Public Assessment Report. Decentralised Procedure. Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution

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1 Public Assessment Report Decentralised Procedure Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution (ipratropium bromide monohydrate) Procedure No: UK Licence No: PL 36390/0083 Cipla (EU) Limited 1

2 LAY SUMMARY Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution (ipratropium bromide monohydrate; pressurised inhalation, solution; 20 micrograms per actuation) This is a summary of the Public Assessment Report (PAR) for Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution (PL 36390/0083; ). It explains how Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution 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 Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution. For practical information about using Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution, patients should read the package leaflet or contact their doctor or pharmacist. The product may be referred to as Ipravent CFC-Free Inhaler in this report. What is Ipravent CFC-Free Inhaler and what is it used for? Ipravent CFC-Free Inhaler contains the active substance ipratropium bromide (as ipratropium bromide monohydrate). Ipravent CFC-Free Inhaler is used to make breathing easier for people with asthma or chronic obstructive pulmonary disease (COPD), often referred to as chronic bronchitis. Ipravent CFC-Free Inhaler is not to be used in children, 12 years of age and younger or adolescents 13 to 17 years of age. Ipravent CFC-Free Inhaler is a hybrid medicine. This means that Ipravent CFC-Free Inhaler contains the same active substance as, and is similar to, a reference medicine already authorised in the European Union (EU) called Atrovent dosis-aërosol 20 μg/dosis, aërosol, oplossing (NL RVG 2683; Boehringer Ingelheim B.V) first approved in the Netherlands in a chlorofluorocarbon (CFC)-free hydrofluoroalkane (HFA)-containing formulation in November The corresponding reference product in the UK is ATROVENT Inhaler CFC-Free 20 micrograms/actuation pressurised inhalation solution (Boehringer Ingelheim Limited, UK; PL 00015/0266), approved in the UK on 01 March How is Ipravent CFC-Free Inhaler used? Ipravent CFC-Free Inhaler is inhaled through the mouth. The product is not to be used with any spacing device. The usual recommended dose is 1 or 2 puffs to be inhaled three or four times daily. However, in early treatment some patients may need up to 4 puffs at a time to obtain maximum effect. The recommended dose should not be exceeded. Ipravent CFC-Free Inhaler can only be obtained on prescription. How does Ipravent CFC-Free Inhaler work? The active substance, ipratropium bromide, belongs to a group of medicines called bronchodilators. In asthma or COPD, patients may have difficulty in breathing, shortness of breath, wheezing or tightness in the chest. Ipravent CFC-Free Inhaler works by opening up airways. 2

3 How has Ipravent CFC-Free Inhaler been studied? As Ipravent CFC-Free Inhaler is a hybrid medicine, studies in patients have been limited to tests to determine it is therapeutically equivalent to the reference medicine, ATROVENT Inhaler CFC-Free 20 micrograms/actuation pressurised inhalation solution (Boehringer Ingelheim Limited, UK). Two medicines are therapeutically equivalent when they produce the same measure of therapeutic effect in the body. In addition the company provided data from the published literature on ipratropium bromide. What are the benefits and risks of Ipravent CFC-Free Inhaler? Because Ipravent CFC-Free Inhaler is a hybrid medicine and is therapeutically equivalent to the reference medicine, its benefits and risks are taken as being the same as those of the reference medicine. Why is Ipravent CFC-Free Inhaler approved? It was concluded that, in accordance with EU requirements, Ipravent CFC-Free Inhaler has been shown to have comparable quality and to be therapeutically equivalent to ATROVENT Inhaler CFC-Free 20 micrograms/actuation pressurised inhalation solution (Boehringer Ingelheim Limited, UK). Therefore, the view was that, as for ATROVENT Inhaler CFC-Free 20 micrograms/actuation pressurised inhalation solution (Boehringer Ingelheim Limited, UK), the benefit outweighs the identified risk. What measures are being taken to ensure the safe and effective use of Ipravent CFC-Free Inhaler? Safety information has been included in the Summary of Product Characteristics and the package leaflet for Ipravent CFC-Free Inhaler, including the appropriate precautions to be followed by healthcare professionals and patients. Other information about Ipravent CFC-Free Inhaler A Marketing Authorisation was granted in the UK on 05 November The full PAR for Ipravent CFC-Free Inhaler follows this summary. For more information about treatment with Ipravent CFC-Free Inhaler, read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in January

