FLUCONAZOLE 150 MG CAPSULE PL 36390/0029 …

1 UKPAR FLUCONAZOLE 150 mg CAPSULE PL 36390/0029 FLUCONAZOLE 150 MG CAPSULE PL 36390/0029 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Steps taken after authorisation summary Page 12 Summary of Product Characteristics Product Information Leaflet Labelling Page 13 Page 21 Page 23 UKPAR FLUCONAZOLE 150 mg CAPSULE PL 36390/0029 2 FLUCONAZOLE 150 MG CAPSULE PL 36390/0029 LAY SUMMARY On 10th February 2012, the MHRA granted STD Chemicals Limited a Marketing Authorisation (licence) for FLUCONAZOLE 150 mg CAPSULE .

2 FLUCONAZOLE 150 mg CAPSULE contains the active ingredient, FLUCONAZOLE . FLUCONAZOLE belongs to a group of medicines called anti-fungals which are used to treat infections caused by fungi (including yeasts such as one called Candida). Single FLUCONAZOLE 150mg capsules may be used for the treatment of vaginal thrush in women (vaginal candidiasis) and thrush infections of the skin around the tip of the penis (candidal balanitis) in men (including under the foreskin in uncircumcised men). These infections are due to a yeast that is called Candida. The single 150 mg dose treatment is suitable only for treating these specific infections in men and women. It is not enough to treat other infections caused by fungi (yeasts and moulds).

3 No new or unexpected safety concerns arose from this application and it was, therefore, judged that the benefits of taking FLUCONAZOLE 150 mg CAPSULE outweigh the risks; hence a Marketing Authorisation has been granted. UKPAR FLUCONAZOLE 150 mg CAPSULE PL 36390/0029 3 FLUCONAZOLE 150 MG CAPSULE PL 36390/0029 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 UKPAR FLUCONAZOLE 150 mg CAPSULE PL 36390/0029 4 INTRODUCTION The MHRA granted a Marketing Authorisation for the medicinal product FLUCONAZOLE 150 mg CAPSULE (PL 36390/0029 )

4 To STD Chemicals Limited on 10th February 2012. This medicine is supplied through pharmacies only (P) and is indicated for the treatment of: Vaginal candidiasis, acute or recurrent. Candidal balanitis associated with vaginal candidiasis. This application for FLUCONAZOLE 150 mg CAPSULE is submitted according to Article 10c of Directive 2001/83/EC, cross-referring to FLUCONAZOLE 150 CAPSULE , originally authorised to Neolab Limited on 13th February 2008 (PL 08137/0120). This licence underwent a change of ownership to Fannin (UK) Limited on 8th August 2011 (PL 20417/0044). 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.

5 A Risk Management Plan (RMP) was not provided and is not required for an application of this type. No new data were submitted nor were they necessary for this informed consent application, as the data are identical to that of the previously granted cross-reference product. UKPAR FLUCONAZOLE 150 mg CAPSULE PL 36390/0029 5 PHARMACEUTICAL ASSESSMENT LICENCE NO: PL 36390/0029 PROPRIETARY NAME: FLUCONAZOLE 150 mg CAPSULE ACTIVE(S): FLUCONAZOLE COMPANY NAME: STD Chemicals Limited ARTICLE: Article 10c of Directive 2001/83/EC LEGAL STATUS: P 1. INTRODUCTION This is an informed consent application for FLUCONAZOLE 150 mg CAPSULE (PL 36390/0029 ) submitted under Article 10c of Directive 2001/83/EC.

6 The proposed Marketing Authorisation Holder (MAH) is STD Chemicals Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW. This application cross-refers to FLUCONAZOLE 150 CAPSULE , originally authorised to Neolab Limited on 13th February 2008 (PL 08137/0120). This licence underwent a change of ownership to Fannin (UK) Limited on 8th August 2011 (PL 20417/0044). 2. MARKETING AUTHORISATION APPLICATION FORM NAME(S) The proposed name of the product is FLUCONAZOLE 150 mg CAPSULE . The product has been named in-line with current requirements. Strength, pharmaceutical form, route of administration, container and pack sizes The product contains 150 mg of FLUCONAZOLE as the active ingredient in a CAPSULE administered orally.

7 The finished product is packaged in blister strips comprised of 25 micron aluminium foil with 250 micron white opaque polyvinyl chloride (PVC) film coated with 60 gsm polyvinylidene chloride (PVdC). The product comes in a single pack size of 1 CAPSULE . The proposed shelf-life is 24 months with storage conditions Do not store above 25oC and Store in the original package This is consistent with the details registered for the cross-reference product. Legal status Supplied through pharmacies only (P). Marketing authorisation holder/Contact Persons/Company STD Chemicals Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW. The QP responsible for pharmacovigilance is stated and his CV is included.

8 Manufacturers The 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 composition is consistent with the details registered for the cross-reference product. UKPAR FLUCONAZOLE 150 mg CAPSULE PL 36390/0029 Manufacturing process The 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 finished product specification is in-line with the details registered for the cross-reference product.

9 Drug substance specification The drug substance specification complies with the European Pharmacopoeia monograph for FLUCONAZOLE . TSE Compliance The excipients used are identical to those in the cross-reference products and declarations have been provided to confirm that none contain material of human origin. Valid EDQM (European Directorate for the Quality of Medicines and Healthcare) Certificates of Suitability for TSE has been provided for gelatin, which is of animal origin. Declarations from the supplier and applicant have confirmed that the sodium lauryl sulphate used in this product is of vegetable origin. The milk used in the production of the lactose is sourced from healthy animals under the same conditions as those intended for human consumption.

10 This information is consistent with the cross-reference product. 3. EXPERT REPORTS The applicant has included the quality expert report (for the reference product, which is identical) and non-clinical and clinical expert statements in Module 2 of the applications. 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. The appearance of the product is identical to the cross-reference product. 5. SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) The SmPC is consistent with the details registered for the cross-reference product.