tlo_seledyn.pdf 1 22.08.2017 14:38:01 C M Y CM MY CY CMY K DOSSIER LIST
tlo_seledyn.pdf 1 22.08.2017 14:38:01 PRODUCT NAME PHARMACEUTICAL FORM STRENGTH REFERENCE THERAPEUTIC CLASS ALIMENTARY TRACT & METABOLISM 1. Esomeprazole (sodium) infusion or injection 40 mg Nexium/ Antiulcerant 2. Omeprazole infusion 40 mg Losec/ Antiulcerant 3. Orlistat OTC Capsules 60 mg Alli/GSK Obesity treatment 4. Orlistat Capsules 120 mg Xenical/Roche Obesity treatment 5. Pantoprazole (sodium sesquihydrate) injection 40 mg Pantozol/Altana Antiulcerant 6. Sitagliptin (hydrochloride) NEW! 25 mg 50 mg 100 mg Januvia/Merck Oral antidiabetic 7. Sitagliptin (hydrochloride) + Metformin NEW! 50 mg + 500 mg 50 mg + 850 mg 50 mg+ 1000 mg Janumet/Merck Oral antidiabetic ANTI-INFECTIVES FOR SYSTEMIC USE 8. Aciclovir Tablets 200 mg 400 mg 800 mg Zovirax/GSK Antiviral for systemic use 9. Clarithromycin infusion 500 mg Klacid IV/Abbott Antibacterial for systemic use 10. Levofloxacin (hemihydrate) 250 mg 500 mg Tavanic/Sanofi- Aventis Antibacterial for systemic use 11. Levofloxacin (hemihydrate) Solution for infusion 5 mg/ml (100 ml) Tavanic/Sanofi- Aventis Antibacterial for systemic use 12. Linezolid 600 mg Zyvox/Pfizer Antibacterial for systemic use 13. Linezolid Solution for infusion 2 mg/ml (300 ml) Zyvox/Pfizer Antibacterial for systemic use 14. Tenofovir disoproxil (fumarate) 245 mg Viread/Gilead Science Antiviral for systemic use 15. Voriconazole 50 mg 200 mg Vfend/Pfizer Antifungal for systemic use BLOOD & BLOOD FORMING ORGANS 16. Rivaroxaban* NEW! 2.5 mg 10 mg 15 mg 20 mg Xarelto/Bayer Oral anticoagulant 17. Ticagrelor** NEW! 60 mg 90 mg Brilique/Astra- Zeneca Platelet aggregatioon inhibitor
AVAILABLE DOSSIERS PRODUCT NAME PHARMACEUTICAL FORM STRENGTH REFERENCE THERAPEUTIC CLASS CARDIOVASCULAR SYSTEM 18. Amlodipine (besilate) + Atorvastatin (calcium) 5 mg + 10 mg 10 mg + 10 mg 10 mg + 20 mg 5 mg + 20 mg Norvasc (Amlodipine) +Sortis (Atorvastatin)/ Pfizer Calcium-channel blocker & cholesterol & triglyceride regulator combination 19. Amlodipine (maleate) + Valsartan 5 mg + 80 mg 5 mg + 160 mg 10 mg + 160 mg Exforge/Novartis Calcium-channel blocker & angiotensin-ii antagonist combination 20. Amlodipine (maleate) + Valsartan + Hydrochlorothiazide* NEW! 10 mg + 160 mg + 12.5 mg 10 mg + 160 mg + 25 mg 10 mg + 320 mg + 25 mg 5 mg + 160 mg + 12.5 mg Exforge HCT/ Novartis Calcium-channel blocker & anigiotensin-ii antagonist & diuretic combination 21. Bosentan * 62.5 mg 125 mg Tracleer/Actelion Pulmonary arterial hypertension (PAH) treatment 22. Hydrochlorothiazide * Tablets 12.5 mg 25 mg Esidrex/Novartis Diuretic 23. Indapamide Prolonged-release tablets 1.5 mg Natrilix/Servier Diuretic 24. Metoprolol succinate Prolonged-release tablets 23.75 mg 47.5 mg 95 mg 190 mg Beloc-Zoc/ Beta blocking agent 25. Metoprolol tartrate Solution for injection 1 mg/ml (5 ml) Betaloc/ Beta blocking agent 26. Noradrenaline (tartrate) (1) Solution for injection 1 mg/ml (1 ml, 4 ml) -- Vasopressor