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BUMETANIDE 0.2MG/ML ORAL SOLUTION PL 17736/0132 …

BUMETANIDE oral SOLUTION . PL 17736/0132 . 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 BUMETANIDE oral SOLUTION (PL 17736/0132 ) -1- BUMETANIDE oral SOLUTION . PL 17736/0132 . LAY SUMMARY. The MHRA granted Chemidex Pharma Limited a Marketing Authorisation (licence) for the medicinal product BUMETANIDE oral SOLUTION on 01 May 2012. This is a prescription-only medicine (POM) to treat people who have swollen feet and ankles due to fluid which has built up as a result of heart, liver or kidney disease.

MHRA PAR – Bumetanide 0.2mg/ml Oral Solution (PL 17736/0132) - 2 - BUMETANIDE 0.2MG/ML ORAL SOLUTION PL 17736/0132 LAY SUMMARY The MHRA granted Chemidex Pharma Limited a Marketing Authorisation (licence) for the

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Transcription of BUMETANIDE 0.2MG/ML ORAL SOLUTION PL 17736/0132 …

1 BUMETANIDE oral SOLUTION . PL 17736/0132 . 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 BUMETANIDE oral SOLUTION (PL 17736/0132 ) -1- BUMETANIDE oral SOLUTION . PL 17736/0132 . LAY SUMMARY. The MHRA granted Chemidex Pharma Limited a Marketing Authorisation (licence) for the medicinal product BUMETANIDE oral SOLUTION on 01 May 2012. This is a prescription-only medicine (POM) to treat people who have swollen feet and ankles due to fluid which has built up as a result of heart, liver or kidney disease.

2 It can also be used as a diuretic (water medicine) to other conditions. BUMETANIDE SOLUTION contains BUMETANIDE which is a diuretic (water medicine). It is used where there is too much water in your body. BUMETANIDE helps your kidneys produce more urine over a short period of time, which means that your body can get rid of more water quickly. This application was submitted as a duplicate of a previously granted application for BUMETANIDE Liquid oral SOLUTION , which was originally granted to Leo Laboratories Limited on 29 July 1983. After a subsequent change of ownership on 16 May 2008, the marketing authorisation holder changed to Chemidex Pharma Limited (PL.)

3 17736/0118). No new or unexpected safety concerns arose from this simple application and it was, therefore, judged that the benefits of taking BUMETANIDE oral SOLUTION outweigh the risks; hence a Marketing Authorisation has been granted. MHRA PAR BUMETANIDE oral SOLUTION (PL 17736/0132 ) -2- BUMETANIDE oral SOLUTION . PL 17736/0132 . 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 BUMETANIDE oral SOLUTION (PL 17736/0132 ) -3- INTRODUCTION. The UK granted a Marketing Authorisation for the medicinal product BUMETANIDE oral SOLUTION (PL 17736/0132 ) to Chemidex Pharma Limited on 01 May 2012.

4 This product is a prescription-only medicine (POM), indicated whenever diuretic therapy is required in the treatment of oedema, that associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome. BUMETANIDE is a loop diuretic of the sulfamyl category. The application was submitted as an simple abridged application, according to Article 10c (formerly Article (a)(i)) of Directive 2001/83/EC, cross-referring to BUMETANIDE Liquid oral SOLUTION , which was originally granted to Leo Laboratories Limited on 29 July 1983. After a subsequent change of ownership on 16 May 2008, the marketing authorisation holder changed to Chemidex Pharma Limited (PL 17736/0118).

5 No new data were submitted nor were they necessary for this simple application, as the data are identical to that of the previously granted cross-reference product. MHRA PAR BUMETANIDE oral SOLUTION (PL 17736/0132 ) -4- PHARMACEUTICAL ASSESSMENT. LICENCE NO: PL 17736/0132 . PROPRIETARY NAME: BUMETANIDE oral SOLUTION ACTIVE(S): BUMETANIDE COMPANY NAME: Chemidex Pharma Limited ARTICLE: Article 10c (formerly Article (a)(i)) of Directive 2001/83/EC. LEGAL STATUS: POM. 1. INTRODUCTION. This is a simple, piggyback application for BUMETANIDE oral SOLUTION submitted under Article 10c (formerly Article (a)(i)) of Directive 2001/83/EC. The proposed MA. holder is Chemidex Pharma Limited, T/A Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom.

6 The application cross-refers to BUMETANIDE Liquid oral SOLUTION , which was originally granted to Leo Laboratories Limited on 29 July 1983. After a subsequent change of ownership on 16 May 2008, the marketing authorisation holder changed to Chemidex Pharma Limited (PL 17736/0118). The current application is considered valid. 2. MARKETING AUTHORISATION APPLICATION FORM. Name(s). The proposed name of the product is BUMETANIDE oral SOLUTION . The product has been named in line with current requirements. Strength, pharmaceutical form, route of administration, container and pack sizes Each 1ml of product contains mg BUMETANIDE . They are to be packed in amber glass bottles, with plastic screw caps, of 5, 10, 25 and 150 ml.

7 Not all pack sizes may be marketed, but the marketing authorisation holder has committed to submitting all labelling mock-ups to the licensing authorities for approval before marketing any pack size of the product. The proposed shelf-life (3 years) and storage conditions (Store below 25 C) are consistent with the details registered for the cross-reference product. Legal status On approval, the products will be available as prescription-only medicines (POM). Marketing authorisation holder/Contact Persons/Company Chemidex Pharma Ltd, T/A Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom The QP responsible for pharmacovigilance is stated and his CV is included.

8 Manufacturers The proposed manufacturing sites are consistent with those registered for the cross-reference product and evidence of GMP compliance has been provided. MHRA PAR BUMETANIDE oral SOLUTION (PL 17736/0132 ) -5- Qualitative and quantitative composition The proposed composition is consistent with the details registered for the cross-reference product. 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 The proposed drug substance specification is consistent with the details registered for the cross-reference product. TSE Compliance No materials of animal or human origin are included in this product. This is consistent with the cross-reference 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. 4. PRODUCT NAME & APPEARANCE. See for details of the proposed product name.

10 The appearance of the product is identical to the cross-reference product. 5. SUMMARY OF PRODUCT CHARACTERISTICS (SmPC). The proposed SmPC 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 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.


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