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National OTC Medicines List

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National OTC Medicines List National OTC Medicines List ‐ DraŌ 01 DRAFT National OTC Medicines List Draft 01 Ministry of Public Health of Lebanon This list was prepared under the guidance of His Excellency Minister Waêl Abou Faour andDRAFT the supervision of the Director General Dr. Walid Ammar. Editors Rita KARAM, Pharm D. PhD. Myriam WATFA, Pharm D Ghassan HAMADEH, MD.CPE FOREWORD According to the French National Agency for Medicines and Health Products Safety (ANSM), Over-the-counter (OTC) drugs are medicines that are accessible to patients in pharmacies, based on criteria set to safeguard patients’ safety. Due to their therapeutic class, these medicines could be dispensed without physician’s intervention for diagnostic, treatment initiation or maintenance purposes. Moreover, their dosage, treatment period and Package Insert Leaflet should be suitable for OTC classification. The packaging size should be in accordance with the dosage and treatment period. According to ArticleDRAFT 43 of the Law No.367 issued in 1994 related to the pharmacy practice, and the amendment of Articles 46 and 47 by Law No.91 issued in 2010, pharmacists do not have the right to dispense any medicine that is not requested by a unified prescription, unless the medicine is mentioned in a list which is established by pharmacists and physicians’ syndicates. In this regard, the Ministry of Public Health (MoPH) developed the National OTC Medicines List, and presentedit in a scientific, objective, reliable, and accessible listing. The OTC List was developed by a team of pharmacists and physicians from the Ministry of Public Health (MoPH). In order to ensure a safe and effective self- medicationat the pharmacy level, several pharmaceutical categories (e.g. cardiovascular medicines) and forms (e.g. injectable) were discarded at first sight. The list covers medicines that are intended to relieve patients from minor to moderate symptoms for a determined period, and procured with the pharmacist’s assistance without the physician intervention. These symptoms couldinvolve: moderate muscular pain, non infectious fever, cold, sore throat, labial herpes, gastric acidity and minor symptoms. In developing the OTC Medicines List, reference was made to the French OTC Drug List (2014), and to the Lebanese National Drug Index (LNDI-2015) which is the reference Guide for medicines in Lebanon. The National OTC Medicines List covers medicines, dosage forms, package sizes, drug strengths and other information registered at the MoPH. It is divided into sections based on the Anatomical Therapeutic Chemical (ATC) classification system. Each medication listing contains the following information: ATC code Ingredients Code Registration number Brand name Strength Presentation Form DRAFT Agent Manufacturer Country of manufacturing Responsible Party Name Responsible Country Name The National OTC medicines List welcomes comments from healthcare professionals. Please send comments to: [email protected]. Walid Ammar MD, Ph.D Director General Ministry of Public Health Registration Responsible Party Responsible ATC Ingredients Code Brand name