29831 Con266117
User Manual: 29831
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Aciclovir 200mg Tablets Aciclovir 400mg Tablets Aciclovir 800mg Tablets PL 29831/0517 PL 29831/0518 PL 29831/0519 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/Label MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) Page 13 Page 14 -1- Aciclovir 200mg Tablets Aciclovir 400mg Tablets Aciclovir 800mg Tablets PL 29831/0517-9 LAY SUMMARY The Medicine and Healthcare Regulatory Agency (MHRA) granted Wockhardt UK Limited Marketing Authorisations (licences) for the medicinal products Aciclovir 200mg, 400mg and 800mg Tablets on 25 February 2013. These are prescription-only medicines (POM). Aciclovir 200mg, 400mg and 800mg Tablets can be used to: treat herpes and other viral infections caused by the herpes virus (varicella zoster), such as shingles prevent recurrent attacks of herpes simplex help prevent those who have low immune systems from getting herpes infections. Aciclovir Tablets should not be used to treat herpes simplex virus (HSV) infections in newborns and babies up to 3 months old or severe HSV infections in children with low resistance to disease. Aciclovir belongs to a group of medicines called antivirals. These applications are duplicates of previously granted applications for Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0001-3), which were authorised to the Marketing Authorisation Holder Wockhardt UK Limited on 18 January 2007. Acilovir 200mg, 400mg and 800mg Tablets (PL 29831/0001-3), were originally granted Marketing Authorisations (PL 04543/0392-4) to CD Pharmaceuticals Limited on 29 June1999. On 18 January 2007, the Marketing Authorisation Holder was updated by a change of ownership to Wockhardt UK Limited. No new or unexpected safety concerns arose from these simple applications and it was, therefore, judged that the benefits of taking Aciclovir 200mg, 400mg and 800mg Tablets outweigh the risks, hence Marketing Authorisations have been granted. MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) -2- Aciclovir 200mg Tablets Aciclovir 400mg Tablets Aciclovir 800mg Tablets PL 29831/0517-9 SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introduction Page 4 Pharmaceutical assessment Page 5 Non-clinical assessment Page 8 Clinical assessment Page 9 Overall conclusions and risk benefit assessment Page 10 MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) -3- INTRODUCTION The Medicine and Healthcare Regulatory Agency (MHRA) granted Wockhardt UK Limited Marketing Authorisations for the medicinal products Aciclovir 200mg, 400mg and 800mg Tablets on 25 February 2013. These are prescription-only medicines (POM). Aciclovir belongs to a group of medicines called antivirals and indicated for the following: treatment of herpes simplex virus (HSV) infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding neonatal HSV and severe HSV infections in immunocompromised children) suppression of recurrent herpes simplex virus infections prevention of herpes simplex virus infections in immunocompromised patients treatment of herpes zoster infections. The antiviral activity of aciclovir is due to intracellular conversion to an active form that inhibits viral DNA (deoxyribonucleic acid) synthesis and replication by inhibiting the herpes virus DNA polymerase enzyme as well as being incorporated into viral DNA. Herpes simplex virus type 1 appears to be the most susceptible, then type 2, followed by varicella zoster virus. The Epstein-Barr virus and cytomegalovirus are also susceptible to aciclovir to a lesser extent. Aciclovir has no activity against latent viruses, but there is some evidence that it inhibits latent herpes simplex virus at an early stage of reactivation. These applications were submitted as simple abridged applications, according to Article 10(c) of Directive 2001/83/EC as amended, cross-referring to Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0001-3) authorised on 18 January 2007 to the Marketing Authorisation Holder Wockhardt UK Limited. Acilovir 200mg, 400mg and 800mg Tablets (PL 29831/0001-3), were originally granted Marketing Authorisations (PL 04543/0392-4) to CD Pharmaceuticals Limited on 29 June1999. On 18 January 2007, the Marketing Authorisation Holder was updated by a change of ownership to Wockhardt UK Limited No new data were submitted nor were they necessary for these simple applications, as the data are identical to those of the previously granted cross-reference products. MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) -4- PHARMACEUTICAL ASSESSMENT LICENCE NO: PL 29831/0517-9 PROPRIETARY NAME: Aciclovir 200mg, 400mg and 800mg Tablets ACTIVE(S): Aciclovir COMPANY NAME: Wockhardt UK Limited E.C. ARTICLE: Article 10(c) of Directive 2001/83/EC LEGAL STATUS: POM 1. INTRODUCTION These are simple, informed consent applications for Aciclovir 200mg, 400mg and 800mg Tablets submitted under Article 10(c) of Directive 2001/83/EC, as amended. The proposed Marketing Authorisation Holder is Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, United Kingdom. The applications cross-refer to Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0001-3), which were granted Marketing Authorisations to Wockhardt UK Limited on 18 January 2007. The current applications are considered valid. 