4 TABLE OF CONTENTS Module 1: Information about the initial procedure Page 5 Module 2: Summary of Product Characteristics Page 6 Module 3: Patient Information Leaflet Page 7 Module 4: Labelling Page 8 Module 5: Scientific discussion during the initial procedure Page 11 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 18 4

5 Module 1 Information about the initial procedure Product Name Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution Type of Application Generic, Article 10(3) Active Substance Ipratropium bromide (as ipratropium bromide monohydrate) Form Pressurised inhalation, solution Strength MA Holder 20 micrograms per actuation Cipla (EU) Limited Hillbrow House Hillbrow Road Esher Surrey KT10 9NW United Kingdom Reference Member State (RMS) UK Concerned Member State (CMS) Ireland Procedure Number Timetable Day October

6 Module 2 Summary of Product Characteristics In accordance with Directive 2010/84/EU, the Summaries of Product Characteristics (SmPCs) for products granted Marketing Authorisations at a national level are available on the MHRA website. 6

7 Module 3 Patient Information Leaflet In accordance with Directive 2010/84/EU, the Patient Information Leaflets (PILs) for products granted Marketing Authorisations at a national level are available on the MHRA website. 7

8 Module 4 Labelling The Marketing Authorisation Holder has submitted the text version only and has committed to submitting mock-up livery to the relevant regulatory authorities for approval before packs are marketed. 8

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11 Module 5 Scientific discussion during initial procedure I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the UK and Ireland considered that the application for Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution (PL 36390/0083; ) could be approved. Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution may be referred to as Ipravent CFC free Inhaler in this report. The product is a prescription-only medicine (POM). Ipravent CFC free Inhaler is indicated for the regular treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD) and chronic asthma. Ipravent CFC free Inhaler is not indicated for use in children, 12 years of age and younger or adolescents 13 to 17 years of age. The product is not to be used with any spacing device. If a spacing device is required, the patient s inhaler treatment will have to be changed to an alternative inhaler that can be used with a spacing device. The applicant has provided a post-authorisation commitment to develop a spacing device for use with Ipravent CFC free Inhaler. The application was submitted using the Decentralised Procedure (DCP), with the UK as Reference Member State (RMS) and Ireland as Concerned Member State (CMS). The application was submitted under Article 10(3) of Directive 2001/83/EC, as amended, as a hybrid application. The reference medicinal product for this application is Atrovent dosis-aërosol 20 μg/dosis, aërosol, oplossing (Boehringer Ingelheim B.V., Netherlands) first approved in the Netherlands on 14 November The corresponding reference product in the UK is ATROVENT Inhaler CFC-Free 20 micrograms/actuation pressurised inhalation, solution (PL 00015/0266; Boehringer Ingelheim Limited, UK), which was approved in the UK on 01 March Prior to March 2004, Atrovent (ipratropium bromide) had been available in the UK as a CFC-containing pressurised metered dose inhaler (pmdi; Marketing Authorisation Holder: Boehringer Ingelheim Limited, UK), which has been replaced with the CFC-free, HFA-containing, orally inhaled reference product. Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution contains the active ingredient, ipratropium bromide (as ipratropium bromide monohydrate), a quaternary ammonium compound. Ipratropium bromide is a synthetic anticholinergic agent which acts as a non-selective antagonist at the muscarinic receptor. When inhaled orally, ipratropium bromide blocks M1, M2 and M3 muscarinic receptors located on airway smooth muscle, producing relaxation of smooth muscle and bronchodilation. Bronchodilation is primarily a local effect and is not due to systemic absorption. Ipratropium bromide is a short-acting bronchodilator. A single-dose pharmacokinetic (bioequivalence) study was submitted to support this application, comparing the applicant s test product Ipratropium bromide HFA pmdi (containing ipratropium bromide 20 micrograms/actuation) with the reference product Atrovent CFC-free (containing ipratropiun bromide 20 micrograms/actuation; Boehringer Ingelheim Limited, UK) in healthy adult male human subjects under fasting conditions. The study was conducted according to the current version of the Principles of Declaration of Helsinki (Revised Seoul, October 2008) and in compliance with the current ICH GCP, OECD GLP, National Regulations (ICMR Guidelines), Indian GCP and Schedule Y of Indian Drugs and Cosmetic Act, the European Guideline on bioequivalence (CPMP/QWP/EWP/1401/98 Rev. 1, dated January 2010) and the CHMP Guideline on orally inhaled products (CPMP/EWP/4151/00 Rev. 1, dated January 2009). With the exception of the clinical pharmacokinetic study, no new non-clinical or clinical efficacy studies were performed for this application, which is acceptable given that this is a hybrid application based on 11

