Public Assessment Report. Scientific discussion. Rivamylan 4.6 mg /24 hours and 9.5 mg /24 hours, transdermal patches.

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1 Public Assessment Report Scientific discussion Rivamylan 4.6 mg /24 hours and 9.5 mg /24 hours, transdermal patches (rivastigmine) NL/H/2958/ /DC Date: 30 March 2015 This module reflects the scientific discussion for the approval of Rivamylan, transdermal patches 4.6 and 9.5 mg / 24 hour. The procedure was finalised at 24 October For information on changes after this date please refer to the module Update.

2 I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have granted a marketing authorisation for Rivamylan, transdermal patches 4.6 mg/24 hours and 9.5 mg/24 hours, from Mylan B.V. The product is indicated for symptomatic treatment of mild to moderately severe Alzheimer's dementia. A comprehensive description of the indications and posology is given in the SmPC. This decentralised procedure concerns a generic application claiming essential similarity with the innovator products Exelon 4.6 mg/24 hours and 9.5 mg/24 hours transdermal patches which have been registered through the centralised procedure (EMEA/H/C/169/X/38) by Novartis Europharm Ltd. since July This pharmaceutical form was authorised as a line extension to the original Exelon dossier of 1.5 mg capsules tablets which have been registered through the centralised procedure (EU/1/98/066) by Novartis Europharm Ltd. since Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones. Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer s disease and Parkinson s disease. The concerned member states (CMS) involved in this procedure were Belgium, Denmark, Finland, France, Germany, Greece, Italy, Liechtenstein, Norway, Poland, Portugal, Slovenia, Spain, Sweden, and the United Kingdom. The marketing authorisation has been granted pursuant to Article 10(1) of Directive 2001/83/EC. II. QUALITY ASPECTS II.1 Introduction Rivamylan 4.6 mg/24 hour is a transdermal patch of 5 cm 2 containing 9 mg rivastigmine, of which 4.6 mg is released over a 24 hour period. Rivamylan 9.5 mg/24 hour is a transdermal patch of 10 cm 2 containing 18 mg rivastigmine, of which 9.5 mg is released over a 24 hour period. Each round transdermal patch consists of a pigmented peach-coloured backing film randomly printed with Rivamylan 4.6 mg /24 hours or Rivamylan 9.5 mg / 24 hours in brown ink, a solid matrix drug reservoir layer, a translucent adhesive skin contact layer and a clear to slightly hazy oversized release liner that is slit and has small dimples surrounding the patch. Each patch also has a clear to slightly hazy oversized underlay. The transdermal patches are packed individually in heat-sealed child resistant sachets made of polyethylene terephthalate (PET), white low-density polyethylene (WLDPE), aluminium foil and polyacrylonitrile laminated material. The excipients are: Backing film with imprint: polyethylene/polyester film Medicinal product matrix: acrylic adhesive and poly(butylmethacrylate, methylacrylate) Adhesive matrix: dimethicone, silicone adhesive Release liner: fluoropolymer coated polyester film. II.2 Drug Substance 2/13