Strength Presentation Form Agent Manufacturer Country number Name Party Country A ALIMENTARY TRACT AND METABOLISM Creosote - 10%, Phenol - 9.3%, Menthol - 9.3%, Chlorbutanol hemihydrate - 9.3%, Eugenol - MIXTURE A01 19.7%, Benzyl Alcohol - 42.4% 4811 14294 ODONTOLOGIQUE 4ml Liquid Mephico S.A.L. Mephico SAL Lebanon Chlorhexidine gluconate - 20mg/100ml, Sodium fluoride - 50mg/100ml, Lidocaine HCl - 3mg/100ml, A01AB Cetirimide - 25mg/100ml 1841 973918/02 CITROLIN F 120ml Solution C. Catafago & Co Pharco Pharmaceuticals Egypt Choline salicylate - 0.5g/100ml, Chlorbutanol hemihydrate - 0.25g/100ml, Hexetidine - A01AB 0.1g/100mlDRAFT 2865 236415/98 GIVALEX 125ml Soluté Unipharm S.A.L. Norgine Pharma France A01AB Lidocaine HCl - 1mg, Dequalinium HCl - 0.25mg 3847 26814 ANGINOVA 20 Lozenge New Allpharma Spirig Pharm AG Switzerland Medinova Ltd Switzerland Pharmanet ZORDYL MOUTH Drugstore United Arab A01AB03 Chlorhexidine gluconate - 0.1% 1647 208330/02 WASH 200ml Mouth wash S.A.R.L. Julphar Emirates A01AB03 Chlorhexidine - 0.119% 4601 20518 INDOLOR 0.119% 100ml Mouth wash Pharmadex Pharmadex Lebanon ELUDRIL Solution pour bains de Chlorhexidine - 0.5ml/100ml, Chlorbutanol bouche et Pharmaline Licensed by A01AB03 hemihydrate - 0.5g/100ml 4902 38908/96 gargarismes 90ml Solution Mersaco Pierre Fabre Santé, France Lebanon Chlorhexidine digluconate - 0.5ml/100ml, Mouthwash Pierre Fabre Medicament A01AB03 Chlorobutanol hemihydrate - 0.5g/100ml 7684 187187/13 ELUDRILPRO 500ml Solution Mersaco Production France Pierre Fabre Medicament France Chlorhexidine digluconate - 0.5ml/100ml, Mouthwash Pierre Fabre Medicament A01AB03 Chlorobutanol hemihydrate - 0.5g/100ml 7685 187186/13 ELUDRILPRO 200ml Solution Mersaco Production France Pierre Fabre Medicament France A01AB09 Miconazole nitrate - 20mg/g 4648 28560/93 MICONAZ 20mg/g 30 g Gel Pharmaline S.A.L. Pharmaline SAL Lebanon A01AB12 Hexetidine - 15mg/15ml 4669 974088/02 RINSIDIN 15mg/15ml 150ml Mouth wash Pharmaline S.A.L. Pharmaline SAL Lebanon Cetalkonium chloride - 0.01g/100g, Choline Gel for buccal Pierre Fabre Medicament A01AD salicylate - 8.7g/100g 2814 208961/03 PANSORAL 15g application Mersaco Production France Salicylic acid - 1g/100g, Rhubarb (Anthraquinone Gel Buccal & A01AD Glycosides) - 5g/100g 2878 236892/99 PYRALVEX 15g Gingival Omnipharma Norgine Pharma France Chloroform - 0.08g/100ml, Acriflavine - A01AD 0.004g/100ml, Phenol - 2g/100ml 4486 21459 DENTALGINE 120ml Solution Mephico S.A.L. Mephico SAL Lebanon Riyadh Pharma Medical Salicylic acid - 0.01g/ml, Rhubarb (Anthraquinone Riyadh Pharma Medical and and Cosmetic Products A01AD Glycosides) - 0.05g/ml 5724 218036/09 PYRALVEX 10ml Solution Unipharm S.A.L. Cosmetic Products Co Ltd Saudi Arabia Co Ltd Saudi Arabia Aluminium hydroxide - 400mg, Magnesium A02AD01 hydroxide - 400mg 3347 208966/03 MAALOX 400mg-400mg 40 Tablet, chewable Mersaco Sanofi Aventis SpA Italy Sanofi Aventis SpA Italy Simethicone - 25mg, Aluminium hydroxide - DIOVOL PLUS Mectapharm Church and Dwight Canada A02AF02 300mg, Magnesium hydroxyde - 100mg 1415 15276 (TROPICAL FRUIT) 50 Tablet S.A.L. Corp Canada Simethicone - 25mg/5ml, Aluminium hydroxide - DIOVOL PLUS Mectapharm Church and Dwight Canada A02AF02 165mg/5ml, Magnesium hydroxide - 200mg/5ml 