Dispersible Aspirin 75mg Tablets BP PL 17907 0155-6

1 Dispersible Aspirin 75mg Tablets BP. PL 17907 / 0155-6 . UKPAR. TABLE OF CONTENTS. Lay Summary Page 2. Scientific discussion Page 3. Steps taken for assessment Page 10. Steps taken after authorisation summary Page 11. Summary of Product Characteristics Page 12. Product Information Leaflet Page 27. Labelling Page 29. MHRA PAR Dispersible Aspirin 75mg Tablets BP (PL 17907 / 0155-6 ) -1- Dispersible Aspirin 75mg Tablets BP. PL 17907 / 0155-6 . LAY SUMMARY. The MHRA granted Bristol Laboratories Limited Marketing Authorisations (licences) for the medicinal product Dispersible Aspirin 75mg Tablets BP (PL 17907 / 0155-6 ) on 10th February 2006. These pharmacy-only (P PL 17907 /0155) and prescription-only medicines (POM PL 17907 /0156) are for the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following by-pass surgery. Dispersible Aspirin 75mg Tablets BP contains the active ingredient Aspirin (salicylic acid).

2 Which acts as an anticoagulant/anti-thrombotic agent. These applications are duplicates of a previously granted application, Dispersible Aspirin 75mg Tablets (PL 00211/0005), which was initially granted a licence in June 1982. No new or unexpected safety concerns arose from these simple applications and it was, therefore, judged that the benefits of taking Dispersible Aspirin 75mg Tablets BP outweigh the risks, hence, Marketing Authorisations have been granted. MHRA PAR Dispersible Aspirin 75mg Tablets BP (PL 17907 / 0155-6 ) -2- Dispersible Aspirin 75mg Tablets BP. PL 17907 / 0155-6 . SCIENTIFIC DISCUSSION. TABLE OF CONTENTS. Introduction Page 4. Pharmaceutical assessment Page 5. Preclinical assessment Page 8. Clinical assessment Page 9. Overall conclusions and risk benefit assessment Page 10. MHRA PAR Dispersible Aspirin 75mg Tablets BP (PL 17907 / 0155-6 ) -3- INTRODUCTION. The UK granted marketing authorisations for the medicinal products Dispersible Aspirin 75mg Tablets BP (PL 17907 / 0155-6 ) to Bristol Laboratories Limited on 10th February 2006.

3 The products are pharmacy-only (P PL 17907 /0155) and prescription-only medicines (POM PL 17907 /0156). The applications were submitted as simple abridged applications according to Article 10c (formerly (a)(i)) of Directive 2001/83/EC, cross-referring to Dispersible Aspirin 75mg Tablets (PL 00211/0005), which was initially granted a licence in June 1982. No new data was submitted nor was it necessary for these simple applications, as the data is identical to that of the previously granted cross-reference product. As the cross-reference products were granted prior to the introduction of current legislation, no PARs were generated for them. The products contain the active ingredient Aspirin , which acts as an anticoagulant/anti- thrombotic agent. Dispersible Aspirin 75mg Tablets BP are indicated for the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following by-pass surgery.

4 MHRA PAR Dispersible Aspirin 75mg Tablets BP (PL 17907 / 0155-6 ) -4- PHARMACEUTICAL ASSESSMENT. LICENCE NO: PL 17907 / 0155-6 . PROPRIETARY NAME: Dispersible Aspirin 75mg Tablets BP. ACTIVE(S): Aspirin COMPANY NAME: Bristol Laboratories Limited ARTICLE: Article 10c (formerly (a)(i)) of Directive 2001/83/EC. LEGAL STATUS: POM. 1. INTRODUCTION. This is a simple, piggy back application for Dispersible Aspirin 75mg Tablets BP. submitted under Article 10c (formerly (a)(i)) of Directive 2001/83/EC. The proposed MA holder is Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamstead, HP4 1EG, UK. These applications cross refer to standard abridged applications for Dispersible Aspirin 75mg Tablets (PL 00211/0005), which is currently registered in the UK. These applications are considered valid. 2. MARKETING AUTHORISATION APPLICATION FORM. Name(s). The proposed names of the products are Dispersible Aspirin 75mg Tablets BP.