12 an originator product that has been in clinical use for over 10 years. The non-clinical dossier consists of published literature and this is acceptable. The RMS has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place at all sites responsible for the manufacture, assembly and batch release 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 and CMS considered that the application could be approved at the end of procedure (Day 210) on 06 October After a subsequent national phase, a licence was granted in the UK on 05 November II. ABOUT THE PRODUCT Name of the product in the Reference Ipravent CFC-Free Inhaler 20 micrograms per Member State actuation pressurised inhalation, solution Name(s) of the active substance(s) (INN) Ipratropium bromide (as ipratropium bromide monohydrate) Pharmacotherapeutic classification Anticholinergic bronchodilator (ATC code) (ATC code: R03B B01) Pharmaceutical form and strength Pressurised inhalation, solution; 20 micrograms per actuation Reference number for the Decentralised Procedure Reference Member State (RMS) United Kingdom Concerned Member States (CMS) Ireland Marketing Authorisation Number PL 36390/0083 Name and address of the authorisation Cipla (EU) Limited holder Hillbrow House Hillbrow Road Esher Surrey KT10 9NW United Kingdom III SCIENTIFIC OVERVIEW AND DISCUSSION III.1 QUALITY ASPECTS ACTIVE SUBSTANCE INN: Ipratropium bromide Chemical Name: (1R,3r,5S,8r)-3-[(RS)- (3-hydroxy-2-phenylpropanoyl)oxy]-8-methyl-8-(1 -methylethyl)-8- azoniabicyclo[3.2.1]octane bromide Molecular formula: C 20 H 30 BrNO 3 H 2 O Structure: Molecular mass: Appearance: A white or almost white crystalline powder Solubility: Soluble in water, freely soluble in methanol and slightly soluble in ethanol. 12

13 Ipratropium bromide is the subject of a European Pharmacopoeia monograph. All aspects of the manufacture and control of the active substance, ipratropium bromide, are covered by a European Directorate for the Quality of Medicines and Healthcare (EDQM) Certificate of Suitability. MEDICINAL PRODUCT Other Ingredients Other ingredients consist of the pharmaceutical excipients 1, 1, 1, 2-tetrafluoroethane (HFA 134a), ethanol anhydrous, purified water and citric acid anhydrous. Appropriate justification for the inclusion of each excipient has been provided. All excipients comply with their respective European Pharmacopoeia monographs, with the exception of 1, 1, 1, 2-tetrafluoroethane (HFA 134a) which is controlled to a suitable in-house specification. Certificates of Analysis have been provided for all excipients, showing compliance with their respective specifications. None of the excipients contain materials of animal or human origin. No genetically modified organisms (GMO) have been used in the preparation of these excipients. Pharmaceutical Development The objective of the pharmaceutical development programme was to produce a safe, efficacious pressurised inhalation, solution that was comparable in performance to the originator product, Atrovent Inhaler CFC-Free 20 micrograms/actuation pressurised inhalation, solution (Boehringer Ingelheim Limited). Suitable pharmaceutical development data have been provided for this application. Comparative in-vitro data have been provided for this product and the reference product. Manufacturing Process A 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 with full production-scale batches that have shown satisfactory results. Control of Finished Product The finished product specification is acceptable. Test methods have been described and have been validated adequately. Batch data have been provided, which comply with the release specification. Certificates of Analysis have been provided for all working standards used. Container-Closure System The product is supplied in 19 ml pressurised pure aluminium anodized canisters (containing 12.8 ml of solution) sealed with 50 µl metering valves made up of thermoplastic and plastic actuators made up of polypropylene, having white mouthpieces fitted with green mouthpiece covers. The product is available in a pack size of one canister. Each canister contains 200 metered actuations of 20 micrograms of ipratropium bromide. Satisfactory specifications and Certificates of Analysis for the primary packaging material have been provided. All primary packaging is controlled to European Pharmacopoeia standards that comply with guidance concerning materials in contact with foodstuff. 13

