Public Assessment Report. Scientific discussion

Transcription

1 Public Assessment Report Scientific discussion 1) Risedronat Actavis 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten 2) Bifodron 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten 3) Risedronat Swan Pond 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten 4) Risedronat SPI 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten 5) Risedronat Gentian 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten 6) Risemed 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten 7) Risetab 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten 8) Risedronat Medis 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten 9) Porisor 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten 10) Riselam 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten Active Substance: Risedronate sodium 1/20

2 AT/H/ /01-03/DC This module reflects the scientific discussion for the approval of Risedronat Actavis 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten, Bifodron 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten, Risedronat Swan Pond 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten, Risedronat SPI 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten, Risedronat Gentian 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten, Risemed 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten, Risetab 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten Risedronat Medis 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten, Porisor 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten, Riselam 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten (in the following named: Risedronat 5 mg, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten,)The procedure was finalised at /20

3 I. INTRODUCTION General comments on the submitted dossier: Actavis Group PTC ehf., Hafnarfjördur, Iceland, Swan Pond Investments, Edinburgh, United Kingdom, Gentian Generics Limited, Liverpool, United Kingdom, and Medis ehf., Hafnarfjördur, Iceland have applied for a marketing authorisation for Risedronate 5 mg film-coated tablets / 30 mg film-coated tablets and 35 mg (once weekly) film-coated tablets under different names (Risedronat Actavis (1), Bifodron (2), Risedronat Swan Pond (3), Risedronat SPI (4), Risedronat Gentian (5), Risemed (6), Risetab (7), Risedronat Medis (8), Porisor (9), Riselam (10)). With AT as the Reference Member State (RMS) in this Decentralised Procedure, they applied for marketing authorisations in: AT (Austria), BG (Bulgaria), CY (Cyprus), CZ (Czech Republic), DK (Denmark), EE (Estonia), EL (Greece), ES (Spain), FI (Finland), HU (Hungary), IE (Ireland), IS (Iceland), LT (Lithuania), LV (Latvia), MT (Malta), NO (Norway), PL (Poland), PT (Portugal) and SI (Slovenia) The application is submitted based on article 10(1) as a generic application. Exception: AT/H/0235/02/DC in CMS HU is an abridged application, according to article 10(3), a so called hybrid application as the reference product in HU is of a different strength (5mg instead of 30mg). The original product is Actonel 5mg and Actonel 30mg film-coated tablets by Procter & Gamble Pharmaceuticals UK Ltd., Ireland. Essential similarity with the European brand leader Actonel 5 mg and 35mg tablet is claimed based on two bioequivalence studies. A biowaiver for the 30mg strength is claimed by the applicant. The BE studies were carried out in accordance with the Note for Guidance on the Investigation of Bioavailability and Bioequivalence (CPMP/EWP/QWP/1401/98). The submitted dossier is of adequate quality. The products are not intended for use in children and adolescents, and safety and efficacy of risedronate sodium have not been established in this population. About the product: 3/20

4 Risedronate is a pyridinyl bisphophonate that has an affinity for hydroxyapatite crystals in the bone and inhibits osteoclast-mediated bone resorption. Bone turnover is reduced whereas osteoblast activity and bone mineralisation are maintained. Pharmacotherapeutic group: Bisphosphonates, ATC Code: M05B A07 Proposed indications: Risedronate 5mg film-coated tablets: Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures. Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis. To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months) systemic corticosteroid treatment at doses 7.5mg/day prednisone or equivalent. Risedronate 30mg film-coated tablets: Treatment of Paget s disease of the bone. Risedronate 35mg film-coated tablets: Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures. Treatment of osteoporosis in men at high risk of fractures. Proposed posology and method of administration: The absorption of risedronate sodium is affected by food. Thus, to ensure adequate absorption patients should take risedronate before breakfast, at least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. The tablets must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach risedronat is to be taken while in an upright position with a glass of plain water ( 120 ml). Patients should not lie down for 30 minutes after taking the tablet. Risedronate 5mg film-coated tablets: The recommended daily dose for adults is one 5mg tablet orally. 4/20