5 The products have been named in line with current requirements. Strength, pharmaceutical form, route of administration, container and pack sizes The products contain Aspirin , equivalent to 75mg . They are to be stored in blister packs (PVC film base with paper/aluminium foil lid) contained in cardboard cartons and in polypropylene/polyethylene child-resistant containers. For the pharmacy only product (PL 17907 /0155), blister packs contain 12, 20, 24, 28, 30, 32, 48, 56, 60, 84, 96, 98 or 100 Tablets and child-resistant containers 32, 50 or 100 Tablets . For the prescription only product (PL 17907 /0156), blister packs contain 112 Tablets and child-resistant containers 500 or 1,000 Tablets . The proposed shelf-life of 2 years is consistent with the cross-reference product. The storage conditions for the blister packs are Do not store above 25oC. Store in the original package and for the polypropylene/polyethylene containers are Do not store above 25oC.

6 Keep the container tightly closed . These are consistent with the cross-reference product. Legal status On approval, the products will be subject to either sale in a pharmacy only (P: PL. 17907 /0155) or a medical prescription by healthcare professionals only (POM: PL. 17907 /0156). Marketing authorisation holder/Contact Persons/Company The proposed Marketing Authorisation holder is Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamstead, HP4 1EG, UK. The QP responsible for pharmacovigilance is stated and their CV is included. MHRA PAR Dispersible Aspirin 75mg Tablets BP (PL 17907 / 0155-6 ) -5- Manufacturers The proposed manufacturing sites are consistent with those registered for the cross- reference products and evidence of GMP compliance has been provided. Qualitative and quantitative composition The proposed compositions are consistent with the details registered for the cross-reference products.

7 Manufacturing process The proposed manufacturing process is consistent with the details registered for the cross- reference products and the maximum batch size is stated. Finished product/shelf-life specification The proposed finished product specification is in line with the details registered for the cross-reference products. Drug substance specification The proposed drug substance specification for each product is consistent with the details registered for the cross-reference products. TSE Compliance A European Pharmacopoeia Certificate of Suitability has been provided for lactose monohydrate. No other materials of animal or human origin are included in the product. 3. EXPERT REPORTS. The applicant has included detailed expert reports in Module 2 of the application. Signed declarations and copies of the experts' CVs are enclosed in Module for the quality, non- clinical and clinical experts.

8 All are considered to have sufficient experience for their responsibilities. 4. PRODUCT NAME & APPEARANCE. See for details of the proposed product names. The appearances of the products are identical to the cross-reference products. 5. SUMMARY OF PRODUCT CHARACTERISTICS. The proposed SmPCs are consistent with the details registered for the cross-reference products. 6. PATIENT INFORMATION LEAFLET/CARTON. PIL. The patient information leaflet has been prepared in-line with the details registered for the cross-reference products. Carton and blister The proposed artwork is comparable to the artwork registered for the cross-reference product and complies with statutory requirements. In line with current legislation the applicant has also included the name of the product in Braille on the outer packaging and has included sufficient space for a standard UK pharmacy dispensing label.

9 MHRA PAR Dispersible Aspirin 75mg Tablets BP (PL 17907 / 0155-6 ) -6- 7. CONCLUSIONS. The data submitted with the applications are acceptable. Marketing Authorisations should be granted. MHRA PAR Dispersible Aspirin 75mg Tablets BP (PL 17907 / 0155-6 ) -7- PRECLINICAL ASSESSMENT. No new preclinical data have been supplied with these applications and none are required for an application of this type. MHRA PAR Dispersible Aspirin 75mg Tablets BP (PL 17907 / 0155-6 ) -8- CLINICAL ASSESSMENT. As these are duplicate applications to Dispersible Aspirin 75mg Tablets (PL 00211/0005), no new clinical data have been supplied and none are required. MHRA PAR Dispersible Aspirin 75mg Tablets BP (PL 17907 / 0155-6 ) -9- OVERALL CONCLUSION AND RISK BENEFIT ASSESSMENT. QUALITY. The data for these applications is consistent with that previously assessed for the cross- reference product and as such has been judged to be satisfactory.

10 PRECLINICAL. No new preclinical data were submitted and none are required for applications of this type. EFFICACY. Aspirin is a well known drug and has been used as an antithrombotic agent for many years. These applications are identical to a previously granted application for Dispersible Aspirin 75mg Tablets (PL 00211/0005). No new or unexpected safety concerns arise from these applications. The SPC, PIL and labelling are satisfactory and consistent with that for the cross-reference product. RISK BENEFIT ASSESSMENT. The quality of the product is acceptable and no new preclinical or clinical safety concerns have been identified. The applicant's products are identical to the cross-reference products. Extensive clinical experience with Aspirin is considered to have demonstrated the therapeutic value of the compound. The risk benefit is therefore considered to be positive. MHRA PAR Dispersible Aspirin 75mg Tablets BP (PL 17907 / 0155-6 ) - 10 - Dispersible Aspirin 75mg Tablets BP.