FALCÃO TELES LDA. Dossier List
Transcrição
FALCÃO TELES LDA. Dossier List
FALCÃO TELES LDA. Dossier List AVA AILABLE DOSSIERS Prroduct Name Pharm maceutical Form m Strength S Refereence Therapeutic cla ass 1 ylsalicylic acid+ + Acety Phenyle ephrine bitartratte+ Chlorphenamine malea ate * er for oral solutio n Powde 500mg+ +15,58mg +2mg - Cough and Co old 2 Acety ylsalicylic acid+ + Phenyle ephrine bitartratte * Orodis spersible powderr (cola taste) 500m mg+15,58mg - Cough and Co old 3 ylsalicylic acid + Acety Ascorbic acid + Caffein ne * Powde er for oral solutio n 500mg+ +50mg +300mg - Cough and Co old 4 Aciclovir 1 Tablets 200mg – 400mg – 800mg g Zovirax / Glaxo Antiviral 5 Amoldip pine + Atorvasta atin Film m-coated tablets 5m mg+10mg 10mg+10mg Caduet / Pfizer Calcium C antagon nist + Lipid L modifying agent a 6 Alendronic acid 1 Tablets 70mg Fosamax / Merck Bo one calcium regu ulators 7 Aripiprazole 1 Tablets 5mg – 10mg 1 – 15mg – 30mg Abilify / Brisstol-Myers Squibbb Antipsychoticcs 8 Betaxo olol hydrochlorid de Eye drops, solution 5 mg/ml Betoptic//Alcon Anttiglaucoma prepa arations and miotics 9 B Bicalutamide Film m-coated tablets 50m mg - 150 mg Casodex / AstraZ. Anti-neoplastic A ag gents Antiglaucoma preparation and miotics (o orange taste) (llemon taste) 10 B Bimatoprost Eye drops 0,3 mg/ml Lumigan /A Allergan Pharmaceeuticals 11 aine hydrochlorride Bupivaca Soluttion for injection 5 mg/ml Marcain / AsttraZeneca Anesthetics, local 12 C Candesartan Tablets 4mg - 8mg - 16mg - 32mg g Atacand / AstraZ. Angiotensin II antag gonists 13 Ciprofloxacin Tablets 250m mg – 500mg Ciproxin / Bayer Che emotherapeutic antibiotic a 14 C Citalopram Film m-coated tablets Seropram / LLundbeck Antidepressan nts 15 C Citalopram Oral O solution 40mg/ml 4 Seropram / LLundbeck Antidepressan nts 16 C Citalopram Concenttrate for solution for infusion 20mg/0,5ml - 40mg/1ml Seropram / LLundbeck Antidepressan nts 17 Cla arithromycin Powde er for solution forr infusion 500mg Klacid IV / Abbot Macrolide M Antibaccterial 18 De esloratadine Film m-coated tablets 5mg Neoclarityn / Schering Anti-histamines for systemic s use 19 esloratadine De Oral O solution 0,5mg/ml 0 Neoclarityn / Schering Anti-histamines for systemic s use 20 D Dorzolamide Eye drops, solution 20 2 mg/ml Trusopt / Merck Anttiglaucoma prepa arations and miotics 21 D Doxylamine Tablets 15m mg - 25mg Hoggar nighht / Stada Antihistamines for systemic use 22 Enalapril Tablets 5mg – 10mg – 20mg Renitec / MSD ACE inhibitor 23 Enalapril Table ets with breaklinee 5mg – 10mg – 20mg Xanef / MSD ACE inhibitorrs Tablets 20m mg+12,5mg CoRenitec ec/MSD AC CE inhibitors + diuretics 25m mg - 50mg Inspra / P Pfizer Pota assium-sparing diuretics d Cipralex / LLundbeck Antidepressan nts 24 Ena alapril +HCTZ 1 10m mg - 20mg – 30mg g - 40 mg 25 E Eplerenone Film m-coated tablets 26 Escitalopram Film m-coated tablets 27 someprazole Es Powde er for solution forr injec ction / perfusion 40mg Nexium / A AstraZ. Acid A Related diso orders 28 Fenspiride Syrup 2mg/ml Pneumorel / Servier Obs structive