5 In the particular instance that before breakfast dosing is not practical, Risedronate 5mg can be taken between meals or in the evening at the same time every day, with strict adherence to the following instructions, to ensure that it is taken on an empty stomach: Between meals: Risedronate 5mg should be taken at least 2 hours before and at least 2 hours after any food, medicinal product or drink (other than plain water). In the evening: Risedronate 5mg should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day, and at least 30 minutes before going to bed. If an occasional dose is missed, risedronate can be taken before breakfast, between meals, or in the evening according to the instructions above. Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate. Risedronate 30mg film-coated tablets: The recommended daily dose for adults is one 30mg tablet orally for 2 months. If retreatment is considered necessary (at least two months post-treatment), a new treatment with the same dose and duration of therapy could be given. In the particular instant that before breakfast dosing is not practical, Risedronate 30mg can be taken between meals or in the evening at the same time every day, with strict adherence to the following instructions: Between meals: Risedronate 30mg should be taken at least 2 hours before and at least 2 hours after any food, medicinal product or drink (other than plain water). In the evening: Risedronate 30mg should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day, and at least 30 minutes before going to bed. If an occasional dose is missed, Risedronate can be taken before breakfast, between meals, or in the evening according to the instructions above. Physicians should consider the administration of supplemental calcium and vitamin D if the dietary intake is inadequate, especially as bone turnover is significantly elevated in Paget s disease. Risedronate 35mg film-coated tablets: The recommended dose in adults is one 35mg tablet orally once a week. The tablet should be taken on the same day each week. Patients should be instructed that if a dose is missed, one Risedronate 35mg tablet should be taken on the day that the tablet is remembered. Patients should then return 5/20

6 Contraindications to taking one tablet once a week on the day the tablet is normally taken. Two tablets should not be taken on the same day. Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate. Hypersensitivity to the active substance or to any of the excipients. Hypocalcaemia (see section 4.4). Pregnancy and breast-feeding. Severe renal impairment (creatinine clearance < 30 ml/min). General comments on compliance with GMP, GLP, GCP and agreed ethical principles. The RMS has been assured that acceptable standards of GMP are in place for these product types at all sites responsible for the manufacture and assembly of these products. For the (amorphous) API manufacturer (Brazil), certificates regarding the GMP-conforming manufacture of the active substance based on internal audits were presented by the Qualified Persons of the drug product manufacturing and batch releasing company Actavis, Iceland. For the manufacturing site within the Community (Iceland), the RMS has accepted copies of current manufacturer authorisations issued in 2007 by inspection services of the competent authorities as certification that acceptable standards of GMP are in place at this site. Compliance with GCP and GLP is confirmed in the Study Reports and in the Analytical Reports, respectively. The study protocols and informed consent forms were approved by an institutional review board. The CRO Algorithme Pharma Inc. was recently inspected by Austrian Inspectors, no negative findings were reported. Concerning a planned Austrian inspection of the CRO MDS Pharma Services (clinical part), based on information by EMA, there was no need for an inspection as it was recently inspected by another competent authority. Concerning Warnex Bioanalytical Services (analytical part), this site was inspected on the 17 th and 18 th of November The Inspection Report, dated 11 th of February 2010, confirms that the study AA71843 is regarded to be reliable and trustworthy. II. QUALITY ASPECTS II.1 Introduction Risedronat 5 mg, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten is a Film-coated tablet which is presented in Al/PVC blister packs and tablet containers (HDPE). 6/20