and cardiac arrest management 27. Ramipril + Amlodipine (besilate) Capsules 5 mg + 5 mg 5 mg + 10 mg 10 mg + 5 mg 10 mg + 10 mg Tritace (Ramipril)/ Sanofi Aventis + Norvasc (Amlodipine)/ Pfizer Calcium-channel blocker & ACE inhibitor combination 28. Rosuvastatin (calcium) * 5 mg 10 mg 20 mg 40 mg Crestor/ Cholesterol & triglyceride regulator 29. Sildenafil (citrate) * 20 mg Revatio/Pfizer Pulmonary arterial hypertension (PAH) treatment DERMATOLOGICALS 30. Dimetindene Gel 1 mg/g (20g, 30g, 50g) Fenistil/Novartis Topical antipruritic GENITO-URINARY SYSTEM & SEX HORMONES 31. Tadalafil * 2.5 mg 5 mg 10 mg 20 mg Cialis/Eli Lilly Erectile dysfunction treatment 32. Vardenafil (hydrochloride) * 5 mg 10 mg 20 mg Levitra/Bayer Erectile dysfunction treatment
DYN.pdf 1 22.08.2017 14:38:01 March 2018 _SELEDYN.pdf 1 22.08.2017 14:38:01 PRODUCT NAME tlo_seledyn.pdf 1 22.08.2017 14:38:01 PHARMACEUTICAL FORM STRENGTH REFERENCE THERAPEUTIC CLASS MUSCULO-SKELETAL SYSTEM 33. Ibuprofen OTC Oral suspension 100 mg/ 5 ml (orange, raspberry, strawberry flavours) -- Non-steroid antiinflamatory and antirheumatic 34. Ibuprofen OTC Oral suspension 200 mg/ 5 ml (raspberry, strawberry flavours) -- Non-steroid antiinflamatory and antirheumatic NERVOUS SYSTEM 35. Atomoxetine (hydrochloride) Capsules 5 mg 10 mg 18 mg 25 mg 40 mg 60 mg 80 mg 100 mg Strattera/Eli Lilly ADHD treatment 36. Citalopram (hydrobromide) 10 mg 20 mg 30 mg 40 mg Seropram/ Lundbeck Antidepressant 37. Haloperidol Solution for injection 5 mg/ml (1 ml) Haldol/Janssen Antipsychotic 38. Memantine hydrochloride 10 mg 20 mg Ebixa/Lundbeck Alzheimer disease treatment 39. Propofol (1) Emulsion for injection or infusion 10 mg/ml (20 ml) Diprivan/ Anaesthetic 40. Quetiapine (fumarate) 25 mg 100 mg 150 mg 200 mg 300 mg Seroquel/ Antipsychotic OPHTHALMOLOGICALS 41. Bimatoprost 0.3 mg/ml (3 ml) Lumigan/ Allergan Miotic & antiglaucoma 42. 43. Bimatoprost + Timolol (maleate) Dorzolamide (hydrochloride) (0.3 mg + 5.0 mg) /ml (3 ml) Ganfort/Allergan Miotic & antiglaucoma 20 mg/ml (5 ml) Trusopt/MSD Miotic & antiglaucoma 44. Dorzolamide (hydrochloride)+ Timolol (maleate) (20 mg + 5 mg)/ml (5 ml) Cosopt/MSD Miotic & antiglaucoma RESPIRATORY SYSTEM 45. Hedera helix dry extract OTC Syrup 27,78 mg/5 ml (100 ml) -- Expectorant 46. Xylometazoline (hydrochloride) + Dexpanthenol (2) OTC Nasal spray solution (1 mg + 50 mg)/ml (10 ml) Nasic/Cassellamed Nasal descongestant & mucosal regenerator * Polpharma Group API ** Polpharma Group API + US dossier available (1) Dossier update not earlier than Q3 2019 (2) Dossier availability subject to some restrictions Herbal medicinal product For more information and up-dates regarding available dossiers and dossiers in development, please contact your assigned Sales Manager or our Commercial Department. Note: Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. Availability may be restricted to certain markets or countries.
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