Retrieved March 2, 2015 2015 the resolution No. 224/MEDICINE: PRELUD.
MAh: Pharmaceutical A.G.I.P.S. S.r.l.-Via Amendola 4-16035 Rapallo-Genoa (GE).
Package «25 mg film-coated tablets» 2 tablets in PVC/AL-AIC # 042217012 (10) 188CKN (based on 32) Packaging «25 mg film-coated tablets» 4 tablets in PVC/AL-AIC # 042217024 (10) 188CL0 (based on 32) «50 mg film-coated tablets» 2 tablets in PVC/AL-AIC # 042217036 (10) 188CLD (based on 32) «50 mg film-coated tablets» 4 tablets in a blister PVC/AL-AIC # 042217048 (10) 188CLS (based on 32) «50 mg film-coated tablets» 8 tablets in PVC/AL-AIC # 042217051 (10) 188CLV (based on 32) Packaging «100 mg film-coated tablets» 4 tablets in PVC/AL-AIC # 042217063 (10) 188CMZ (based on 32) Packaging «100 mg film-coated tablets» 8 tablets in PVC/AL-AIC # 042217075 (10) 188CMM (based on 32) dosage form: tablets.
Composition: each tablet contains: active ingredient: sildenafil 25 mg (equivalent to 35.121 mg sildenafil citrate).
sildenafil 50 mg (equivalent to 70.141 mg sildenafil citrate).
100 mg sildenafil (equivalent to 140.482 mg sildenafil citrate).
Other ingredients: Tablet core: croscarmellose sodium Calcium hydrogen phosphate, microcrystalline cellulose, magnesium stearate Film-coating: lactose monohydrate Hypromellose Triacetin titanium dioxide (E171) production active ingredient: Hetero Drugs Limited s. Nos. 213, 214 and 255, Jinnaram Mandal, Medak District 502 313 Bonthapally Village, Andhra Pradesh India Cadila Pharmaceuticals Limited 294 G.I.D.C. Industrial Estate, Ankleshwar, Gujarat India manufacturing and packaging 393 002: Jubilant Generics Limited Village Sikandarpur Bhainswal, Bhagwanpur, Roorkee, Roorkee Dehradoon Distr., Haridwar, Uttarakhand, India 247 661 outer packaging (application bollino IPZS): PB Badsha S.r.l.
via s. Erasmo 6 Rescaldina batch control: Zeta Analitical Limited Unit 3, Colonial Way, Watford, Herts, United Kingdom WD24 4 yr Kennet Bioservices Ltd.
6 Kingsdown Orchard, Hyde Road, Swindon, Wiltshire SN2 7RR United Kingdom MCS Laboratories Ltd.
Units 8 and 9 Rockmill Business Park, The Dale, Stoney Middleton, Hope Valley, United Kingdom South Yorkshire S32 4TF Astron Research Ltd.
nd nd 2 Floor 3 & Sage House, 319 Pinner Road, Harrow HA1 4HF United Kingdom release: PSI supply nv Axxes Business Park, Guldensporenpark 9820 Merelbeke Belgium 22, Block C, medical indications: the treatment of subjects with erectile dysfunction, which is the inability to attain or maintain a penile erection sufficient for satisfactory sexual activity.
Sexual stimulation is required for PRELUD can be effective.
Classification for the purposes of new listings ' Pack ' 25 mg film-coated tablets» 2 tablets in PVC/AL-AIC # 042217012 (10) 188CKN (based on 32).
New listings ' class ' C '.
Package «25 mg film-coated tablets» 4 tablets in PVC/AL-AIC # 042217024 (10) 188CL0 (based on 32) new listings ' class ' C ' Pack ' 50 mg film-coated tablets» 2 tablets in PVC/AL-AIC # 042217036 (10) 188CLD (based on 32) new listings ' class ' C ' Pack ' 50 mg film-coated tablets» 4 tablets in PVC/AL-AIC # 042217048 (10) 188CLS (based on 32) new listings ' class ' C» «Pack 50 mg film-coated tablets» 8 tablets in PVC/AL-AIC # 042217051 (10) 188CLV (based on 32) new listings ' class ' C ' Pack ' 100 mg film-coated tablets» 4 tablets in PVC/AL-AIC # 042217063 (10) 188CMZ (based on 32) new listings ' class ' C ' Pack ' 100 mg film-coated tablets» 8 tablets in PVC/AL-AIC # 042217075 (10) 188CMM (32) new listings ' ' C ' Classification for the purpose of the classification for the purposes of providing the medicine PRELUD is as follows: medicinal product subject to medical prescription (RR).
Printed packaging of the medicinal product should be marketed with labels and package leaflets comply with the text annexed to this determination.
It approved the summary of the product characteristics attached to this determination.
Periodic safety update reports PSUR-).
At the time of granting the authorisation, the submission of the periodic safety update reports not required for this product. However, the marketing authorisation holder shall submit periodic safety update reports for this product if the product is listed as reference dates (EURD list) referred to in article 107-quater, para. 7 of Directive 2010/84/EC and published on the web portal of the European Medicines Agency.
Date of determination: from the day following its publication in the official journal of the Italian Republic.