covonia chesty cough sugar free syrup - … chesty cough sugar free syrup is identical to the...

UKPAR Covonia Chesty Cough Sugar Free Syrup PL 12063/0124

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Covonia Chesty Cough Sugar Free Syrup

(Guaifenesin)

PL 12063/0124

UKPAR

TABLE OF CONTENTS Lay Summary

Page 2

Scientific discussion

Page 4

Steps taken for assessment

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Summary of Product Characteristics

Page 13

Patient Information Leaflet

Page 14

Labelling

Page 15


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LAY SUMMARY

Covonia Chesty Cough Sugar Free Syrup (Guaifenesin)

This is a summary of the Public Assessment Report (PAR) for Covonia Chesty Cough Sugar Free Syrup (PL 12063/0124). It explains how Covonia Chesty Cough Sugar Free Syrup was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use Covonia Chesty Cough Sugar Free Syrup. For practical information about using Covonia Chesty Cough Sugar Free Syrup, patients should read the package leaflet or contact their doctor or pharmacist. What is Covonia Chesty Cough Sugar Free Syrup and what is it used for? Covonia Chesty Cough Sugar Free Syrup contains the active substance guaifenesin. This medicine is used to loosen stubborn mucus (phlegm) and provide relief from chesty coughs. Covonia Chesty Cough Sugar Free Syrup is a duplicate of a previously granted application, Expectorant Cough Syrup (PL 12063/0021), which is also held by the applicant (Wrafton Laboratories Limited) and authorised on 7th March 1997. How is Covonia Chesty Cough Sugar Free Syrup used? Covonia Chesty Cough Sugar Free Syrup is taken by mouth. Covonia Chesty Cough Sugar Free Syrup is on the General Sale List (GSL) and is available from pharmacies and other outlets without prescription. The recommended dose in adults, the elderly and children 12 years and over is 15 ml. Each dose should be taken as required, but the dose should not be repeated more frequently than every 6 hours. Not more than 3 doses should be taken in any period of 24 hours. This medicine should not be given to children under the age of 12 years. How does Covonia Chesty Cough Sugar Free Syrup work? Covonia Chesty Cough Sugar Free Syrup contains guaifenesin, which is an expectorant to help loosen phlegm. Such expectorants are known to increase the volume of secretions in the respiratory tract and facilitate their removal by cilary action and coughing. How has Covonia Chesty Cough Sugar Free Syrup been studied? Covonia Chesty Cough Sugar Free Syrup is identical to the previously granted application for Expectorant Cough Syrup (PL 12063/0021; Wrafton Laboratories Limited). The company (Wrafton Laboratories Limited) has referred to their own data held for the grant of a licence for Expectorant Cough Syrup (PL 12063/0021) as the basis for the grant of a licence for Covonia Chesty Cough Sugar Free Syrup (PL 12063/0124).


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What are the benefits and risks of Covonia Chesty Cough Sugar Free Syrup? As Covonia Chesty Cough Sugar Free Syrup is considered identical to Expectorant Cough Syrup (PL 12063/0021), its benefits and risks are taken as being the same as those for Expectorant Cough Syrup (PL 12063/0021). Why is Covonia Chesty Cough Sugar Free Syrup approved? No new or unexpected safety concerns arose from this application. It was, therefore, considered that the benefits of Covonia Chesty Cough Sugar Free Syrup outweigh the risks, and the grant of a Marketing Authorisation was recommended. What measures are being taken to ensure the safe and effective use of Covonia Chesty Cough Sugar Free Syrup? A risk management plan has been developed to ensure that Covonia Chesty Cough Sugar Free Syrup is used as safely as possible. Based on this plan, safety information has been included in the Summary of Product Characteristics and the package leaflet for Covonia Chesty Cough Sugar Free Syrup, including the appropriate precautions to be followed by healthcare professionals and patients. Other information about Covonia Chesty Cough Sugar Free Syrup A Marketing Authorisation was granted in the UK on 29th May 2014. For more information about taking Covonia Chesty Cough Sugar Free Syrup, read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in July 2014. The full PAR for Covonia Chesty Cough Sugar Free Syrup follows this summary.


