National OTC Medicines List – First Edition 2018 NATIONAL OTC MEDICINES LIST First Edition 2018 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. FDA’s Center for Drug Evaluation and Research (CDER) regulates over‐the‐counter (OTC) which are drugs that have been found to be safe and appropriate for use without the supervision of a health care professional such as a physician, and they can be purchased by consumers without a prescription. Due to their therapeutic class, these medicines could be dispensed without physician’s intervention for diagnostic, treatment initiation or maintenance purposes. According to Arcle 43 of the Law No.367 issued in 1994 related to the pharmacy practice, and the amendment of Arcles 46 and 47 by Law No.91 issued in 2010, pharmacists do not have the right to dispense any medicine that is not requested through a unified prescription, unless the medicine is mentioned in a list which is established by the Orders of Pharmacists and Physicians In this regards, the Ministry of Public Health (MoPH) developed the National OTC list, presented it in a scientific, objective, reliable and accessible listingand issued by a Ministerial decision. At this stage, no “convenience size packaging” nor “restriction to a maximum dose” or a “maximum dose per day” or “length of treatment” were considered for some molecules to allow them to be classified as OTC. The list covers medicines that are intended to relief patients from minor to moderate symptoms for a determined period, and procured with the pharmacist’s assistance without the physician’s intervention. In developing the OTC Medicines List, reference was made to the French, UK, Switzerland, Canada, FDA and AESGP lists. hp://ansm.sante.fr/content/download/13055/158978/version/42/file/Medicaments‐Acces‐ Direct_Annexe‐1_Decembre‐2017.pdf http://www.aesgp.eu/ hps://www.swissmedic.ch/arzneimiel/00156/00221/00222/00230/index.html?lang=fr hps://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm10636 8.htm hp://www.sfda.gov.sa/ar/drug/search/Pages/drugdetails.aspx?did=4169&sm=human http://www.cpd‐pharma.ae/ https://www.pagb.co.uk/regulatory‐resources/otc‐medicines/ 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 Brand or Generic status Ingredients Code Registration number Brand name Strength Presentation Form Agent Manufacturer Country of manufacturing Responsible Party Name Responsible Country Name The list will be updated regularly to include any new additions. The National OTC medicines List welcomes comments from healthcare professionals. Please send comments to: [email protected] ﻻئحة اﻷدوية المسموح ببيعھا دون وصفة طبية (OTC) من قبل المؤسسات الصيدﻻنية Responsible Party Brand name Strength Presentation Form Code Registration number B/G Ingredient ATC Agent Manufacturer Country Responsible Party Name Country Tablet, N-acetylcysteine - 600mg, Vitamin C - Salutas Pharma GmbH for ACC LONG 10 5143 23624/06 G R05CB01 Mersaco Germany effervescent 75mg Hexal AG Activated charcoal - 70mg, Papaverine Pharmamedic ACTICARBINE 