3 The active substance is rivastigmine, an established active substance described in the European Pharmacopoeia (Ph.Eur.). Rivastigmine is a colourless to yellow or very slightly brown coloured viscous liquid, which is miscible in water and organic solvents. A single stereoisomer (the S-isomer) is used. The rivastigmine transdermal system cannot be affected by polymorphism or particle size of the active substance, as rivastigmine in a liquid state is completely miscible and dissolved throughout the manufacturing process. The Active Substance Master File (ASMF) procedure is used for the active substance. The main objective of the ASMF procedure, commonly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or know-how of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the applicant or marketing authorisation holder (MAH) to take full responsibility for the medicinal product, the quality and quality control of the active substance. Competent Authorities/EMA thus have access to the complete information that is necessary to evaluate the suitability of the use of the active substance in the medicinal product. Manufacturing process The manufacturing process of the ASMF holder has been described. The route of synthesis is adequately characterised. Quality control of drug substance The MAH applies the same drug substance specifications as the ASMF holder, which is in line with the Ph.Eur. monograph for rivastigmine, however with two tighter limits for solvents. Description and validation have been provided for the in-house methods used. Results of batch analysis have been provided for eight production-scale batches. Stability of drug substance Stability data on the active substance have been provided in accordance with applicable European guidelines demonstrating the stability of the active substance. The drug substance was stored under accelerated and long term conditions. Based on the data submitted, a retest period could be granted of 12 months when stored at 5ºC ± 3ºC. II.3 Medicinal Product Pharmaceutical development The development of the product has been described, the choice of excipients is justified and their functions explained. Both strengths are manufactured from the same bulk laminate. With reference to use in other products, the several materials of the patch layers are not considered novel excipients. Adequate specifications have been provided for these materials. Robustness of the patch at conditions allowed according to the SmPC of the proposed and reference product (bathing, hot weather), have been substantiated with results of in-use studies. Additionally it has been demonstrated that the direction of peeling off of the release liner does not affect the peel force and does not result in an increased risk of curling or adhesion problems with the patch. The MAH chose to use an acrylic adhesive which is equivalent to the one used in the reference product, but without an anti-oxidant. The quantitative composition of the two strengths is dose-proportional. Data on the comparison of the dissolution profiles of both strengths have been provided. The drug release of the higher strength of 9.5 mg/24 hours used in the bioequivalence studies has been compared with the 4.6 mg/24 hours strength in phosphate buffer ph 6.8, 0.1N HCl and acetate buffer ph 4.5. Results were also provided of the comparison of the dissolution of the proposed products and their reference products, which were satisfactory. Manufacturing process The manufacturing process has been adequately described according to relevant European guidelines. Validation results have been provided for six pilot-scale batches, including the biobatches. As the process is a non-standard manufacturing process, only this pilot-scale is at this moment acceptable as production scale. Control of excipients 3/13

4 All the ingredients are either described in a pharmacopoeia or are purchased from an established commercial supplier, to an agreed specification, whose suitability has been established over many years of commercial supply to the pharmaceutical industry. These specifications are based on information provided by the respective suppliers and include a suitable, specific test for identification. The specifications and analytical methods are provided together with Certificates of Analysis. These specifications are acceptable. The printing ink never comes in contact with the adhesive matrix of the product and therefore does not come in contact with the skin when the patient wears the transdermal system. Quality control of drug product The drug product specification is adequately drawn up. The descriptions and validations are appropriate. Satisfactory validation data for the analytical methods have been provided. Batch analytical data for six batches from the proposed production site have been provided, demonstrating compliance with the specification. Stability of drug product Stability data have been provided on three batches of each strength stored at 25 C/60% RH (up to 24 months), 30 C/65% RH (12 months) and 40 C/75% RH (6 months). The conditions used in the stability studies are according to the ICH stability guideline. The test methods are stability indicating. A photostability study showed that the product is sensitive to light. Based on the stability data submitted, the following proposed shelf-life and storage conditions are approved: 2 years, in PET-LDPE-Al-polyacrylonitril (PAN) sachets. Do not store above 25ºC. Keep the transdermal patch in the sachet until use. Specific measures concerning the prevention of the transmission of animal spongiform encephalopathies There are no substances of ruminant animal origin present in the product nor have any been used in the manufacturing of this product, so a theoretical risk of transmitting TSE can be excluded. II.4 Discussion on chemical, pharmaceutical and biological aspects Based on the submitted dossier, the member states consider that Rivamylan, transdermal patches 4.6 mg/24 hours and 9.5 mg/ 24 hours have a proven chemical-pharmaceutical quality. Sufficient controls have been laid down for the active substance and finished product. The following post-approval commitment was made: The requirements for dissolution and cold flow will be re-evaluated when additional batch and stability results are available. III. III.1 NON-CLINICAL ASPECTS Ecotoxicity/environmental risk assessment (ERA) Since Rivamylan is intended for generic substitution, this will not lead to an increased exposure to the environment. An environmental risk assessment is therefore not deemed necessary. III.2 Discussion on the non-clinical aspects This product is a generic formulation of Exelon 4.6 mg/24 hours and 9.5 mg/24 hours transdermal patches which is available on the European market. Reference is made to the preclinical data obtained with the innovator product. A non-clinical overview on the pharmacology, pharmacokinetics and toxicology has been provided, which is based on up-to-date and adequate scientific literature. The overview justifies why there is no need to generate additional non-clinical pharmacology, pharmacokinetics and toxicology data. Therefore, the member states agreed that no further nonclinical studies are required. 4/13