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(Guaifenesin)

PL 12063/0124

SCIENTIFIC DISCUSSION

TABLE OF CONTENTS Introduction

Page 5

Pharmaceutical assessment

Page 6

Non-clinical assessment

Page 9

Clinical assessment

Page 10

Overall conclusion and benefit-risk assessment Page 11


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INTRODUCTION

The Medicines and Healthcare products Regulatory Agency (MHRA) granted Wrafton Laboratories Limited a Marketing Authorisation for the medicinal product Covonia Chesty Cough Sugar Free Syrup (PL 12063/0124) on 29th May 2014. The product is on the General Sale List (GSL) and is available from pharmacies and other outlets without prescription. This medicine is used to loosen stubborn mucus and clear chesty coughs. This application was submitted as a simple application according to Article 10c of Directive 2001/83/EC, as amended. The applicant has cross-referred to Expectorant Cough Syrup (PL 12063/0021), which is held by the applicant and authorised on 7th March 1997. Covonia Chesty Cough Sugar Free Syrup contains the active ingredient guaifenesin. Guaifenesin is a well-known expectorant. Such expectorants are known to increase the volume of secretions in the respiratory tract and therefore to facilitate their removal by cilary action and coughing. No new data were submitted nor were they necessary for this simple application, as the data are identical to those of the previously granted cross-reference product. The MHRA has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place for these product types at all sites responsible for the manufacture and assembly of this product. .


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PHARMACEUTICAL ASSESSMENT

LICENCE NO: PL 12063/0124 PROPRIETARY NAME: Covonia Chesty Cough Sugar Free Syrup ACTIVE: Guaifenesin COMPANY NAME: Wrafton Laboratories Limited E.C. ARTICLE: Article 10c of Directive 2001/83/EC, as amended LEGAL STATUS: GSL 1 INTRODUCTION This is an informed consent application for Covonia Chesty Cough Sugar Free Syrup, submitted under Article 10c of Directive 2001/83/EC, as amended. The applicant has cross-referred to Expectorant Cough Syrup (PL 12063/0021), which is held by the applicant and authorised on 7th March 1997. The current application is considered valid. 2 MARKETING AUTHORISATION APPLICATION (MAA) 2.1 Name(s) The proposed name of the product is Covonia Chesty Cough Sugar Free Syrup. The product has been named in line with current requirements. 2.2 Strength, pharmaceutical form, route of administration, container and pack sizes This product is a syrup for oral use and contains 200 mg guaifenesin per 15 ml dose. The syrup is taken by mouth. The finished product is packed in amber glass bottles with polypropylene/polythene caps containing 150 ml of the product. Satisfactory specifications and Certificates of Analysis for all packaging components used have been provided. The packaging and pack size are the same as those for the cross-reference product. The proposed shelf-life is 3 years with a storage condition “Do not store above 25˚C”. The shelf-life and storage condition are identical to those for the cross-reference product and are satisfactory. 2.3 Legal status Covonia Chesty Cough Sugar Free Syrup will be available as a General Sale List (GSL) medicine. 2.4 Marketing Authorisation Holder/Contact Persons/Company The proposed Marketing Authorisation Holder is Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL The Qualified Person (QP) responsible for pharmacovigilance is stated and a satisfactory CV has been provided.


