Nicorette QuickMist 1mg mouthspray PL 15513 …

1 UKPAR Nicorette QuickMist 1mg/spray mouthspray PL 15513 /0357 1 Nicorette QuickMist 1MG/SPRAY mouthspray PL 15513 /0357 (NICOTINE) UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 18 Steps taken after authorisation Page 19

2 Annex I Page 20 Summary of Product Characteristics Page 25 Product Information Leaflet Page 31 Labelling Page 35 UKPAR Nicorette QuickMist 1mg/spray mouthspray PL 15513 /0357 2 Nicorette QuickMist 1MG/SPRAY mouthspray PL 15513 /0357 LAY SUMMARY On 30th November 2010, the MHRA granted McNeil Products Limited a Marketing Authorisation (licence) for Nicorette QuickMist 1mg/spray mouthspray .

3 Nicorette QuickMist 1mg/spray mouthspray contains the active ingredient nicotine. Nicorette QuickMist 1mg/spray mouthspray is a nicotine replacement therapy (NRT). It is used to relieve and /or prevent withdrawal symptoms and reduce the cravings when trying to stop smoking or when cutting down on the number of cigarettes smoked. Nicorette QuickMist 1mg/spray mouthspray can be used to completely replace all your cigarettes. However Nicorette QuickMist 1mg/spray mouthspray can also be used in other ways, it can help cut down the number of cigarettes smoked, at those times when one does not want to or can t smoke - to avoid harm to others children or family.

4 - smoke free areas Pub, work, public transport aeroplanes. No new or unexpected safety concerns arose from this application and it was, therefore, judged that the benefits of taking Nicorette QuickMist 1mg/spray mouthspray outweigh the risks; hence a Marketing Authorisation has been granted. UKPAR Nicorette QuickMist 1mg/spray mouthspray PL 15513 /0357 3 Nicorette QuickMist 1MG/SPRAY mouthspray PL 15513 /0357 SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introduction Page 4 Pharmaceutical assessment Page 5 Non-clinical assessment Page 8 Clinical assessment (including statistical assessment)

5 Page 10 Overall conclusions and risk benefit assessment Page 17 UKPAR Nicorette QuickMist 1mg/spray mouthspray PL 15513 /0357 4 INTRODUCTION The UK granted a Marketing Authorisation for the medicinal product Nicorette QuickMist 1mg/spray mouthspray (PL 15513 /0357) to McNeil Products Limited on 30th November 2010. This, a General Sales List (GSL) medicine relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to: aid smokers wishing to quit or reduce prior to quitting, assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

6 This application for Nicorette QuickMist 1mg/spray mouthspray is submitted under Article of Directive 2001/83/EC as amended, as a line extension of the applicant s approved product, Nicorette Nasal Spray 10mg/ml. Nicorette Nasal Spray 10mg/ml was initially authorised to Pharmacia Laboratories Limited on 17th May 1994 (PL 00022/0141) and then underwent a change of ownership to Pharmacia Limited on 30th August 1999 (PL 00032/0255). This, in turn, underwent a change of ownership to McNeil Products Limited on 1st February 2008 (PL 15513 /0180).

7 A reclassification application to change Nicorette QuickMist 1mg/spray mouthspray from a Pharmacy (P) to General Sales List (GSL) medicine was submitted in parallel and was assessed separately to the Marketing Authorisation Application (MAA). The assessment of the reclassification can be found at the end of this report (Annex I). Nicotine is an agonist at nicotine receptors in the peripheral and central nervous system (CNS) and has pronounced CNS and cardiovascular effects. The pharmacovigilance system as described by the applicant fulfils the requirements and also provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring.

8 The Marketing Authorisation Holder (MAH) has provided a Risk Management Plan (RMP) that proposes no product specific surveillance activities beyond routine surveillance be undertaken. This is satisfactory. UKPAR Nicorette QuickMist 1mg/spray mouthspray PL 15513 /0357 5 PHARMACEUTICAL ASSESSMENT DRUG SUBSTANCE Nicotine INN: Nicotine Chemical name: 3-[(2S)-1-methylpyrrolidin-2-yl]pyridine Structure: Physical form: Colourless or brownish viscous liquid which is volatile and hygroscopic.

9 Solubility: Soluble in water and miscible with ethanol. Molecular formula: C10H14N2 Molecular weight: The source of nicotine used in the product complies with its European Pharmacopoeia monograph. The manufacturer of the drug substance holds a valid EDQM (European Directorate for the Quality of Medicines and Healthcare) Certificate of Suitability. The quality of the substance is suitably controlled in line with the current edition of the relevant European Pharmacopoeia Monograph. The manufacturing process, control of materials, control of critical steps, validation and process development for nicotine were assessed and approved by the EDQM in relation to the granting of the Certificate of Suitability and are therefore satisfactory.

10 An appropriate specification with suitable test methods and limits is provided for the drug substance. The methods of testing and limits for related substances and residual solvents are in compliance with current guidelines. Batch analysis data are provided and comply with the proposed specification. Satisfactory Certificates of Analysis have been provided for all reference standards used. The container-closure system and the re-test period comply with that which is specified on the Certificate of Suitability. DRUG PRODUCT Other ingredients Other ingredients consist of pharmaceutical excipients propylene glycol, anhydrous ethanol, trometamol, poloxamer 407, glycerol, sodium hydrogen carbonate, levomenthol, mint flavour, cooling flavour, sucralose, acesulfame potassium, hydrochloric acid and purified water.