airway diseases d 29 Fenspiride Tablets 80mg Pneumorel / Servier Obs structive airway diseases d 30 G Gabapentin Hard capsules 100mg - 300mg - 400mg Neurontin / Pfizer Antiepilepticc 31 H Haloperidol Soluttion for injection 5 mg/ml Haldol / Jaanssen Antipsychoticcs 32 Hy yaluronic acid Eye drops - Artificial tearss 5mg g - 10mg – 15m mg - 20mg 0,1% % 0,5 ml x 12 0,1% bottle b 2 x 5ml 1/4 FALCÃO TELES LDA. Dossier List AVA AILABLE DOSSIERS Prroduct Name Pharm maceutical Form m Strength S Refereence Therapeutic cla ass 33 Ibuprofen Ora al - suspension 10 00mg/ 5ml 20 00mg/5 ml Nurofen / Reckitt Benckkiser Antiinflammatory A y and antiheumaticss 34 Ind dapamide SR Prolong ged-release tableets 1,5mg Natrilix / S Servier Diuretics 35 Irbesartan Film m-coated tablets 75mg – 150mg 1 – 300mg Aprovel / Sanofi Angiotensin II antag gonists 36 Irbes sartan+HCTZ 1 Film m-coated tablets Co-Aprovell / Sanofi Angiotensin II antag gonists + diuretics Keppra / UCB B Pharma Antiepilepticc 150m mg+12,5mg 300mg+12,5mg 300 0mg+25mg 250m mg - 500mg 37 Le evetiracetam Film m-coated tablets 38 Le evetiracetam Concenttrate for solution for infusion 100mg/ml Keppra / UCB B Pharma Antiepilepticc 39 evetiracetam Le Oral O solution 100mg/ml Keppra / UCB B Pharma Antiepilepticc 40 L Levofloxacin Solution for infusion 250mg/50m ml – 500mg/100m ml Tavanic / A Aventis Quinolone Q Antibaccterial 41 L Levofloxacin Film m-coated tablets 250m mg – 500mg Tavanic / A Aventis Quinolone Q Antibaccterial 42 Linezolid Solution for infusion 2mg/ml Zyvox / P Pfizer Antib bacterial for syste emic use 43 Losartan Film m-coated tablets Cozaar / MSD Angiotensin II antag gonists 44 Los sartan +HCTZ Film m-coated tablets 50m mg+12,5mg 100 0mg+25mg Cozaar Pluus / MSD Angiotensin II antag gonists + diuretics 45 M Meloxicam Soluttion for injection 15 5mg/1,5ml Movalis / BooehringerIngelheeim Anti-inflammato ory, antirheumaticc 46 M Memantine Film m-coated tablets 10m mg – 20 mg Ebixa / Luundbeck Anti-dementia drrugs 47 M Memantine Oral drops 10mg/g Ebixa / Luundbeck Anti-dementia drrugs 48 Metopro olol Succinate SR S Prolong ged release tableets 23,75 5mg - 47,5mg - 95m mg - 190mg Beloc-Zoc / AstraZ. Beta B blocking ag gents 49 Montelukast 1 M Film m-coated tablets 10mg Singulair / Merck Obs structive airway diseases d 50 M Montelukast ¹ Che ewable tablets 4m mg - 5mg Singulair / Merck Obs structive airway diseases d 51 M Montelukast ¹ Sachets 4mg Singulair / MSD Obs structive airway diseases d 52 No oradrenaline Soluttion for injection 1 mg/ml Noradrenalinee / Hospira Adre energic and dopa aminergic agents 53 O Olanzapine Tablets 5mg - 10m mg - 15mg - 20mg g Zyprexa / Lilly Antipsychoticcs 54 Ola anzapine ODT Orodispersible tabletss 5mg - 10m mg - 15mg - 20mg g Zyprexa / Lilly Antipsychoticcs 55 O Olmesartan Film m-coated tablets 10mg – 20mg – 40mg Benicar / Daiicchi Sankyo Angiotensin II antag gonists 56 O Olopatadine Eye drops 0,1% Pataday / Alcon Eyes allergies 57 O Omeprazole Powde er for solution forr infusion 40mg Losec / A Astra Z. Acid A related disorders 