Public Assessment Report. Scientific discussion. Ramipril Teva 1.25 mg, 2.5 mg, 5 mg and 10 mg tablets Ramipril DK/H/2130/ /DC.

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1 Public Assessment Report Scientific discussion Ramipril Teva 1.25 mg, 2.5 mg, 5 mg and 10 mg tablets Ramipril DK/H/2130/ /DC 3 April 2014 Tis module reflects te scientific discussion for te approval of Ramipril Teva. Te procedure was finalised on 13 Marc For information on canges after tis date please refer to te module Update.

2 I. INTRODUCTION Based on te review of te quality, safety and efficacy data, te Member States ave granted a marketing autorisation for Ramipril Teva 1.25 mg, 2.50 mg, 5 mg and 10 mg tablets, from Teva Denmark A/S. Te product is indicated for treatment of ypertension, renal desease and symptomatic eart failure, cardiovascular prevention and secondary prevention after acute myocardial infarction. A compreensive description of te indications and posology is given in te SmPC. Ramipril is an angiotensin-converting enzyme (ACE) inibitor tat requires cleavage of an ester group to form te active metabolite ramiprilat wic inibits te conversion of angiotensin I to te more active angiotensin II. Tis decentralised procedure concerns a generic application claiming essential similarity wit te reference product Triatec 1.25 mg, 2.5 mg, 5 mg and 10 mg tablets, wic as been registered in Denmark by Sanofi-aventis Denmark A/S since January Triatec 10 mg tablets are no longer registered in Denmark. Triatec 10 mg is autorised in te form of ard capsules by sanofi-aventis Denmark A/S since November Te reference products used for te bioequivalence studies are Delix 2.5 mg tablets, Hoecst AG and Delix protect 10 mg tablets, Aventis Parma Deutscland GmbH, bot from te German market. Te marketing autorisation as been granted pursuant to Article 10(1) of Directive 2001/83/EC. II. QUALITY ASPECTS II.1 Introduction Eac tablet contains ramipril 1.25 mg, 2.5 mg, 5 mg or 10 mg. Te 1.25 mg tablets are yellow, oblong, biplane tablets, 8.0 mm x 4.0 mm. Te 2.5 mg tablets are yellow, capsule-saped, un-coated, flat tablets, 10.0 x 5.0 mm, scored on one side and side walls, marked R2. Te 5 mg tablets are pink, capsule-saped, un-coated, flat tablets, 8.8 x 4.4 mm, scored on one side and side walls, marked R3. Te 10 mg tablets are wite to off-wite, capsule-saped, un-coated, flat tablets, 11.0 x 5.5 mm, scored on one side and side walls, marked R4. Te 2.5 mg, 5 mg and 10 mg tablets can be divided into equal alves. Te tablets are packed in blister packs of OPA/Al/PVC-Al in pack sizes of 7, 20, 21, 28, 30, 50, 56, 60, 90, 98, 100 and 50x1 tablets. However, not all pack sizes may be marketed. Te excipients in te tablets are: sodium ydrogen carbonate; lactose monoydrate; croscarmellose sodium; starc, pregelatinised (from maize starc); sodium stearyl fumarate; iron oxide yellow (E172) (1.25 mg, 2.5 mg and 5 mg tablets only) and iron oxide red (E172) (5 mg tablets only). Te RMS as been assured tat acceptable standards of GMP (see Directive 2003/94/EC) are in place for tis product type at all sites responsible for te manufacturing of te active substance as well as for te manufacturing and assembly of tis product prior to granting its national autorisation. 2/7