2. MARKETING AUTHORISATION APPLICATION FORM 2.1 Name(s) The proposed names of the products are Aciclovir 200mg, 400mg and 800mg Tablets. The products have been named in line with current requirements. 2.2 Strength, pharmaceutical form, route of administration, container and pack sizes The products are for oral administration. Each tablet contains either, 200mg, 400mg or 800mg aciclovir. Aciclovir 200mg, 400mg and 800mg Tablets are packaged in aluminium blister packs. Aciclovir 200mg Tablets are available in packs of 25 or 100 tablets. Aciclovir 400mg Tablets are available in packs of 25, 30, 56, 60, 70 or 100 tablets. Aciclovir 800mg Tablets are available in packs of 35 tablets. The proposed shelf-life (36 months) and storage conditions (Do not store above 25°C) are consistent with the details registered for the cross-reference products. 2.3 Legal status On approval, the products will be available as prescription-only medicines (POM). 2.4 Marketing Authorisation Holder/Contact Persons/Company The Marketing Authorisation Holder is Wockhardt UK Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom. The Qualified Person (QP) responsible for pharmacovigilance is stated and their CV is included. 2.5 Manufacturers The proposed manufacturing sites are consistent with those registered for the cross-reference products and evidence of Good Manufacturing Practice (GMP) compliance has been provided. 2.6 Qualitative and quantitative composition The proposed compositions are consistent with the details registered for the cross-reference products. 2.7 Manufacturing process MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) -5- The proposed manufacturing process is consistent with the details registered for the cross-reference products and the maximum batch sizes are stated. 2.8 Finished product/shelf-life specification The proposed finished product specifications are in line with the details registered for the cross-reference products. 2.9 Drug substance specification The proposed drug substance specifications are consistent with the details registered for the crossreference products. European Directorate for the Quality of Medicines (EDQM) Certificates of Suitability for the drug substance manufacturers has been provided to support the manufacturing and control of the active substance. These details are in line with those of the reference products. 2.10 TSE Compliance With the exception of gelatine, lactose and magnesium stearate, none of the excipients contain materials of animal or human origin. A declaration that gelatine, lactose and magnesium stearate are free from BSE/TSE risk was provided. This is consistent with the cross-reference products. None of the excipients are sourced from genetically modified organisms. 2.11 Bioequivalence No bioequivalence data are required to support these simple abridged informed consent applications, as the proposed products are manufactured to the same formula utilising the same process as the cross-reference products Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0001-3). 3. EXPERT REPORTS The applicant cross-refers to the data for Aciclovir 200mg, 400mg and 800mg tablets (PL 29831/00013), to which they claim identicality. This is acceptable. 4. PRODUCT NAME & APPEARANCE See 2.1 for details of the proposed product names. The appearance of the products is identical to the respective cross-reference products. 5. SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) The proposed SmPCs are consistent with the details registered for the cross-reference products. 6. PATIENT INFORMATION LEAFLET (PIL) AND LABELLING PIL The patient information leaflet has been prepared in line with the details registered for the crossreference products. This PIL was submitted to the MHRA along with results of consultations with target patient groups (‘user testing’), in accordance with Article 59 of Council Directive 2001/83/EC. The results indicate that the leaflet is well-structured and organised, easy to understand and written in a comprehensive manner. The test shows that the patients/users are able to act upon the information that it contains. As the leaflet for the reference products and these products are considered the same, no further user testing of the leaflet for these products is necessary. Carton and blister The proposed artwork is comparable to the artwork registered for the cross-reference products and complies with statutory