7 II.2 Drug Substance The active substance in Risedronat 5 mg, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten is risedronate sodium. The specification of the active substance meets the current scientific requirements. The adequate quality of the active substance has been shown by submitting the appropriate control data. The stability of the active substance has been tested under ICH conditions. The results of the stability studies support the established retest-period. II.3 Medicinal Product Risedronat 5 mg, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten contains the following excipients: Each 5 mg film coated tablet contains mg lactose monohydrate. Each 30 mg film coated tablet contains mg lactose monohydrate. Each 35 mg film coated tablet contains mg lactose monohydrate. Tablet core: Magnesium stearate Crospovidone Lactose monohydrate Microcrystalline cellulose Film coating: Hypromellose Colloidal silica, anhydrous Hydroxypropylcellulose Macrogol 400 Macrogol 8000 Titanium dioxide (E171) Iron oxide yellow (E172) (only 5mg tablet and 35 mg tablet) Iron oxide red (E172) (only 35 mg tablet) The manufacturers responsible for batch release are: The development of the product has been sufficiently made and deemed appropriate. The usage of all the excipients has been described. The release specification includes the check of all parameters relevant to this pharmaceutical form. Appropriate data concerning the control of the finished product support the compliance with the release specifications. The packaging of the medicinal product complies with the current legal requirements. Stability studies under ICH conditions have been performed and data presented support the shelf life claimed in the SmPC, with a shelf life of 36 (no special storage conditions required). The pharmaceutical quality of Risedronat 5 mg, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten has been adequately shown. 7/20

8 II.4 Discussion on chemical, pharmaceutical and biological aspects III. NON-CLINICAL ASPECTS Pharmacodynamic, pharmacokinetic and toxicological properties of risedronate are well known. As risedronate is a widely used, well-known active substance, the applicant has not provided additional studies and further studies are not required. Overview based on literature review is, thus, appropriate. For generic applications of this nature, the need for repetitive tests on animals and humans is avoided. Reference is made to the reference medicinal product Actonel 5mg and Actonel 30mg film-coated tablets by Procter & Gamble Pharmaceuticals UK Ltd., Ireland. IV. CLINICAL ASPECTS IV.1 Introduction Risedronate is a bisphophonate indicated on one hand for the prevention and treatment of osteoporosis and on the other hand (30 mg only) for the treatment of Morbus Paget s disease of the bone. In order to show essential similarity with the brand leader Actonel 5mg, 30mg and 35mg tablets, by Procter&Gamble Pharmaceuticals (SE/H/0192), the applicant carried out two single-dose bioequivalence studies with the 5mg and 35mg dosage strengths under fasting conditions. For the 30mg strength a biowaiver was claimed by the applicant. IV.2 Pharmacokinetics The pharmacokinetics of risedronate has been well established by the innovator. The applicant has provided two Bioavailability-Bioequivalence studies, comparing the kinetics of the formulations, which are discussed in the Clinical Assessment Report. IV.3 Pharmacodynamics The pharmacodynamic profile of risedronate in man has been well established by the innovator. No additional data has been submitted. IV.4 Clinical efficacy The indications claimed are in accordance with those of the innovator product Actonel. The efficacy of risedronate is established and documented in controlled clinical studies. No additional data has been submitted. IV.5 Clinical safety Literature of long-term studies in humans was provided in the Clinical Overview. Risedronate showed a satisfactory tolerability profile in post-marketing surveillance. Based on the European PSUR Work Sharing Core Safety Profile from July 20 th 2009 of risedronate sodium (SE/H/PSUR/0008/003), some additional information concerning clinical 8/20