5 IV. CLINICAL ASPECTS C IV.1 Introduction Rivastigmine is a well-known active substance with established efficacy and tolerability. A clinical overview has been provided, which is based on scientific literature. The overview justifies why there is no need to generate additional clinical data. Therefore, the member states agreed that no further clinical studies are required. For this generic application, the MAH has submitted six studies: a single dose and a multiple dose bioequivalence study with the 9.5mg/24h transdermal patch in healthy volunteers to compare pharmacokinetics. two reports on single dose adhesion of the test and reference transdermal patches 4.6 mg/24h and 9.5 mg/24h in healthy volunteers. two reports on comparative irritation/sensitization studies of the test and reference transdermal patches 4.6 mg/24h and 9.5 mg/24h in healthy volunteers. The studies are discussed below. IV.2 Pharmacokinetics The MAH conducted two bioequivalence studies, a single dose and a multiple dose study, in which the pharmacokinetic profile of the test product Rivamylan, transdermal patches 9.5 mg/ 24 hour (Mylan B.V., the Netherlands) is compared with the pharmacokinetic profile of the reference product Exelon 9.5 mg/24 hour transdermal patches (Novartis Europharm Ltd., Ireland) The choice of the reference product in the bioequivalence study is justified. The formula and preparation of the bioequivalence batch is identical to the formula proposed for marketing. Biowaiver A biowaiver is for the 4.6 mg/24h (9 mg/patch) transdermal patch is accepted because of the following argumentation: The qualitative composition of the two strengths is the same. The quantitative composition of the two strengths is dose-proportional. Both strengths are manufactured in the same site with the same manufacturing process. Both strengths demonstrate the same degree of local irritation, adhesiveness to the skin, phototoxicity (phototoxic potential), sensitization and similar adverse events profile compared to the reference product. There is an acceptable in vitro release test. The pharmacokinetics of rivastigmine is more than dose-proportional. Bioequivalence study I: single dose study Design A single-dose, randomised, two-period, two-treatment, crossover bioequivalence study was carried out under fasted conditions in 40 healthy male and female subjects, aged years. As secondary objectives, adhesion and irritation were also assessed. Each subject received a single 9.5 mg/24 h patch of one of the 2 rivastigmine formulations applied on clean, dry skin of the upper chest after an overnight fast of at least 10 hours. Subjects had an overlay applied over the patch at the time of application in order to test for adhesion. The patch was worn for a period of 24 hours. There were two dosing periods, separated by a washout period of a minimum of six days. Blood samples were collected at 120 minutes prior to patch application and at 2, 4, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24, 27, 30, 33 and 36 hours after application of the products. Adhesion of the patch was assessed based on a 12-point scale at the end of the dosing period. Acute dermal irritation was assessed 30 to 45 minutes following patch removal based on a scoring scale. 5/13

