mhl mpl benzocaine sore throat spray 1.5mg … · mhl/mpl benzocaine sore throat spray 1.5 mg...

MHL/MPL BENZOCAINE SORE THROAT SPRAY 1.5 MG OROMUCOSAL SPRAY

PL 15833/0059-60

UKPAR

TABLE OF CONTENTS Lay Summary

Page 2

Scientific discussion

Page 3

Steps taken for assessment

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Steps taken after authorisation – summary

Page 12

Summary of Product Characteristics

Page 13

Product Information Leaflet

Page 13

Labelling

Page 14

UKPAR MHL/MPL Benzocaine Sore Throat Spray 1.5 mg Oromucosal Spray PL 15833/0059-60

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MHL/MPL BENZOCAINE SORE THROAT SPRAY 1.5 MG

OROMUCOSAL SPRAY

PL 15833/0059-60

LAY SUMMARY On 10th October 2012, the MHRA granted Manx Pharma Limited Marketing Authorisations (licences) for MHL/MPL Benzocaine Sore Throat Spray 1.5 mg Oromucosal Spray. MHL/MPL Benzocaine Sore Throat Spray 1.5 mg Oromucosal Spray contains the active ingredient benzocaine, which is a local anaesthetic. Local anaesthetics relieve pain by acting on the surface area treated. The spray is used to relieve the pain of sore throats and minor mouth infections. No new or unexpected safety concerns arose from these applications and it was, therefore, judged that the benefits of taking MHL/MPL Benzocaine Sore Throat Spray 1.5 mg Oromucosal Spray outweigh the risks; hence these Marketing Authorisations have been granted.


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OROMUCOSAL SPRAY

PL 15833/0059-60

SCIENTIFIC DISCUSSION

TABLE OF CONTENTS Introduction

Page 4

Pharmaceutical assessment

Page 5

Non-clinical assessment

Page 8

Clinical assessment (including statistical assessment)

Page 9

Overall conclusions and risk benefit assessment

Page 10


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INTRODUCTION

The MHRA granted Marketing Authorisations for the medicinal products MHL/MPL Benzocaine Sore Throat Spray 1.5 mg Oromucosal Spray (PL 15833/0059-60) to Manx Pharma Limited on 10th October 2012. These medicines are available in pharmacies (P) and are indicated for the symptomatic temporary relief of pain associated with sore throat pain and minor mouth infections. These applications for MHL/MPL Benzocaine Sore Throat Spray 1.5 mg Oromucosal Spray are submitted according to Article 10c (informed consent application) of Directive 2001/83/EC, as amended, cross-referring to AAA Mouth and Throat Spray, originally licensed to CSL Behring UK Limited on 20th March 1991 (PL 00231/5026R). This licence underwent changes of ownership to May and Baker Limited on 20th March 1996 (PL 00012/0295) and Manx Pharma Limited on 1st September 1997 (PL 15833/0001). It is considered that the pharmacovigilance system as described by the applicant fulfils the requirements and provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance together with the necessary means for notification of any adverse reaction suspected of occurring. A Risk Management Plan was not submitted or required for these generic applications. No new data were submitted nor were they necessary for these “informed consent” applications, as the data are identical to that of the previously granted cross-reference products.


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PHARMACEUTICAL ASSESSMENT

LICENCE NO: PL 15833/0059-60 PROPRIETARY NAME: MHL/MPL Benzocaine Sore Throat Spray 1.5 mg Oromucosal

Spray ACTIVE(S): Benzocaine COMPANY NAME: Manx Pharma Limited E.C. ARTICLE: Article 10c of Directive 2001/83/EC, as amended LEGAL STATUS: P 1. INTRODUCTION These are “informed consent” applications for MHL/MPL Benzocaine Sore Throat Spray 1.5 mg Oromucosal Spray (PL 15833/0059-60) submitted under Article 10c of Directive 2001/83/EC, as amended. The proposed Marketing Authorisation Holder (MAH) is Manx Pharma Limited, Taylor Group House, Wedgnock Lane, Warwick, CV34 5YA, United Kingdom. These applications cross-refer to AAA Mouth and Throat Spray, originally licensed to CSL Behring UK Limited on 20th March 1991 (PL 00231/5026R). This licence underwent changes of ownership to May and Baker Limited on 20th March 1996 (PL 00012/0295) and Manx Pharma Limited on 1st September 1997 (PL 15833/0001). 2. MARKETING AUTHORISATION APPLICATION FORM 2.1 NAME(S) The proposed names of the products are MHL/MPL Benzocaine Sore Throat Spray 1.5 mg Oromucosal Spray. 2.2 Strength, pharmaceutical form, route of administration, container and pack sizes The products are oromucosal sprays that contain 1.5 mg of benzocaine. The products are administered by topical application to the mucosa of the mouth and throat by means of a metered dose aerosol. The products are packaged in white aluminium spray containers with metering pump and high density polyethylene cap, and polypropylene and nitrilic rubber nozzle. The pack size is one spray container holding not less than 7.3 g (approximately 60 metered doses). The shelf-life of the products is 24 months with storage conditions ‘Do not store above 25°C.’ The shelf-life is consistent with the details registered for the cross-reference product. The storage conditions are consistent with an already approved similar product, licensed to the same MAH, Manx Benzocaine Sore Throat Spray 1.5 mg Oromucosal Spray (PL 15833/0013). This is satisfactory. 2.3 Legal status Pharmacy (P). 2.4 Marketing authorisation holder/Contact Persons/Company Manx Pharma Limited, Taylor Group House, Wedgnock Lane, Warwick, CV34 5YA, United Kingdom.