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2.5 Manufacturers The proposed manufacturing sites are consistent with those registered for the cross-reference product and evidence of Good Manufacturing Practice (GMP) compliance has been provided. 2.6 Qualitative and quantitative composition The proposed composition is consistent with the details registered for the cross-reference product. 2.7 Manufacturing process The proposed manufacturing process is consistent with the details registered for the cross-reference product and the maximum full scale batch size is stated. 2.8 Finished product specifications The proposed finished product specification is in line with the details registered for the cross-reference product. 2.9 Drug substance specification The proposed drug substance specification conforms to the current European Pharmacopoeia monograph for guaifenesin and is in line with that for the cross-reference product. A European Directorate for the Quality of Medicines and Healthcare (EDQM) Certificate of Suitability for the manufacture of guaifenesin has been provided. The active substance manufacturers are the same as those for the cross-reference product. 2.10 TSE Compliance No materials of animal or human origin are included in this product. This is consistent with the cross-reference product. 2.11 Bioequivalence No bioequivalence data are required to support this informed consent application, as the proposed product is manufactured to the same formula utilising the same process as the cross-reference product, Expectorant Cough Syrup (PL 12063/0021). 3 EXPERT REPORTS The applicant has cross-referred to the data for the cross-reference product, Expectorant Cough Syrup (PL 12063/0021), to which it claims to be identical. This is acceptable. The applicant has included detailed expert reports of the application. Signed declarations and copies of the experts’ CVs are enclosed 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 name. The appearance of the product is identical to that of the cross-reference product.


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5. SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) The proposed SmPC is consistent with the details registered for the cross-reference product. 6. PATIENT INFORMATION LEAFLET (PIL)/LABELLING The package leaflet is identical to the leaflet for the reference product. The proposed artwork complies with the relevant statutory requirements. In line with current legislation the applicant has also included the name of the product in Braille on the outer packaging and sufficient space for a standard UK pharmacy dispensing label. 7. CONCLUSION The data submitted with the application are acceptable. The grant of a Marketing Authorisation is recommended.


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NON-CLINICAL ASSESSMENT

No new non-clinical data have been supplied with this application and none are required for applications of this type. A satisfactory justification has been provided for not submitting the Environmental Risk Assessment (ERA).


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CLINICAL ASSESSMENT

No new clinical data have been supplied with this application and none are required for applications of this type. A summary of the pharmacovigilance system and detailed Risk Management Plan have been provided with this application. These are satisfactory.


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OVERALL CONCLUSION AND BENEFIT-RISK ASSESSMENT QUALITY The data for this application are consistent with those previously assessed 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. CLINICAL This application is identical to the previously granted application for Expectorant Cough Syrup (PL 12063/0021), which is held by the applicant and authorised on 7th March 1997. No new or unexpected safety concerns arose from this application. PRODUCT LITERATURE The SmPC, PIL and labelling are satisfactory and consistent with those for the cross-reference product. BENEFIT RISK ASSESSMENT The quality of the product is acceptable and no new non-clinical or clinical concerns have been identified. The applicant’s product is identical to the cross-reference product. Extensive clinical experience with guaifenesin is considered to have demonstrated the therapeutic value of the compound. The benefit-risk is, therefore, considered to be positive.


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(Guaifenesin)

PL 12063/0124

STEPS TAKEN FOR ASSESSMENT

1 The MHRA received the Marketing Authorisation application on 26th November

2012

2 Following standard checks and communication with the applicant the MHRA considered the application valid on 29th November 2012

3 Following assessment of the application the MHRA requested further information on the dossier on 28th January 2013, 15th April 2013 and 18th November 2013

4 The applicant responded to the MHRA’s request, providing further information on 8th March 2013, 10th July 2013 and 18th December 2013

5 The application was determined on 29th May 2014


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SUMMARY OF PRODUCT CHARACTERISTICS

In accordance with Directive 2010/84/EU the Summaries of Product Characteristics (SmPCs) for products that have been granted Marketing Authorisations at a national level are available on the MHRA website.


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PATIENT INFORMATION LEAFLET

In accordance with Directive 2010/84/EU the Patient Information Leaflets (PILs) for products that have been granted Marketing Authorisations at a national level are available on the MHRA website.


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LABELLING


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covonia chesty cough sugar free syrup - … chesty cough sugar free syrup is identical to the...

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