6 The design of the study is acceptable. The start and the duration of the sampling are sufficient to measure pharmacokinetic parameters considering the t max and half-life (10-16 h and 3-4 h, respectively) of rivastigmine. Analytical/statistical methods The analytical method has been adequately validated and is considered acceptable for analysis of the plasma samples. The methods used in this study for the pharmacokinetic calculations and statistical evaluation are considered acceptable. Results Seven subjects discontinued due to the following reasons: a greater than 15% lift of patch (3, as specified in the protocol), adverse event (2), personal reason (1) and did not report for check-in (1). The remaining 33 periods completed both periods of the study and were included in the analysis. Table 1. Pharmacokinetic parameters (non-transformed values; arithmetic mean ± SD, t max (median, range)) of rivastigmine under fasted conditions. Treatment N=33 AUC 0-t ng.h/ml AUC 0- ng.h/ml C max ng/ml t max h Test ± ± ± /13 t 1/2 h 2.3 ± 20 Reference ± ± ± ± *Ratio (90% CI) 1.07 ( ) 1.07 ( ) 1.06 ( ) - - AUC 0- area under the plasma concentration-time curve from time zero to infinity AUC 0-t area under the plasma concentration-time curve from time zero to t hours C max maximum plasma concentration t max time for maximum concentration t 1/2 half-life *ln-transformed values Conclusion The 90% confidence intervals calculated for AUC 0-t, AUC 0- and Cmax are in agreement with those calculated by the MAH and are within the bioequivalence acceptance range of Based on the pharmacokinetic parameters of rivastigmine, it can be concluded that the Rivamylan, transdermal patches 9.5 mg/ 24 hour is comparable with the pharmacokinetic profile of the reference product Exelon 9.5 mg/24 hour transdermal patches under fasted conditions with respect to rate and extent of absorption, and fulfil the bioequivalence requirements outlined in the relevant CHMP Note for Guidance. The reasons for withdrawal are acceptable, in particular, the withdrawal of the 3 subjects due to a greater than 15% lift of patch is acceptable as this was pre-defined in the protocol. It is noted that all the 3 subjects discontinued due to a greater than 15% lift of patch received the reference product. Bioequivalence study II: multiple dose study Design A multiple-dose, randomised, two-period, two-treatment, crossover bioequivalence study was carried out under steady-state conditions in 67 healthy male and female subjects, aged years. As secondary objectives, adhesion and irritation were also assessed. Each subject received three consecutive 9.5 mg/24 h patches of one of the 2 rivastigmine formulations applied on clean, dry skin of the upper chest, applied every 24 hours. Subjects had an overlay applied over the patch at the time of application in order to test for adhesion. A light breakfast was served prior to the first patch application. There were two dosing periods, separated by a washout period of a minimum of six days. Subjects were housed at least 12 hours prior to dosing until 25 hours after last patch application. Blood samples were collected on day three at 120 minutes prior to patch application and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24 hours post-dose. Adhesion of the patch was assessed based on a

7 12-point scale at the end of the dosing period. Acute dermal irritation was assessed 30 to 45 minutes following patch removal based on a scoring scale. The design of the study is acceptable. Assuming a ratio between 90%-110% and an intra-subject variability of 20%, a minimum of 37 subjects were required to conclude bioequivalence with approximately 80% power. To account for subject withdrawal and dropouts 48 subjects were originally randomized and dosed. An additional group of 20 subjects was added via protocol amendment due to an unanticipated drop-out rate in Period 1 of the study because of less than 85% adhesion throughout the rest of the study in 14 subjects. The overlay which was applied in order to ensure adhesion over the entire wear period caused irritation that precluded re-application of the overlay; therefore the overlay was not applied in the second group of subjects. Analytical/statistical methods The analytical method has been adequately validated and is considered acceptable for analysis of the plasma samples. The methods used in this study for the pharmacokinetic calculations and statistical evaluation are considered acceptable. Results Twenty-five subjects discontinued due to the following reasons: a greater than 15% lift of patch (18, as specified in the protocol), adverse event (6), and personal reasons (1). The remaining 33 subjects completed both periods of the study. Steady-state was achieved after 3 patch applications (3 days). Table 2. Pharmacokinetic parameters in steady-state (non-transformed values; arithmetic mean ± SD) Treatment AUC C max,ss C min,ss PTF% N=33 ng/ml/h ng/ml ng/ml % Test 183.1± ± ± ± 35 Reference 164.4± ± ± ± 36 *Ratio (90% CI) 1.14 ( ) 1.14 ( ) 1.15 ( ) AUC area under the plasma concentration-time curve over the dosing interval C max maximum plasma concentration C min minimum plasma concentration PTF% fluctuation index Conclusion The 90% confidence intervals calculated for AUC, Cmin,ss and Cmax,ss are within the range. Based on the pharmacokinetic parameters of rivastigmine, it can be concluded that the pharmacokinetic profile of Rivamylan, transdermal patches 9.5 mg/24 hour is comparable with that of the reference product Exelon 9.5 mg/24 hour transdermal patches under steady-state conditions with respect to rate and extent of absorption, and fulfil the bioequivalence requirements outlined in the relevant CHMP Note for Guidance. Fourteen (14) subjects were discontinued due to greater than 15% patch lift during Period 1. After a discussion about the application techniques after completion of the Group 1, Period 1 dosing, only four (4) of the additional subjects had less than 85% adhesion throughout the rest of the study. Generally, patches maintained good skin contact throughout the wear period with proper application techniques. Overall conclusion on bioequivalence studies: It has been sufficiently shown that Rivamylan 9.5 mg/24 hours transdermal patch is pharmacokinetically bioequivalent compared to the reference product Exelon Patch 9.5 mg/24 hours under both fasted and steady-state conditions. The MEB has been assured that the bioequivalence studies have been conducted in accordance with 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). 7/13