58 O Ondansetron Soluttion for injection 4mg/2 2ml - 8mg/4ml Zofran / GSK Antiemetics an nd antinauseants 59 Ond dansetron ODT Orodispersible tabletss 4m mg - 8mg Zofran / GSK Antiemetics an nd antinauseants 60 O Opipramol 1 Film m-coated tablets 50mg Insidon / N Novartis Antidepressant, An nxiolytic 61 Orlistat Capsules 60m mg - 120mg Xenical / Roche An ntiobesity preparrations - 750m mg - 1000mg 12,5 5mg - 25mg - 50m mg - 100mg 62 Oxymetazzoline hydrochlo oride Nasa al spray, solution 0.025 mg g/ml, 0.05 mg/ml Nasivin / Merck De econgestants and d other nasal preparatio ons for topical use e 63 Pantoprazole Lyophilis sate for solution for infu usion/injection 40mg Pantozol / Altana Acid A related disorders 64 P Perindopril Tablets 4m mg - 8mg Coversyl / Servier ACE inhibitorrs 2/4 FALCÃO TELES LDA. Dossier List AVA AILABLE DOSSIERS Prroduct Name Pharm maceutical Form m Strength S Refereence Therapeutic cla ass P Piracetam1 Film m-coated tablets 800m mg – 1200mg Nootropil / UCB Nootropic 66 Propofol Emulsiion for injection oor infusion 10 mg/ml Diprivan / Ast straZeneca Anesthetics, gen neral 67 Q Quetiapine Film m-coated tablets 25mg – 10 00mg – 150mg – 200m mg – 300mg Seroquel / AstraZ. Antipsychoticcs 68 Ro osuvastatin 2 Film m-coated tablets 5mg – 10m mg – 20mg – 40m mg Crestor / A AstraZ. Lipid L modifying ag gents 69 Salicylam mide + Ascorbic acid + Ru utoside + Zinc Coated C tablet 300 mg m + 200 mg +50 0 mg + 5mg - Cold preparatio ons 70 Sild denafil citrate ¹ Tablets 25mg – 50 5 mg – 100mg Viagra / Pfizer Erec ctile dysfunction products 71 S Simeticone Oral drops 66 6,66mg/ml - Alimentary A Tractt and Metabolism 72 S Simvastatin Film m-coated tablets 10mg – 20mg 2 – 40mg – 80mg Zocor / MSD Lipid L modifying ag gents 73 S Sumatriptan Film m-coated tablets 50m mg - 100mg Imitrex / GSK Antimigraine dru ugs 74 T Tianeptine Film m-coated tablets 12,5mg Coaxil / S Servier Antidepressan nts 75 T Tobramycin Eye drops, solution 3 mg/ml Tobrex / Alcon Antiinfectivess 76 T Topiramate 2 Tablets Topamax / Orrtho-McNeil Antiepilepticc 77 dol+ Paracetam mol Tramad Film m-coated tablets 37,5 5mg/ 325mg Zaldiar/Grüünenthal Analgesics 78 T Travoprost Eye drops 0,,04mg/ml Travata tan / Alcon Laboraatories Ltd Antiglaucoma preparation and miotics 79 Valsartan Film m-coated tablets 80m mg – 160mg Diovan / N Novartis Angiotensin II antag gonists 80 Vals sartan +HCTZ1 Film m-coated tablets 160 0+12,5mg Co-Diovan / Novartis Angiotensin II antag gonists + diuretics 65 25m mg – 50mg – 100 0mg – 200mg 80 0+12,5mg 16 60+25mg 81 V Venlafaxine Tablets 25m mg - 37,5mg - 50 0mg –75mg Effexor / W Wyeth Antidepressan nts 82 Ve enlafaxine SR Prolonge ed release capsuules 37,5mg - 75mg - 150mg Effexor XR R / Wyeth Antidepressan nts 83 V Voriconazole Film m-coated tablets 50m mg– 200mg Vfend /P Pfizer Anti-fungal age ents 84 Xy ylometazoline Nasal sprray, solution soluution 1 mg/m ml, 0.5 mg/ml Otrivin / N Novartis De econgestants and d other nasa al preparations fo or topical use 85 Zole edronic Acid ¹ Concenttrate for solution for infusion 