14 Stability of the Product Finished product stability studies were performed in accordance with current guidelines on batches of finished product in the packaging proposed for marketing. The data from these studies support a shelf-life of 24 months, with the storage instructions Do not store above 25 C. Protect from direct sunlight, heat and frost. The canister contains a pressurised liquid. Do not expose to temperatures higher than 50 C. Do not pierce the canister. Suitable post approval stability commitments have been provided to continue stability testing on batches of finished product. Bioequivalence/Bioavailability Satisfactory Certificates of Analysis have been provided for the test and reference batches used in the bioequivalence study. The bioequivalence study is discussed in Section III.3, Clinical Aspects. Summary of Product Characteristics (SmPC), Product Information Leaflet (PIL) and Labels The SmPC, PIL and labels are satisfactory from a pharmaceutical perspective. Final text versions of the labelling and PIL have been provided. The Marketing Authorisation Holder has committed to submitting mock-ups to the relevant competent authorities for approval before marketing any pack size. Marketing Authorisation Application (MAA) Form The MAA form is satisfactory from a pharmaceutical perspective. Expert Report (Quality Overall Summary) The quality overall summary has been written by an appropriately qualified person and is a suitable summary of the pharmaceutical aspects of the dossier. Conclusion The grant of a Marketing Authorisation is recommended. III.2 NON-CLINICAL ASPECTS As the pharmacodynamic, pharmacokinetic and toxicological properties of ipratropium bromide are well-known, no new non-clinical data have been submitted and none are required. The applicant s non-clinical expert report has been written by an appropriately qualified person and is satisfactory, providing an appropriate review of the relevant non-clinical pharmacology, pharmacokinetics and toxicology. Suitable justification has been provided for non-submission of an Environmental Risk Assessment. As the application is to substitute for an already authorised product, it is not expected that environmental exposure will increase following approval of the Marketing Authorisation for the proposed product. The grant of a Marketing Authorisation is recommended. III.3 CLINICAL ASPECTS Clinical Pharmacololgy The clinical pharmacology of ipratropium bromide is well-known. With the exception of data from the pharmacokinetic study detailed below, no new pharmacodynamic or pharmacokinetic data are provided or required for this application. In support of the application, the Marketing Authorisation Holder submitted the following pharmacokinetic (bioequivalence) study to demonstrate therapeutic equivalence between the test product and the reference product. The CHMP Guideline for orally inhaled products (CPMP/EWP/4151/00 14