8 IV.3 Adhesion studies Two studies were performed in which the adhesion of the test product Rivamylan, transdermal patches 4.6 mg/24 hour and 9.5 mg/24 hour was compared with the adhesion of the reference product Exelon 4.6 mg/24 hour and 9.5 mg/24 hour transdermal patches (Novartis Europharm Ltd., Ireland). As a secondary objective, acute irritation was assessed. Design The two studies were irritation evaluator-blinded, randomized, single dose, one-period, two-group parallel design. Thirty-six male and female volunteers (18 years or older) were included in each study. In the first study (study I), the subjects wore one patch of the 4.6 mg/24 hour strength of the test product and one patch of the 4.6 mg/24 hour strength of the reference product simultaneously on the left and right side of the upper chest for 24 hours in a randomized fashion. In the other study (study II) either a test or a reference patch of the 9.5 mg/24 hour strength was worn for 24 hours in a randomized fashion. Adhesion assessments were performed at 4, 8, 12, 16, 20 and 24 hours (±10 minutes) after patch application by trained clinical staff utilizing a 12-point scale. A score of 100 indicated 100% adhered to the skin, while a score of 0 indicated the transdermal system was completely detached from the skin. The design of the study and the methods used are acceptable. Analytical/statistical methods The analytical method has been adequately validated and is considered acceptable for analysis of the adhesion scores. The methods used in this study for the adhesion calculations and statistical evaluation are considered acceptable. Results In studies I and II there were two and one drop-outs, respectively. Results are shown in tables 3 and 4 below. Table 3. Adhesion results study I (4.6 mg/24 hour patches) Hour Arithmetic mean (%CV) test product Arithmetic mean (%CV) reference product (2.90) (4.05) (3.89) (7.22) (2.42) (5.68) (3.29) (12.15) (6.70) (9.87) (14.05) (7.93) Cumulative mean (3.92) (6.21) Table 4. Adhesion results study II (9.5 mg/24 hour patches) Hour Arithmetic mean (%CV) test product Arithmetic mean (%CV) reference product (4.42) (3.54) (3.44) (8.12) (5.91) (6.39) (10.18) (5.58) (13.49) (8.38) (26.49) (14.36) Cumulative mean (7.95) (6.76) Conclusion The patch adhesion assessment results showed that Rivamylan transdermal patches (4.6mg/24h and 9.5mg/24 h) are non-inferior to the corresponding innovator Exelon transdermal patches with respect 8/13

