AVAILABLE DOSSIERS. Product name Pharmaceutical form Strength Reference Therapeutic class

Transcription

1 DOSSIER LIST

2 AVAILABLE DOSSIERS Product name Pharmaceutical form Strength Reference Therapeutic class ALIMENTARY TRACT & METABOLISM Esomeprazole sodium Omeprazole sodium injection / 40 mg Nexium / AstraZeneca Antiulcerant 40 mg Losec / Astra Zeneca Antiulcerant Orlistat Capsules 60 mg mg Alli / GSK - Xenical / Roche Obesity treatment Pantoprazole sodium sesquihydrate injection / 40 mg Pantozol / Altana Antiulcerant ANTI-INFECTIVES FOR SYSTEMIC USE Aciclovir Tablets 200 mg mg mg Zovirax / Glaxo Antiviral for systemic Ciprofloxacin hydrochloride Clarithromycin Levofloxacin hemihydrate Levofloxacin hemihydrate 250 mg mg Ciproxin / Bayer 500 mg Klacid IV / Abbot 250 mg mg Tavanic / Aventis Solution for 250 mg / 50ml mg / 100ml Tavanic / Aventis Linezolid 600 mg Zyvox / Pfizer Linezolid Solution for 2 mg/ml Zyvox / Pfizer Voriconazole 50 mg mg Vfend / Pfizer Antifungal for systemic Voriconazole 200 mg Vfend / Pfizer Antifungal for systemic ANTINEOPLASTIC & IMMUNOMODULATING AGENTS Bicalutamide 50 mg mg Casodex / AstraZeneca Cytostatic hormone antagonist (Anti-androgens) Imatinib 100 mg mg mg Glivec / Novartis Antineoplastic CARDIOVASCULAR SYSTEM Bosentan * NEW! 62.5 mg mg Tracleer / Actelion Pulmonary arterial hypertension (PAH) treatment Candesartan cilexetil Tablets 4 mg - 8 mg - 16 mg - 32 mg Atacand / AstraZeneca Angiotensin-II antagonist

3 AVAILABLE DOSSIERS Product name Pharmaceutical form Strength Reference Therapeutic class CARDIOVASCULAR SYSTEM Hydrochlorothiazide * Tablets 12.5 mg - 25 mg --- Diuretic Indapamide Prolonged-release tablets 1.5 mg Natrilix / Servier Diuretic Metoprolol succinate Prolonged-release tablets mg mg - 95 mg mg Beloc-Zoc / AstraZeneca Beta blocking Olmesartan medoxomil 10 mg - 20 mg - 40 mg Benicar / Daiichi Sankyo Angiotensin-II antagonist Olmesartan medoxomil + Hydrochlorothiazide 20 mg mg - 20 mg + 25 mg - 40 mg mg - 40 mg + 25 mg Olmetec Plus / Daiichi Sankyo Angiotensin-II antagonist & diuretic combination Rosuvastatin calcium * 5 mg - 10 mg - 20 mg - 40 mg Crestor / AstraZeneca Cholesterol & triglyceride regulator Simvastatin 10 mg - 20 mg - 40 mg - 80 mg Zocor / MSD Cholesterol & triglyceride regulator Valsartan 80 mg mg Diovan / Novartis Angiotensin-II antagonist DERMATOLOGICALS Dimetindene Gel 1 mg/g Fenistil / Novartis Topical antipruritic GENITO-URINARY SYSTEM & SEX HORMONES Vardenafil hydrochloride * NEW! 5 mg - 10 mg - 20 mg Levitra / Bayer Erectile dysfunction treatment MUSCULO-SKELETAL SYSTEM Alendronic acid * Tablets 70 mg Fosamax / Merck Bone calcium regulator NERVOUS SYSTEM Aripiprazole * Tablets 5 mg - 10 mg - 15 mg - 30 mg Abilify / Otsuka Ltd / BMS Antipsychotic Atomoxetine Capsules 5 mg - 10 mg - 18 mg - 25 mg - 40 mg - 60 mg - 80 mg mg Strattera / Eli Lilly ADHD treatment Citalopram hydrobromide 10 mg - 20 mg - 30 mg - 40 mg Seropram / Lundbeck Antidepressant

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5 We offer: High level of customer service Excellent products with CTD dossier meeting EU requirements Regulatory knowledge and expertise Full support in developing registration strategies to meet the customer s needs Execution and support of registration procedures upon customer s request QA service and Pharmacovigilance service (PSUR) Intellectual property expertise Professional and competent team skilled in project management techniques Partnership in a win-win strategy CONTACT POLPHARMA GROUP Pharmaceutical Works Pelplińska Starogard Gdański Poland Phone: Fax: POLPHARMA B2B STRATEGIC PARTNER, FARMAPROJECTS Santa Eulàlia L Hospitalet de Llobregat Barcelona (Spain) Phone: Fax salesb2b@polpharma.com