4mg/5ml 4 Zometa / N Novartis Drugs affecting bo ones & mineralisation n 86 Zole edronic Acid ¹ Powder for concentrate ffor infusion 4mg/5ml 4 Zometa / N Novartis Drugs affecting bo ones & mineralisation n 1 based on APII from Business Unit U Fine Chemic cals, Polpharma (BUFC) dossier based d on API from firsst supplier, API from f BUFC will bbe registered as a second supplie er later * limited offer te erritory (excluding g Spain, Portuga al, Greece) 2 DOS SSIERS UN NDER DEV VELOPMENT T in 2013 P Product Name Pharmaceutical Form Strength Reference Therapeutic class c Expe ected 1 Amoldipine + Atorvasttatin ated tablets Film-coa 5mg+20mg 10mg+20mg Caduett / Pfizer Calcium antago onist + Lipid modifying agent 3Q 2013 2 Diosmin Gel G 50g - Chronic veno ous insufficiency (cosmetic) 2Q 2013 3 Diosm min + Vitis vinife era + Ruttine + Tocopherrol Ca apsule 300mg +25mg+50mg - Chronic veno ous insufficienc cy (food supplem ment) 1Q 2013 4 Linezolid Film-coa ated tablets 600mg Zyvox x /Pfizer Antibacterials s for systemic us se 4Q 2013 3/4 FALCÃO TELES LDA. Dossier List DOS SSIERS UN NDER DEV VELOPMENT T in 2013 1 P Product Name Pharmace eutical Form Strength Refe erence Therapeutic class c Expe ected 5 Mettamizole sodium m Gel capsules c 500mg - Analgesics s 2Q 2013 2 6 M Moxifloxacin Eye e drops 15mg/3ml Vigamo ox / Alcon Q Quinolone Antiba acterials 1Q 2013 2 Benicar HCT H / Daiichi Sankyo Angiotensin n II antagonists + diuretic 1Q 2013 2 7 Olm mesartan+HCTZ Z Film-coa ated tablets 20mg+12,5mg 20mg+25mg 40mg+12,5mg 40mg+25mg 8 etamol + Ibupro ofen Parace Ta ablets 325mg+200mg g - Analgesics s 2Q 2013 2 9 P Posaconazole Oral su uspension 440mg/ml (105ml) Noxafil / Merck M & Co Antifungal 4Q 2013 2 10 Pregabaline Capsules 255mg -75mg -100m mg - 150mg - 200mg g225mg - 300mg g Lyrica a /Pfizer Antiepileptics 2 3Q 2013 11 Salicy ylamide + Ascorrbic acid + Rutoside + Zin nc Powder for oral solution - Cold preparattions 3Q 2013 2 12 S Simethicone Capsule twist-off 20mg - Alimentary Trac ct and Metabolism m (medical dev vice) 1Q 2013 2 13 S Simethicone Ora al drops 135mg/ml - Alimentary Trac ct and Metabolism m (medical dev vice) 1Q 2013 2 14 Vardenafil 1 Coate ed tablets 5m mg – 10mg – 20m mg Levitra a / Bayer Erectile dysfun nction products 1Q 2013 2 15 V Voriconazole Inffusion 200mg Vfend d /Pfizer Anti-fungal ag gents 2Q 2013 2 3300 mg + 300 mg g + 50 mg + 5mg based on API from Business Unit U Fine Chemic cals, Polpharma ((BUFC) D DCP SLOT in i 2013 Produ uct Name Ph harmaceutical Form F DCP Slot 1 Ibu uprofen Oral suspensio on March 2013 2 Olmesa artan+HCTZ Film-coated tablets January 2013 3 Voric conazole Infusion November N 2013 For more inform mation and up-da ates regarding av vailable dossiers and dossiers in development, ple ease contact youur assigned Sales Manager or ou ur Commercial De epartment. Note: Products protected by vallid patents are no ot offered for salee in countries wh here the sale of such s products coonstitutes patent infringement. Availability mayy be restricted to certain markets or countries. 4/4