9 to adhesion. However, these results should be seen in the context that the adhesion assessments of the studies were not blinded. IV.4 Local irritation and sensitization studies Two studies were performed to compare the cumulative irritation and sensitization potential of Rivamylan 4.6 mg/24 hours and 9.5 mg/24 hours with the reference product Exelon in healthy volunteers. Irritation and sensitization study I Design This was an open-label, multiple-dose, randomized application site, two-treatment, one-period human dermal safety study investigating the cumulative irritation of the test and reference product after repetitive placement of each topical patch treatment to the same skin site. Thirty-six male and female volunteers (18 years or older) were included in the study. Each subject received a 2.0 cm 2 die-cut of Rivamylan 4.6 mg/24 hours and Exelon 4.6 mg/24 hours transdermal patch applied on the right or left side of the upper chest according to the randomization scheme. Subjects wore each treatment for 24 hours. Patches were reapplied to the same skin site every 24 hours for 21 consecutive days (for a total of 21 patch applications per treatment). Patch adhesion was assessed within one hour after each patch removal by trained clinical staff. Irritation was assessed using an 8-point scale. If a subject developed an irritation score of 3 or greater, the subject did not have any further patches of that treatment applied during the study. The other treatment applications continued as scheduled. Statistical analysis The primary assessment parameter was the mean cumulative irritation, which was defined for each subject as the sum of all 21 individual irritation scores obtained at 0.5 hours after patch removal divided by 21. Subjects must have had 16 valid irritation scores recorded to be included in the analysis. For any missing score, the previous score was carried forward. The analytical method has been adequately validated and is considered acceptable for analysis of the adhesion scores. The methods used in this study for the adhesion calculations and statistical evaluation are considered acceptable. Results Four subjects were discontinued due to limiting irritation. Data from those subjects were included in the analysis as per protocol. For two subjects irritation data could not be verified, therefore the analysis was conducted with data from 34 subjects. Conclusion The statistical results of the cumulative irritation scores showed that Rivamylan transdermal patches (4.6mg/24h and 9.5mg/24 h) are non-inferior to their corresponding innovator Exelon transdermal patches, with respect to irritation. Irritation and sensitization study II Design This was an open-label, multiple-dose, randomized application site, three-treatment, three phase, oneperiod human dermal safety study investigating the cumulative irritation and contact sensitization potential of the test and reference product after repetitive placement of each topical patch treatment to the same skin site. Rivamylan 4.6 mg/24 hours was compared to two different formulations of Exelon 4.6 mg/24 hours (USA and UK). Only the results regarding the relevant, European formulation are discussed here. Two hundred and thirty-seven male and female volunteers (18 years or older) were included in the study. Each subject received a 2.0 cm 2 die-cut of Rivamylan 4.6 mg/24 hours and Exelon 4.6 mg/24 hours transdermal patch applied on the right or left side of the upper chest according to the randomization scheme. The first group of 75 subjects had an overlay applied over each treatment patch at the time of application in order to insure adhesion over the entire wear period, but because this caused irritation that precluded re-application of the overlay, the overlay was not applied in the remaining subjects. 9/13

10 Subjects wore each treatment for 24 hours. Patches were reapplied to the same skin site every 24 hours for 21 consecutive days (for a total of 21 patch applications per treatment), followed by a 14-day rest phase and a subsequent 48-hour challenge phase, followed by a 3-day observation and irritation evaluation. In the event that a subject was potentially sensitized, the challenge phase was repeated during a re-challenge phase between 4 to 8 weeks after the conclusion of the challenge phase. Only the sites that had sensitization reactions were re-challenged. Patch adhesion was assessed within one hour after each patch removal by trained clinical staff. Irritation was assessed using an 8-point scale. If a subject developed an irritation score of 3 or greater, the subject did not have any further patches of that treatment applied during the study. The other treatment application continued as scheduled. If a subject developed an irritation score of 3 or greater, the subject did not have any further patches applied to the same application site during the induction phase of the study. In this case, any reapplications for induction were made at a designated alternate site and appropriately documented and diagrammed. All other treatment applications continued as scheduled. During the induction phase, irritation assessments were performed 30 to 45 minutes after each patch was removed. During the challenge phase, irritation assessments occurred at study hours 0.5, 24, 48, and 72 hours after removal of the patch. Patch adhesion was assessed within one hour prior to patch removal during the induction and challenge phases. Subjects remained at the clinical site until completion of all scheduled study procedures at a given time, but were then allowed to leave and return as needed. Interpretation of a potential sensitization reaction was based on combined dermal response/other effects score of at least 2 at the last challenge phase evaluation and was generally a higher score than what was observed in the induction phase. This reaction is distinguished from an irritation reaction, which would be anticipated to subside after patch removal. Statistical analysis The primary assessment parameter was the mean cumulative irritation, which was defined for each subject as the sum of all 21 individual irritation scores obtained at 0.5 hours after patch removal divided by 21. Subjects must have had 16 valid irritation scores recorded to be included in the analysis. For any missing score, the previous score was carried forward. The analytical method has been adequately validated and is considered acceptable for analysis of the adhesion scores. The methods used in this study for the adhesion calculations and statistical evaluation are considered acceptable. Results Thirty-one subjects dropped out of the study for the following reasons: adverse event (6), protocol deviations (8), withdrawal of consent (17). 206 subjects completed the study for at least one treatment. For both the test and reference products, 15 subjects had sensitization scores that would indicate a sensitization reaction. For Rivamylan 19 subjects were potentially considered sensitized after the challenge phase, 18 subjects returned for the re-challenge Phase, 14 were confirmed to have sensitization and four 4 were deemed not to be sensitizers; one (1) subject was not re-challenged. For the Exelon patch 18 subjects were potentially considered sensitized after the challenge phase, 15 subjects returned for the re- challenge phase, 13 were confirmed to have sensitization, and 2 were deemed not to be sensitizers; 3 subjects were not re-challenged. The results of the sensitization scores showed that Rivamylan transdermal patches 9.5mg/24 h are comparable to Exelon transdermal patches 9.5mg/24 h (sensitized subjects: 7% and 6.5%, respectively) with respect to sensitization. Safety No new safety issues were identified. Except for the last study the safety profile of the two products in all the other studies appeared to be comparable. Conclusion The statistical results of the cumulative irritation scores showed that Rivamylan transdermal patches (4.6mg/24h and 9.5mg/24 h) are non-inferior to their corresponding innovator Exelon transdermal patches, with respect to irritation and sensitization. 10/13