requirements. In line with current legislation, the applicant has also included the name of the products in Braille on the outer packaging. MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) -6- 7. CONCLUSIONS The data submitted with these applications are acceptable. The grant of Marketing Authorisations is recommended. MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) -7- NON-CLINICAL ASSESSMENT No new non-clinical data have been submitted with these applications and none are required for applications of this type. The Marketing Authorisation Holder has provided adequate justification for not submitting an Environment Risk Assessment (ERA). As the applications are for identical versions of an already authorised reference products, it is not expected that the environmental exposure to aciclovir will increase following the marketing approval of the products. The grant of Marketing Authorisations is recommended. MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) -8- CLINICAL ASSESSMENT No new clinical data have been submitted with these applications and none are required for applications of this type. The Marketing Authorisation Holder has provided details of a suitable pharmacovigilance system that fulfils the requirements and provides adequate evidence that the Marketing Authorisation Holder 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 either in the Community or in a third country. The Marketing Authorisation Holder has provided an adequate justification for not submitting a Risk Management Plan (RMP). As the applications are for identical version of already authorised reference products, for which safety concerns requiring additional risk minimisation have not been identified, a risk minimisation system is not considered necessary. The reference products have been in use for many years and the safety profile of the active ingredient is well-established. The grant of Marketing Authorisations is recommended. MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) -9- OVERALL CONCLUSION AND BENEFIT/RISK ASSESSMENT QUALITY The data for these applications are consistent with those previously assessed for the cross-reference products 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 identical to the previously granted applications for Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0001-3; Wockhardt UK Limited). SAFETY No new or unexpected safety concerns arise from these applications. PRODUCT LITERATURE The SmPCs, leaflet and labelling are satisfactory and consistent with those for the cross-reference products. BENEFIT/RISK 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 products. Extensive clinical experience with aciclovir is considered to have demonstrated the therapeutic value of the compound. The benefit/risk is, therefore, considered to be positive. MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) - 10 - Aciclovir 200mg Tablets Aciclovir 400mg Tablets Aciclovir 800mg Tablets PL 29831/0517-9 STEPS TAKEN FOR ASSESMENT 1 The MHRA received the marketing authorisation applications on 18 April 2012. 2 Following standard checks and communication with the applicant the MHRA considered the applications valid on 31 May 2012. Following assessment of the applications the MHRA requested further information on 29 June 2012. The applicant responded to the MHRA’s request, providing further information on 07 August 2012. The applications were determined on 25 February 2013. 3 4 5 MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) - 11 - Aciclovir 200mg Tablets Aciclovir 400mg Tablets Aciclovir 800mg Tablets PL 29831/0517-9 STEPS TAKEN AFTER ASSESSMENT Date submitted Application type Scope MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) Outcome - 12 - Aciclovir 200mg Tablets Aciclovir 400mg Tablets Aciclovir 800mg Tablets PL 29831/0517-9 SUMMARY OF PRODUCT CHARACTERISTICS The Summary of Product Characteristics for these products are published on the MHRA website. MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) - 13 - PRODUCT INFORMATION LABEL/LEAFLET MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) - 14 - MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) - 15 - MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) - 16 - MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) - 17 - MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) - 18 - MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) - 19 - MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) - 20 - MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) - 21 - MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) - 22 - PRODUCT INFORMATION LEAFLET The Patient Information Leaflet for these products is published on the MHRA website. MHRA PAR – Aciclovir 200mg, 400mg and 800mg Tablets (PL 29831/0517-9) - 23 -
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