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The QP responsible for pharmacovigilance is stated and their CV is included. 2.5 Manufacturers The manufacturing sites are consistent with those registered for the cross-reference product and evidence of GMP compliance has been provided. 2.6 Qualitative and quantitative composition The composition is consistent with the details registered for the cross-reference product. 2.7 Manufacturing process The manufacturing process is consistent with the details registered for the cross-reference product. 2.8 Finished product/shelf-life specifications The finished product specifications are in-line with the details registered for the cross-reference product. 2.9 Drug substance specification The drug substance specification is consistent with the details registered for the cross-reference product. 2.10 TSE Compliance None of the excipients used contain material of animal or human origin. This information is consistent with the cross-reference product. 3. EXPERT REPORTS Quality, non-clinical and clinical expert statements have been provided in Module 2 of the application. Signed declarations and copies of the experts’ CVs are enclosed in Module 1.4 for the quality, non-clinical and clinical experts. All are considered to have sufficient experience for their responsibilities. 4. PRODUCT NAME & APPEARANCE See 2.1 for details of the proposed product names. The appearance of the products is identical to the cross-reference product. 5. SUMMARY OF PRODUCT CHARACTERISTICS (SmPCs) The SmPCs are consistent with the details registered for the cross-reference product. 6. PATIENT INFORMATION LEAFLETS (PILs)/LABELLING PILs A satisfactory bridging report has been provided. The PIL readability has cross-referred to the reference product PIL readability, which is acceptable since the content, layout, formatting and appearance of the test leaflet are identical to that of the reference PIL.


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Labelling The artwork is comparable to the artwork registered for the cross-reference product and complies with statutory requirements. 7. CONCLUSIONS The data submitted with the application are acceptable. The grant of these Marketing Authorisations is recommended.


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NON-CLINICAL ASSESSMENT

No new non-clinical data have been supplied with these applications and none are required for applications of this type. A satisfactory justification has been provided for the absence of an Environmental Risk Assessment.


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CLINICAL ASSESSMENT

No new clinical data have been supplied with these applications and none are required for applications of this type.


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OVERALL CONCLUSION AND RISK BENEFIT ASSESSMENT

QUALITY The data for these applications are consistent with those previously approved for the cross-reference product and, as such, have been judged to be satisfactory. NON-CLINICAL No new non-clinical data were submitted and none are required for applications of this type. EFFICACY These applications are considered a duplicate of the previously granted application, AAA Mouth and Throat Spray, originally licensed to CSL Behring UK Limited on 20th March 1991 (PL 00231/5026R). This licence underwent changes of ownership to May and Baker Limited on 20th March 1996 (PL 00012/0295) and Manx Pharma Limited on 1st September 1997 (PL 15833/0001). No new or unexpected safety concerns arise from these applications. At the time of assessment, the SmPCs, PILs and labelling are satisfactory and consistent with that for the cross-reference product. RISK BENEFIT ASSESSMENT The quality of the products is acceptable and no new non-clinical or clinical safety concerns have been identified. The applicant’s products are identical to the cross-reference product. Extensive clinical experience with benzocaine is considered to have demonstrated the therapeutic value of the compound. The risk:benefit is, therefore, considered to be positive.


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OROMUCOSAL SPRAY

PL 15833/0059-60

STEPS TAKEN FOR ASSESMENT

1 The MHRA received the Marketing Authorisation Application on 10th January 2012.

2 Following standard checks and communication with the applicant the MHRA considered the application valid on 20th April 2012.

3 Following assessment of the application further information was requested regarding the quality section of the dossier on 14th June 2012 and 31st August 2012.

4 The applicant responded to the MHRA’s requests, providing further information on 15th August 2012 and 4th September 2012 for the quality section.

5 The application was determined on 10th October 2012.


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OROMUCOSAL SPRAY

PL 15833/0059-60

STEPS TAKEN AFTER ASSESSMENT

Date submitted

Application type

Scope Outcome


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SUMMARY OF PRODUCT CHARACTERISTICS AND PATIENT INFORMATION LEAFLET

In accordance with Directive 2010/84/EU the Summaries of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) for products granted Marketing Authorisations at a national level are available on the MHRA website.


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LABELLING


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mhl mpl benzocaine sore throat spray 1.5mg … · mhl/mpl benzocaine sore throat spray 1.5 mg...

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