DOSSIER LIST. tlo_seledyn.pdf :38:01 CMY K CM MY CY
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1 tlo_seledyn.pdf :38:01 C M Y CM MY CY CMY K DOSSIER LIST
2 tlo_seledyn.pdf :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 mg 50 mg mg 50 mg 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
3 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 mg 10 mg mg Exforge/Novartis Calcium-channel blocker & angiotensin-ii antagonist combination 20. Amlodipine (maleate) + Valsartan + Hydrochlorothiazide* NEW! 10 mg mg mg 10 mg mg + 25 mg 10 mg mg + 25 mg 5 mg mg 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 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
4 DYN.pdf :38:01 March 2018 _SELEDYN.pdf :38:01 PRODUCT NAME tlo_seledyn.pdf :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 Bimatoprost + Timolol (maleate) Dorzolamide (hydrochloride) (0.3 mg 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 Q (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.
5 WE OFFER High level of customer service Excellent products with CTD dossiers meeting EU requirements Regulatory knowledge and expertise Full support in developing registration strategies to meet the needs of our customers Execution and support in registration procedures upon customer s request QA service and pharmacovigilance service (PSUR) Intellectual property expertise Highly skilled and professional team of Project Managers Partnership in a win-win strategy
6 CONTACT POLPHARMA GROUP PHARMACEUTICAL WORKS Pelplińska Starogard Gdański Poland Phone: Fax: POLPHARMA B2B STRATEGIC PARTNER, FARMAPROJECTS Carrer Provença 392, 6ª Planta Barcelona (Spain) Phone: Fax: Meet us on LinkedIn:
CONTACT POLPHARMA GROUP POLPHARMA B2B
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