11 IV.5 Risk Management Plan C 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 Rivamylan transdermal patches 4.6mg/24h and 9.5mg/24 h. - Summary of Safety Concerns and Planned Risk Minimisation Activities as approved in RMP Important identified risks Important potential risks Important missing information Gastrointestinal symptoms (nausea, vomiting and diarrhoea) Worsening of motor symptoms associated with Parkinson s disease Pancreatitis Cardiac arrhythmias Exacerbation of asthma and COPD Application site skin reactions and irritations Hypertension Gastrointestinal ulceration, haemorrhage and perforation Seizures Hallucinations Syncope and loss of consciousness Medication misuse Medication errors Dehydration Liver disorders Severe skin reactions (bullous reactions) Myocardial infarction Cerebrovascular accident Pulmonary infections Death Acute renal failure none The MAH should follow, where appropriate, the risk minimization activities of the innovator. The MAH committed to submit educational material, the final version of which should be agreed by the National Competent Authorities of each member state, before marketing. IV.6 Discussion on the clinical aspects For this authorisation, reference is made to the clinical studies and experience with the innovator product Exelon transdermal patches. No new clinical studies were conducted. The MAH demonstrated through studies that the pharmacokinetic profile of the product is similar to the pharmacokinetic profile of this reference product, and that adhesion, irritation, and sensitization are non-inferior. Risk management is adequately addressed. This generic medicinal product can be used instead of the reference product. V. USER CONSULTATION A user consultation with target patient groups on the package leaflet (PL) has been performed on the basis of a bridging report making reference to the PL of the centrally authorised reference product Exelon transdermal patches. Furthermore, the layout and design of the Rivastigmine PL is in line with the house style of the MAH: reference is made to user tests of other products to confirm that the leaflet design allows information to be easily located by the user. The bridging report has been found acceptable. 11/13

12 VI. C OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION Rivamylan, transdermal patches 4.6 and 9.5 mg/ 24 hour has a proven chemical-pharmaceutical quality and is a generic form of Exelon 4.6 and 9.5 mg/24 hour transdermal patches. Exelon 4.6 and 9.5 mg/24 hour transdermal patches are a well-known medicinal products with an established favourable efficacy and safety profile. Bioequivalence has been shown to be in compliance with the requirements of European guidance documents. Non-inferiority to the innovator has been demonstrated for adhesion, irritation, and sensitization in a number of studies. The Board followed the advice of the assessors. There was no discussion in the CMD(h). Agreement between member states was reached during a written procedure. The member states, on the basis of the data submitted, considered that essential similarity has been demonstrated for Rivamylan, transdermal patches 4.6 and 9.5 mg/ 24 hour with the reference product, and have therefore granted a marketing authorisation. The decentralised procedure was finalised with a positive outcome on 24 October /13

13 STEPS TAKEN AFTER THE FINALISATION OF THE INITIAL PROCEDURE - SUMMARY Scope Procedure number Type of modification Date of start of the procedure Date of end of the procedure Approval/ non approval Assessment report attached 13/13

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