1416 15275 (TROPICAL FRUIT) 350ml Suspension S.A.L. Corp Canada Dimethicone - 25mg, Aluminium hydroxide - A02AF02 200mg, Magnesium hydroxide - 200mg 3345 208964/03 MAALOX PLUS 30 Tablet Mersaco Sanofi Aventis SpA Italy Sanofi Aventis SpA Italy Simethicone - 25mg, Aluminium hydroxide - DIOVOL PLUS Mectapharm Church and Dwight Canada A02AF02 165mg, Magnesium hydroxide - 200mg 5036 15276 (MINT) 50 Tablet S.A.L. Corp Canada Simethicone - 25mg/5ml, Aluminium hydroxide - DIOVOL PLUS Mectapharm Church and Dwight Canada A02AF02 165mg/5ml, Magnesium hydroxide - 200mg/5ml 5037 15275 (MINT) 350ml Suspension S.A.L. Corp Canada Dimethicone - 0.5g/100g, Aluminium hydroxide - A02AF02 3.25g/100g, Magnesium hydroxide - 3.65g/100g 6479 208958/03 MAALOX PLUS 200ml Oral Suspension Mersaco Sanofi Aventis SpA Italy Sanofi Aventis SpA Italy Sodium alginate - , Sodium bicarbonate - , Calcium Droguerie Reckitt Benckiser Healthcare Reckitt Benckiser A02AH (carbonate) - 3510 195311/03 GAVISCON 16 Tablet Columbus UK UK Healthcare UK UK Sodium alginate - 500mg/10ml, Sodium bicarbonate - 267mg/10ml, Calcium (carbonate) - Droguerie Reckitt Benckiser Healthcare A02AH 160mg/10ml 3512 208746/03 GAVISCON 200ml Liquid Columbus UK UK Droguerie R. Magnesium carbonate - 80mg, Calcium carbonate - Pharaon & Fils A02AX 680mg 2824 973372/01 RENNIE 96 Tablet S.A.L. Delpharm Gaillard France A03AX Pepermint oil - 187mg 1025 27528 COLPERMIN 30 Capsule Taba Chemipharm Tilotts Pharma AG Switzerland A03AX Pepermint oil - 187mg 1026 27529 COLPERMIN 100 Capsule Taba Chemipharm Tilotts Pharma AG Switzerland Valeant Pharmaceuticals A03AX13 Simethicone - 40mg 1281 14102 DISFLATYL 30 Tablet Omnipharma Switzerland GmbH Switzerland A03AX13 Simethicone - 40mg/ml 1013 78896 INFACOL 50ml Suspension Taba Chemipharm William Ranson and Son PLC UK Forest Laboratories Ltd UK A03AX13 Simethicone - 40mg/ml 6725 97967/12 INFACOL 50ml Suspension Taba Chemipharm Purna Pharmaceuticals NV Belgium Forest Laboratories Ltd UK A03AX13 Simethicone - 40mg/ml 7501 186636/13 INFACOL 50ml suspension Taba Chemipharm Laleham Healthcare Ltd UK Forest Laboratories Ltd UK OVOL 180 MG Capsule, soft Mectapharm Church and Dwight Canada A03AX13 Simethicone - 180mg 1525 208598/03 ULTRA STRENGTH 180mg 32 gelatin S.A.L. Corp Canada Mectapharm Church and Dwight Canada A04AD Dimenhydrinate - 15mg/5ml 1453 22141/73 GRAVOL 15mg/5ml 75ml Liquid S.A.L. Corp Canada Page 1 Registration Responsible Party Responsible ATC Ingredients Code Brand name Strength Presentation Form Agent Manufacturer Country number Name Party Country Mectapharm Church and Dwight Canada A04AD Dimenhydrinate - 50mg 1454 405409/00 GRAVOL 50mg 30 Tablet, film coated S.A.L. Corp Canada Pharmamedic Pierre Fabre Medicament Pierre Fabre Medicament A05BA Arginine HCl - 1g/5ml 3869 567 ARGININE VEYRON 20 Ampoule Buvable S.A.R.L. Production France Production France HUILE DE A06AA01 Liquid paraffin - 4502 81/95 PARAFFINE 240ml Liquid Mephico S.A.L. Mephico SAL Lebanon A06AB05 Castor oil - 4503 80/95 HUILE DE RICIN 30ml Liquid Mephico S.A.L. Mephico SAL Lebanon A06AB05 Castor oil - 4504 80/95 HUILE DE RICIN 60ml Liquid Mephico S.A.L. Mephico SAL Lebanon A06AD04 Magnesium sulfate - 40g 4495 58/95
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