants each. The questions covered the following areas sufficiently: traceability, comprehensibility and applicability. 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 Triflu hotdrink, in the treatment of the relief of symptoms associated with the common cold, influenza and upper respiratory tract infections, is approvable. Post approval commitment not falling under Article 21a or 22: The applicant will implement holding times when the results of the stability study including holding times will be completed and within specification. PAR Scientific discussion 7/7

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