3 II.2 Drug Substance Te active substance ramipril is manufactured by two different external suppliers eac olding a CEP. Te active substance is controlled according to te requirements of te P. Eur. monograp and te CEPs. Stability data are provided by bot ASMs wit proposed storage conditions and re-test periods. Based on stability data provided, te proposed re-test periods and storage conditions ave been justified and accepted. II.3 Medicinal Product Te overall parmaceutical development of te drug product is based on te minimal approac to parmaceutical development cf. ICH Q8 guidance. Te development of te product is described in brief, te coice of excipients is justified and teir functions explained. Te preference of wet granulation for te manufacture of te drug product as been indicated. Validation protocols are presented. Validation data for te tablet strengts ave been presented to support te proposed batc sizes. Te drug product specifications cover appropriate parameters for tis dosage form. Te control tests and specifications for te drug product are adequately drawn up. Validations of te analytical metods are presented. Te batc analysis results demonstrate tat te drug product meets te proposed specifications and confirm consistency of te drug product. Dissolution data of te drug product ave been provided demonstrating similarity of dissolution in te entire ph range. Te conditions used in te stability studies are according to te ICH stability guideline. A justification for not providing potostability studies in accordance wit ICH as been provided. Te following self-lives/storage conditions ave been approved: 1.25 mg tablets: 18 monts/do not store above 25 C. Store in te original package in order to protect from moisture and ligt. 2.5 mg, 5 mg and 10 mg tablets: 2 years/do not store above 25 C. Store in te original package in order to protect from moisture and ligt. III. NON-CLINICAL ASPECTS III.1 Introduction Parmacodynamic, parmacokinetic and toxicological properties of ramipril are well known. As ramipril is a widely used, well-known active substance, te applicant as not provided additional studies and furter studies are not required. Overview based on literature review is, tus, appropriate. Te non-clinical overview report refers 37 publications up to year Te non-clinical overview on te pre-clinical parmacology, parmacokinetics and toxicology is adequate. III.2 Ecotoxicity/environmental risk assessment (ERA) Since Ramipril Teva is intended for generic substitution, tis will not lead to an increased exposure to te environment. An environmental risk assessment is terefore not deemed necessary. 3/7

4 IV. CLINICAL ASPECTS IV.1 Introduction Ramipril is a well-known active substance wit establised efficacy and tolerability. As ramipril is a widely used, well-known active substance, te applicant as not provided additional studies (apart from supportive bioequivalence studies referenced below) and furter studies are not required. Overview based on literature review is, tus, appropriate. Te clinical overview report refers 97 publications up to year Te clinical overview on te clinical parmacology, efficacy and safety is adequate. IV.2 Parmacokinetics To support te application, te applicant as submitted 2 bioequivalence studies. Te following study as been submitted in support of te 2.5 mg tablet strengt: Fasting study: Single-dose of 5 mg (2x2.5 mg), Delix 2.5 mg tablets, Hoecst AG, from te German market, compared to 2x2.5 mg of Ramipril Teva tablets. Te following study as been submitted in support of te 10 mg tablet strengt: Fasting study: Single-dose, Delix PROTECT 10 mg tablets, Aventis Parma Deutscland GmbH, from te German market, compared to 10 mg of Ramipril Teva tablets. Biowaiver Tablet strengt 2.5 mg is dose proportional to tablet strengt 1.25 mg wile tablet strengt 10 mg is dose proportional to tablet strengt 5 mg. Te applicant concludes bioequivalence of te oter tablet strengts 1.25 mg and 5 mg mg based on te submitted bioequivalence studies for tablet strengts 2.5 mg and 10 mg, respectively. Reference is made to Guideline on Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1). Bioequivalence studies Single-dose study of 5 mg (2x2.5 mg) Te study was an open-label, randomized, two-treatment, two-sequence, two-period, two-way crossover, single-dose bioavailability study conducted under fasting conditions wit a was out period of 28 days between te two periods. 2x2.5 mg was administered in eac period. Blood samples were collected pre-dosing and at various time-points up to 120 ours post administration of a single-dose 2x2.5 mg tablets wit 240 ml of water for te analyses of active metabolite ramiprilat. Samples up to 16 ours post administration were analysed for parent compound ramipril. 38 ealty adults (18 males/20 females), 37 Caucasians and 1 black, aged between 23 and 55 participated in te study. 38 subjects completed te study. Analytical results of 35 subjects were available for statistical and parmacokinetic analysis. Te parmacokinetic parameters calculated for ramipril and ramiprilat were:,, AUC 0- t,/,,, K el, t 1/2. Bioequivalence was based on evaluation of te 90% geometric CI T/R for -transformed, and for ramiprilat. Acceptance criteria: 80.00% to %. 4/7