42 Comprimé 2481 78773 G A03E Elerte France HCl - 14mg S.A.R.L. Pharmanet Suspension, United Arab ADOL 250mg/5ml 135ml 1341 208895/03 G Paracetamol - 250mg/5ml N02BE01 Drugstore Julphar alcohol free Emirates S.A.R.L. Pharmanet United Arab ADOL 500mg 24 Caplet 3740 78846/98 G Paracetamol - 500mg N02BE01 Drugstore Julphar Emirates S.A.R.L. Paracetamol - 325mg, Pseudoephedrine Pharmanet United Arab ADOL ALLERGY SINUS 24 Caplet 1342 974456/00 G HCl - 30mg, Chlorpheniramine maleate - N02BE51 Drugstore Julphar Emirates 2mg S.A.R.L. Paracetamol - 325mg, Pseudoephedrine Pharmanet United Arab ADOL COLD 24 Caplet 1343 974216/01 G HCl - 30mg, Dextromethorphan HBr - N02BE51 Drugstore Julphar Emirates 15mg S.A.R.L. Pharmanet United Arab ADOL EXTRA 24 Caplet 1709 973937/02 G Paracetamol - 500mg, Caffeine - 65mg N02BE51 Drugstore Julphar Emirates S.A.R.L. Pharmanet Paracetamol - 325mg, Diphenhydramine United Arab ADOL PM 24 Caplet 1710 973888/02 G N02BE51 Drugstore Julphar HCl - 25mg Emirates S.A.R.L. Droguerie ADVIL 200mg 50 Tablet, coated 1564 405436/00 B Ibuprofen - 200mg M01AE01 Pfizer Canada Inc Canada Canada Mercury S.A.L. Ibuprofen - 200mg, Pseudoephedrine Droguerie ADVIL COLD & SINUS 20 Caplet, coated 1575 405437/00 B M01AE51 Pfizer Canada Inc Canada Canada HCl - 30mg Mercury S.A.L. Droguerie ADVIL LIQUI-GELS 200mg 32 Capsule 5787 218732/10 B Ibuprofen - 200mg M01AE01 Pfizer Canada Inc Canada Canada Mercury S.A.L. AERIALLERG 0.5mg/ml 125ml Syrup 6986 97366/12 G Desloratadine - 0.5mg/ml R06AX27 Mapico S.A.R.L. Pharma International Co Jordan Pharma International Co Jordan 05/08/2018 1/30 Quality Assurance of Pharmaceutical Products ﻻئحة اﻷدوية المسموح ببيعھا دون وصفة طبية (OTC) من قبل المؤسسات الصيدﻻنية Responsible Party Brand name Strength Presentation Form Code Registration number B/G Ingredient ATC Agent Manufacturer Country Responsible Party Name Country Tablet, film AERIALLERG 5mg 30 7562 167742/11 G Desloratadine - 5mg R06AX27 Mapico S.A.R.L. Pharma International Co Jordan Pharma International Co Jordan coated Pharmanet United Arab ALBENDA 200mg 2 Tablet 1350 973998/02 G Albendazole - 200mg P02CA03 Drugstore Julphar Emirates S.A.R.L. Pharmanet United Arab ALBENDA 400mg 20ml Suspension 1351 973999/02 G Albendazole - 100mg/5ml P02CA03 Drugstore Julphar Emirates S.A.R.L. ALMIRAL 1% w/w 50g Gel 8411 166818/11 G Diclofenac sodium - 1% w/w D11AX18 New Allpharma Medochemie Ltd Cyprus Medochemie Ltd Cyprus Solution pour Pierre Fabre Medicament ALOPEXY 2% 60ml application 2755 974104/01 G Minoxidil - 20mg/ml D11AX01 Mersaco France Pierre Fabre Dermatologie France Production cutanee Solution pour Pierre Fabre Medicament ALOPEXY 2% 3 x 60ml application 7189 186282/13 G Minoxidil - 20mg/ml D11AX01 Mersaco France Pierre Fabre Dermatologie France Production cutanee Diphenhydramine HCl - 13.5mg/5ml, Expectorant Pharmanet Sodium citrate - 57mg/5ml, Ammonium United Arab AMYDRAMINE 120ml Syrup, sugar 1352 973940/02 G R06AA52 Drugstore Julphar chloride - 131.5mg/5ml, Menthol - Emirates free S.A.R.L. 1mg/5ml