15 Rev. 1) states that pharmacokinetic studies should be carried out in the intended patient population; the applicant has provided suitable justification for carrying out the study in healthy adult volunteers. A randomised, single dose, open label, two-treatment, two-period, two-sequence, crossover bioequivalence study comparing the test product Ipratropium bromide HFA pmdi (containing ipratropium bromide 20 micrograms/actuation; Cipla Limited) with the reference product Atrovent CFC-free (containing ipratropiun bromide 20 micrograms/actuation; Boehringer Ingelheim Limited, UK), both administered as 4 puffs in healthy adult male human subjects under fasting conditions. The subjects self-administered (orally inhaled) a single dose (4 x 20 micrograms per actuation/puff; 80 micrograms) of either the test or the reference product on the two treatment days in a cross-over fashion as per the randomisation sequence, after at least a 10-hour overnight fast. A dose of 80 micrograms was chosen as 80 micrograms is the highest recommended single dose of the reference product. Spacing devices were not used. Blood samples were collected pre-dose and up to 24 hours after each administration. The washout period between the treatment arms was six days. The pharmacokinetic results are presented below. Pharmacokinetic parameters (geometric means, ratios and 90% confidence intervals (CI)) for ipratropium bromide Pharmacokinetic Geometric Mean *(%)T/R 90% Confidence Parameters Test (T) Reference (R) Interval C max (pg/ml) AUC 0-t (hr.pg/ml) C max maximum plasma concentration AUC 0-t area under the plasma concentration-time curve from time zero to t hours *(%) T/R is ratio Test Geometric Least Square Mean/Reference Geometric Least Square Mean Ratios and 90% CI calculated from ln-transformed data Conclusion of study The pharmacokinetic parameters measured in this study are appropriate parameters to measure in the assessment of therapeutic equivalence between two orally inhaled products. The pulmonary available dose is reflected through measurement of AUO 0-t and the regional pulmonary deposition through the measurement of C max. The results demonstrate that the pulmonary available dose (via AUO 0-t ) and regional lung deposition (via C max ) are similar between the test and reference product. The 90% CI for the least square mean ratio of the test product to the reference product for both AUO 0-t and C max lie within the acceptable limits of 80.00% to %, in line with the Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev 1/Corr**). Thus, the data support the claim that the applicant s test product is bioequivalent to, and thus therapeutically equivalent to, the reference product under fasting conditions. Efficacy The efficacy of ipratropium bromide is well-known. No new efficacy data have been submitted and none are required for this type of application. 15

16 Safety With the exception of the safety data generated during the bioequivalence study, no new safety data were submitted and none are required for this type of application. No new or unexpected safety issues arose during the bioequivalence study. Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labels The SmPC, PIL and labels are acceptable from a clinical perspective. The PIL is consistent with the details in the SmPC and in line with current guidance. The labelling is in line with current guidance. Clinical Expert Report (Clinical Overview) The clinical overview has been written by an appropriately qualified physician and is a suitable summary of the clinical aspects of the dossier. Pharmacovigilance System and Risk Management Plan The Pharmacovigilance System, as described by the MAH, fulfils the requirements and provides adequate evidence that the MAH 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. Suitable justification has been provided for non-submission of a Risk Management Plan (RMP) for this application which was received prior to the date (21 July 2012) when the pharmacovigilance regulations in accordance with Directive 2010/84/EU came into force. Conclusion The grant of a Marketing Authorisation is recommended. IV OVERALL CONCLUSION AND BENEFIT/RISK ASSESSMENT QUALITY The important quality characteristics of Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution 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. As the pharmacokinetics, pharmacodynamics and toxicology of ipratropium bromide are well-known, no additional data were required. EFFICACY With the exception of the bioequivalence study, no new data were submitted and none are required for this type of application. Therapeutic equivalence has been demonstrated between the applicant s test product and the reference product Atrovent CFC-free (containing ipratropiun bromide 20 micrograms/actuation; Boehringer Ingelheim Limited, UK). SAFETY With the exception of the safety data generated from the bioequivalence study, no new data were submitted and none are required for this type of application. As the safety profile of ipratropium bromide is well known, no additional safety data were required. No new or unexpected safety concerns arose from the pharmacokinetic study. 16

17 PRODUCT LITERATURE The SmPC, PIL and labelling text is satisfactory and consistent with that for the reference product, where appropriate and are in line with current guidance. BENEFIT/RISK ASSESSMENT The quality of the product is acceptable, and no new non-clinical or clinical safety concerns have been identified. Extensive clinical experience with ipratropium bromide is considered to have demonstrated the therapeutic value of the compound. The benefit/risk balance is, therefore, considered to be positive. 17

18 Module 6 STEPS TAKEN AFTER THE INITIAL PROCEDURE - SUMMARY Date submitted Application type Scope Outcome 18

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