9 safety was added. The wording has been taken into consideration in the assessment of the SmPC and PL. IV.6 Discussion on the clinical aspects In order to show essential similarity with the brand leader Actonel 5mg, 30mg and 35mg tablets, by Procter&Gamble Pharmaceuticals, the applicant carried out two single-dose bioequivalence studies with the 5mg and 35mg dosage strengths under fasting conditions. For the 30mg strength a biowaiver was claimed by the applicant. For the conclusion of bioequivalence the standard acceptance range of 0.8 to 1.25 was chosen for the primary criterion AUC0-t. The primary parameter Cmax was to be within the 75 to 133 % acceptance range. This widening of the interval was prospectively justified, taking into account the large variability of risedronate (inhouse intra-subject variation up to 52%). Another criterion was the fact that risedronate is well-tolerated in humans. Study RST-P6-278 was a randomised, laboratory-blinded, four-period, two-sequence, crossover, single dose, replicate, comparative bioavailability study of Risedronate sodium 5mg tablets in healthy male and female subjects. The test to reference ratio of geometric LS-means and the corresponding 90 % CI for Cmax were within the predefined acceptance interval of 75 to 133 % and also between the standard acceptance range of 80 to 125 %. For AUC0-t and AUC0- the test to reference ratios of geometric LS-means and the corresponding 90 % confidence intervals were also within the acceptance range of %. Bioequivalence has been shown appropriately. Study AA71843 was a randomised, laboratory-blinded, two-period, two-sequence, cross-over, single-dose, comparative bioavailability study of Risedronate sodium 35mg tablets in healthy male and female subjects. The test to reference ratio of geometric LS-means and the corresponding 90 % CI for Cmax were within the predefined acceptance interval of 75 to 133 %. For AUC0-t and AUC0- the relative ratios were also within %. The 90% CI of the relative geometric LS-means for AUC0- slightly exceeded the upper limit of the acceptance range (127 %). However, AUC0- was not an endpoint in this study. Bioequivalence has been shown appropriately. The results of study AA71843 with the 35mg formulation were extrapolated to the 30mg strength according to conditions in Note for Guidance on the Investigation of Bioavailability and Bioequivalence CPMP/EWP/QWP/1401/98, section 5.4. Hence a biowaiver can be granted. V. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION 9/20

10 The pharmaceutical quality of Risedronat 5 mg, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten has been adequately shown. The dossier and the bioequivalence studies are in compliance with CHMP guidance documents. The efficacy of risedronate is established and documented in controlled clinical studies. Risedronate has an acceptable adverse event profile. The SmPCs were brought in line with the brand leader SmPCs for Actonel (SE/H/0192). The applicant updated the SmPCs with respect to comments made by RMS and CMSs and taking into consideration the new SmPC-guideline and the most recent QRD-template. 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 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 PLs were brought in line with the updated SmPCs. The introduced amendments are considered to improve the overall safety of the PL and would not invalidate conclusions on the user-test. Based on the submitted bioequivalence study (RST-P6-278) Risedronate 5mg film-coated tablet is considered to be bioequivalent with the reference product. The benefit risk assessment is found to be positive and approval for the 5mg strength is recommended. Based on the submitted bioequivalence study (AA71843) Risedronate 35mg film-coated tablet is considered to be bioequivalent with the reference product. The benefit risk assessment is found to be positive and approval for the 35mg strength is recommended. The results of the study with the 35mg formulation could be extrapolated to the 30mg strength according to conditions in Note for Guidance on the Investigation of Bioavailability and Bioequivalence CPMP/EWP/QWP/1401/98, section 5.4. Hence a biowaiver can be granted. ANNEX Labelling PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING Carton and label of 5 mg film-coated tablets in tablet containers and carton for Al/PVC blisters 10/20

11 1. NAME OF THE MEDICINAL PRODUCT / / 5 mg film-coated tablets risedronate sodium 2. STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of risedronate sodium (equivalent to 4.64 mg risedronic acid). 3. LIST OF EXCIPIENTS Contains lactose. See leaflet for further information. 4. PHARMACEUTICAL FORM AND CONTENTS Blisters: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets Tablet containers: 30 film-coated tablets 100 film-coated tablets 5. METHOD AND ROUTE(S) OF ADMINISTRATION Oral use Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 11/20