Lidocaine HCl - 1mg, Dequalinium HCl - ANGINOVA 20 Lozenge 3847 26814 G A01AB New Allpharma Spirig Pharm AG Switzerland Medinova AG Switzerland 0.25mg Lidocaine HCl - 100mg/100ml, Hydrocortisone acetate - 60mg/100ml, ANGINOVAG 10ml Aerosol 2576 20112 G Tyrothricin - 400mg/100ml, Dequalinium R02A Spephal S.A.L. Ferrer International SA Spain chloride - 100mg/100ml, β-Glycerrhetinic acid 60mg/100ml Valerian root dry extract - 200mg, Hop Macromed ARDEYSEDON NACHT 50 Tablet, coated 8345 34915/1 G N05CM09 Ardeypharm GmbH Germany Ardeypharm GmbH Germany Stobile - 68mg S.A.R.L. Macromed ARDEYSEDON NACHT 20 Tablet, coated 8346 34815/1 G Valerian root dry extract - N05CM09 Ardeypharm GmbH Germany Ardeypharm GmbH Germany S.A.R.L. Tablet, ASPICOT 100mg 100 4673 261087/97 G Acetylsalicylic acid - 100mg B01AC06 Pharmaline S.A.L. Pharmaline SAL Lebanon Pharmaline SAL Lebanon enteric coated 05/08/2018 2/30 Quality Assurance of Pharmaceutical Products ﻻئحة اﻷدوية المسموح ببيعھا دون وصفة طبية (OTC) من قبل المؤسسات الصيدﻻنية Responsible Party Brand name Strength Presentation Form Code Registration number B/G Ingredient ATC Agent Manufacturer Country Responsible Party Name Country Tablet, ASPICOT 100mg 30 4680 261088/97 G Acetylsalicylic acid - 100mg B01AC06 Pharmaline S.A.L. Pharmaline SAL Lebanon Pharmaline SAL Lebanon enteric coated Droguerie R. Tablet, ASPIRIN PROTECT 100mg 20 7004 97499/12 B Acetylsalicylic acid - 100mg B01AC06 Pharaon & Fils Bayer Bitterfeld GmbH Germany Bayer Consumer Care AG Switzerland enteric coated S.A.L. Droguerie R. ASPIRINE 0.3g 30 Tablet 7635 50114/1 B Acetylsalicylic acid - 300mg N02BA01 Pharaon & Fils Bayer Bitterfeld GmbH Germany Bayer Consumer Care AG Switzerland S.A.L. Droguerie R. ASPIRINE C Tablet, Acetylsalicylic acid - 400mg, Vitamin C - 10 7709 61014/1 B N02BA51 Pharaon & Fils Bayer Bitterfeld GmbH Germany Bayer Consumer Care AG Switzerland EFFERVESCENT effervescent 240mg S.A.L. Adenosine (triphosphate disodic ATEPADENE 30mg 30 Gélules 3126 973374/01 B M03C Spephal S.A.L. Mayoly Spindler France trihydrate) - 30mg Vaginal AZONIT 1% 40g 3485 195060/04 G Isoconazole nitrate - 10mg/g G01AF07 Mapico S.A.R.L. Pharma International Co Jordan Pharma International Co Jordan Cream Diflucortolone valerate - 1mg/g, AZONIT - D 20g Cream 759 208552/03 G D07XC04 Mapico S.A.R.L. Pharma International Co Jordan Pharma International Co Jordan Isoconazole nitrate - 10mg/g Dextrose monohydrate - 25g/l, Citrate - 6 Bottles x240ml 30mEq/ml, Chloride - 35mEq/ml, Pharmaceuticals Solutions Pharmaceuticals Solutions BABYLYTE Oral Solution 957 973719/02 G A07CA Pharmamed Saudi Arabia Saudi Arabia /Pack Potassium - 20mEq/ml, Sodium - Industry Ltd Industry Ltd 45mEq/ml BATRAFEN NAIL Sanofi Aventis Deutschland Sanofi Aventis Deutschland 3g Solution 2705 135376 B Ciclopirox - 8g/100g D01AE14 Mersaco Germany Germany LACQUER GmbH GmbH Nicotinamide - 50mg, Calcium Pantothenate - 25mg, Biotin - 0.15mg, Droguerie R. Dragenopharm Apotheker BECOZYM FORTE 20 Dragée 1369 3561 B Vitamin B12 - 10mcg, Vitamin