5 Results Table 1. Summary statistics of parmacokinetic parameters N=35 Treatment Ramipril ng*/ml ng*/ml ng/ml ng*/ml ng*/ml Test [43.7] [45.5] [47.9] [30.8] [19.0] [27.0] Reference [45.7] [44.7] [50.5] [23.9] [20.2] [24.9] T/R Ratio 99.2% 102.4% 90.8% % 101.3% (90% CI) (94.3- (96.6- (81.3- (97.3- ( %) 108.4%) 101.5%) 102.8%) 105.8%) Area under te plasma concentration curve from administration to last observed concentration at time t. Area under te plasma concentration curve extrapolated to infinite time. does not need to be reported wen AUC 0-72 is reported instead of Maximum plasma concentration Time until is reaced Ramiprilat ng/ml [45.5] [51.0] 102.3% ( %) [34.4] [42.0] - Single-dose study of 10 mg Te study was an open-label, randomized, two-treatment, two-sequence, two-period, two-way crossover, single-dose bioavailability study conducted under fasting conditions wit a was out period of 28 days between te two periods. 1x10 mg was administered in eac period. Blood samples were collected pre-dosing and at various time-points up to 120 ours post administration of a single-dose (1x10 mg tablet) wit 240 ml of water for te analyses of active metabolite ramiprilat. Samples up to 16 ours post administration were analysed for parent compound ramipril. 38 ealty adults (32 males/6 females), 37 Caucasians and 1 black, aged between 19 and 55 were enrolled in te study. 36 subjects completed te study. Analytical results of 36 subjects were available for statistical and parmacokinetic analysis. Te parmacokinetic parameters calculated for ramipril and ramiprilat were:,, AUC 0- t,/,,, K el, t 1/2. Bioequivalence was based on evaluation of te 90% geometric CI T/R for -transformed, and for ramiprilat. Acceptance criteria: 80.00% to %. Results Table 1. Summary statistics of parmacokinetic parameters N=36 Treatment ng*/ml Test [44.2] Reference [45.4] T/R Ratio 106.0% (90% CI) ( %) ng*/ml [43.3] [44.0] 106.1% ( %) Ramipril ng/ml [60.6] [59.4] 106.0% ( %) ng*/ml [40.2] [29.4] [38.5] [26.8] % ( %) ng*/ml [29.1] [28.8] 105.2% ( %) Ramiprilat ng/ml [67.4] [60.2] 106.0% ( %) [34.8] [43.1] - 5/7

6 Area under te plasma concentration curve from administration to last observed concentration at time t. Area under te plasma concentration curve extrapolated to infinite time. does not need to be reported wen AUC 0-72 is reported instead of Maximum plasma concentration Time until is reaced Conclusion on bioequivalence studies Based on te submitted bioequivalence studies Ramipril Teva 2.5 mg and 10 mg tablets are considered bioequivalent wit Delix 2.5 mg and 10 mg tablets. Biowaivers for te additional tablet strengts ave been justified. Te RMS as been assured tat te bioequivalence study as been conducted in accordance wit acceptable standards of Good Clinical Practice (GCP, see Directive 2005/28/EC) and Good Laboratory Practice (GLP, see Directives 2004/9/EC and 2004/10/EC). IV.3 Risk management plan & Parmacovigilance system Ramipril was first approved in 1989, and tere is now more tan 10 years postautorisation experience wit te active substance. Te safety profile of ramipril can be considered to be well establised and no product specific parmacovigilance issues were identified pre- or postautorisation wic are not adequately covered by te current SPC. Additional risk minimisation activities ave not been identified for te reference medicinal product. Te MAH as a parmacovigilance system at teir disposal, wic is based on te current European legislation. Te Parmacovigilance system described fulfils te requirements and provides adequate evidence tat te applicant as te services of a qualified person responsible for parmacovigilance and as te necessary means for te identification and notification of any a potential risks occurring eiter in te Community or in a tird country. V. USER CONSULTATION A user consultation wit target patient groups on te package information leaflet (PIL) as been performed on te basis of a bridging report making reference to Ramipril ratioparm, DK/H/0543/ /MR. Te bridging report submitted by te applicant as been found acceptable. VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION Ramipril Teva 1.25 mg, 2.50 mg, 5 mg and 10 mg tablets as a proven cemical-parmaceutical quality and is a generic form of Triatec. Triatec is a well-known medicinal product wit an establised favourable efficacy and safety profile. Bioequivalence as been sown to be in compliance wit te requirements of European guidance documents. Te MAH as provided written confirmation tat systems and services are in place to ensure compliance wit teir parmacovigilance obligations. Agreement between Member States was reaced during a written procedure. Tere was no discussion in te CMD(). Te Concerned Member States, on te basis of te data submitted, considered tat essential similarity as been demonstrated for Ramipril Teva wit te reference product, and ave 6/7

7 terefore granted a marketing autorisation. Te decentralised procedure was finalised on 13 Marc Ramipril Teva was autorised in Denmark on 22 April According to te List of Union reference dates and frequency of submission of periodic safety update reports (PSURs), no PSURs are required for tis product. Te date for te first renewal will be: 13 Marc Tere were no post-approval commitments made during te procedure. 7/7

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