12 8. EXPIRY DATE EXP: 9. SPECIAL STORAGE CONDITIONS 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER {Name and Address} <{tel}> <{fax}> <{ }> 12. MARKETING AUTHORISATION NUMBER(S) 13. BATCH NUMBER Lot: 14. GENERAL CLASSIFICATION FOR SUPPLY 15. INSTRUCTIONS ON USE 16. INFORMATION IN BRAILLE /.../ 5 mg 12/20

13 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 7 or 14 count Al/PVC blisters for 5 mg film-coated tablets 1. NAME OF THE MEDICINAL PRODUCT / / 5 mg film-coated tablets risedronate sodium 2. NAME OF THE MARKETING AUTHORISATION HOLDER {Name} 3. EXPIRY DATE EXP: 4. BATCH NUMBER Lot: 5. OTHER MON TUE WED THU FRI SAT SUN 13/20

14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING Carton and label of 30 mg film-coated tablets in tablet containers and carton for Al/PVC blisters 1. NAME OF THE MEDICINAL PRODUCT / / 30 mg film-coated tablets risedronate sodium 2. STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of risedronate sodium (equivalent to mg risedronic acid). 3. LIST OF EXCIPIENTS Contains lactose. See leaflet for further information. 4. PHARMACEUTICAL FORM AND CONTENTS Blisters: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets Tablet containers: 30 film-coated tablets 100 film-coated tablets 5. METHOD AND ROUTE(S) OF ADMINISTRATION Oral use Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 14/20

15 8. EXPIRY DATE EXP: 9. SPECIAL STORAGE CONDITIONS 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER {Name and Address} <{tel}> <{fax}> <{ }> 12. MARKETING AUTHORISATION NUMBER(S) 13. BATCH NUMBER Lot: 14. GENERAL CLASSIFICATION FOR SUPPLY 15. INSTRUCTIONS ON USE 16. INFORMATION IN BRAILLE /.../ 30 mg 15/20

16 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 7 or 14 count Al/PVC blisters for 30 mg film-coated tablets 1. NAME OF THE MEDICINAL PRODUCT / / 30 mg film-coated tablets risedronate sodium 2. NAME OF THE MARKETING AUTHORISATION HOLDER {Name} 3. EXPIRY DATE EXP: 4. BATCH NUMBER Lot: 5. OTHER MON TUE WED THU FRI SAT SUN 16/20

17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING Carton and label of 35 mg film-coated tablets in tablet containers and carton for Al/PVC blisters 1. NAME OF THE MEDICINAL PRODUCT / / 35 mg film-coated tablets risedronate sodium 2. STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 35 mg of risedronate sodium (equivalent to mg risedronic acid). 3. LIST OF EXCIPIENTS Contains lactose. See leaflet for further information. 4. PHARMACEUTICAL FORM AND CONTENTS Blisters: 2 film-coated tablets 4 film-coated tabelts 8 film-coated tablets 12 film-coated tabelts Tablet containers: 4 film-coated tablets 12 film-coated tablets 5. METHOD AND ROUTE(S) OF ADMINISTRATION Oral use Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 17/20

18 8. EXPIRY DATE EXP: 9. SPECIAL STORAGE CONDITIONS 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER {Name and Address} <{tel}> <{fax}> <{ }> 12. MARKETING AUTHORISATION NUMBER(S) 13. BATCH NUMBER Lot: 14. GENERAL CLASSIFICATION FOR SUPPLY 15. INSTRUCTIONS ON USE The dose is one tablet a week. Check here the choosen day. MON TUE WED THU FRI 18/20

19 SAT SUN 16. INFORMATION IN BRAILLE /.../ 35 mg 19/20

20 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Al/PVC blisters for 35 mg film-coated tablets 1. NAME OF THE MEDICINAL PRODUCT / / 35 mg film-coated tablets risedronate sodium 2. NAME OF THE MARKETING AUTHORISATION HOLDER {Name} 3. EXPIRY DATE EXP: 4. BATCH NUMBER Lot: 5. OTHER 20/20