Glyceryl Trinitrate Spray PL 16431 0023-UKPAR - GOV.UK

1 MHRA- UKPAR - Glyceryl Trinitrate Spray 400 g per metered dose sublingual Spray - PL 16431 /0023. Glyceryl Trinitrate Spray 400 MICROGRAMS PER METERED. DOSE SUBLINGUAL Spray . PL 16431 /0023. 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. Patient Information Leaflet Page 17. Labelling Page 18. -1- MHRA- UKPAR - Glyceryl Trinitrate Spray 400 g per metered dose sublingual Spray - PL 16431 /0023. Glyceryl Trinitrate Spray 400 MICROGRAMS PER METERED. DOSE SUBLINGUAL Spray . PL 16431 /0023. LAY SUMMARY. The MHRA granted Ayrton Saunders Limited a Marketing Authorisation for the medicinal product Glyceryl Trinitrate Spray 400 micrograms per metered dose sublingual Spray (PL.)

2 16431 /0023) on 11th September 2007. This pharmacy-only medicine (P) is used for rapid relief from an angina attack, and can also be used to prevent an anticipated attack. The active ingredient, Glyceryl Trinitrate , acts by relaxing the muscle walls of the blood vessels and reduces the workload of the heart. This application is identical to a previously granted application for Glyceryl Trinitrate Spray 400 micrograms per metered dose sublingual Spray (PL 16431 /0019) granted to the same Marketing Authorisation Holder on 21st November 2002. The original product was granted to Bioglan Laboratories Limited (PL 00041/0021) on the 14th June 1991. No new or unexpected safety concerns arose from this simple application and it was, therefore, judged that the benefits of taking Glyceryl Trinitrate Spray 400 micrograms per metered dose sublingual Spray outweigh the risks; hence a Marketing Authorisation has been granted.

3 -2- MHRA- UKPAR - Glyceryl Trinitrate Spray 400 g per metered dose sublingual Spray - PL 16431 /0023. Glyceryl Trinitrate Spray 400 MICROGRAMS PER METERED. DOSE SUBLINGUAL Spray . PL 16431 /0023. SCIENTIFIC DISCUSSION. TABLE OF CONTENTS. Introduction Page 4. Pharmaceutical assessment Page 5. Preclinical assessment Page 7. Clinical assessment Page 8. Overall conclusions and risk benefit assessment Page 9. -3- MHRA- UKPAR - Glyceryl Trinitrate Spray 400 g per metered dose sublingual Spray - PL 16431 /0023. INTRODUCTION. The UK granted a marketing authorisation for the medicinal product Glyceryl Trinitrate Spray 400 micrograms per metered dose sublingual Spray (PL 16431 /0023) to Ayrton Saunders Limited on 11th September 2007.

4 The product is a pharmacy-only medicine. The application was submitted as a simple abridged application according to Article 10c of Directive 2001/83/EC, cross -referring to Glyceryl Trinitrate Spray 400 micrograms per metered dose sublingual Spray (PL 16431 /0019) approved on 21st November 2002. No new data were submitted nor was it necessary for this simple application, as the data are identical to that of the previously granted cross -reference product. As the cross -reference product was granted prior to the introduction of current legislation, no Public Assessment Report (PAR) has been generated for it. The product contains the active ingredient Glyceryl Trinitrate which acts on vascular smooth muscles to produce arterial and venous vasodilatation.

5 The vasodilatation results in a reduction of venous return and an improvement in myocardial perfusion with the result of a reduction in the work performed by the heart and hence reduced oxygen demand. -4- MHRA- UKPAR - Glyceryl Trinitrate Spray 400 g per metered dose sublingual Spray - PL 16431 /0023. PHARMACEUTICAL ASSESSMENT. LICENCE NO: PL 16431 /0023. PROPRIETARY NAME: Glyceryl Trinitrate Spray 400 mircograms per metered dose sublingual Spray ACTIVE(S): Glyceryl Trinitrate COMPANY NAME: Ayrton Saunders Limited ARTICLE: Article 10c (formerly Article (a)(i)) of Directive 2001/83/EC. LEGAL STATUS: P. 1. INTRODUCTION. This is a simple, informed consent application for Glyceryl Trinitrate Spray 400.

6 Micrograms per metered dose sublingual Spray submitted under Article 10c (formerly Article (a)(i)) of Directive 2001/83/EC. The proposed MA holder is Ayrton Saunders Limited, Peninsular Business Park, Reeds Lane, Moreton, Wirral, Merseyside, CH46 1DW, UK. The application cross -refers to Glyceryl Trinitrate Spray 400 micrograms per metered dose sublingual Spray (PL 16431 /0019), approved on 21st November 2002 to the same marketing authorisation holder. The current application is considered valid. 2. MARKETING AUTHORISATION APPLICATION FORM. Name(s). The proposed name of the product is Glyceryl Trinitrate Spray 400 mircograms per metered dose sublingual Spray . The product has been named in line with current requirements.

7 Strength, pharmaceutical form, route of administration, container and pack sizes The product contains Glyceryl Trinitrate equivalent to 400 g per metered dose. It is to be stored in a pressurised aluminium container fitted with a metered valve. The proposed shelf-life (24 months) and storage conditions ( Store below 25oC. Do not refrigerate or freeze. Do not expose to temperatures higher than 50oC. Do not pierce the canister ) are consistent with the details registered for the cross -reference product. Legal status On approval, the products will not be subject to a medical prescription, but will be supplied through pharmacies only. Marketing authorisation holder/Contact Persons/Company Peninsular Business Park, Reeds Lane, Moreton, Wirral, Merseyside, CH46 1DW, UK.

8 The QP responsible for pharmacovigilance is stated and his CV is included. Manufacturers The proposed manufacturing sites are consistent with those registered for the cross - reference product and evidence of GMP compliance has been provided. Qualitative and quantitative composition The proposed composition is consistent with the details registered for the cross -reference product. -5- MHRA- UKPAR - Glyceryl Trinitrate Spray 400 g per metered dose sublingual Spray - PL 16431 /0023. Manufacturing process The proposed manufacturing process is consistent with the details registered for the cross - reference product 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 product.

9 Drug substance specification There are differences between the proposed drug substance specification and the drug substance specification registered for the cross -reference product. Specifications for inorganic ions and GTN assay are broader than the limits registered for the cross reference product (but comply with the drug substance monograph). TSE Compliance There are no materials of animal origin 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. All are considered to have sufficient experience for their responsibilities.

10 4. PRODUCT NAME & APPEARANCE. See for details of the proposed product name. The appearance of the product is identical to the cross -reference product. 5. SUMMARY OF PRODUCT CHARACTERISTICS. The proposed summary is consistent with the details registered for the cross -reference product. 6. PATIENT INFORMATION LEAFLET/CARTON. PIL. The patient information leaflet has been prepared in-line with the details registered for the cross -reference product. Carton 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.