YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha .eiÜ m;%h w;s úfYI The Gazette of the Democratic Socialist Republic of Sri Lanka EXTRAORDINARY wxl 2144$20 - 2019 Tlaf;dan¾ ui 09 jeks nodod - 2019'10'09 No. 2144/20 - WEDNESDAY, OCTOBER 9, 2019 (Published by Authority) PART I : SECTION (I) — GENERAL Government Notifi cations Order No. 01 NATIONAL MEDICINES REGULATORY AUTHORITY ACT, NO. 5 OF 2015 Order under section 60 (2) BY VIRTUE of the powers vested in me by section 60 (2) of the National Medicines Regulatory Authority Act, No. 5 of 2015, I, Prof. Asita De Silva, Chairman of the National Medicines Regulatory Authority, do by this Order, inform the public that the medicines specifi ed in the Schedules here to have been registered with the National Medicines Regulatory Authority. Prof. ASITA DE SILVA Chairman, (For and on behalf of) National Medicines Regulatory Authority Colombo August 8, 2019 1A—PG 4679 - 257 (10/2019) This Gazette Extraordinary can be downloaded from www.documents.gov.lk 2 SCHEDULE - I P ART I:S COLUMN-I COLUMN-II COLUMN- COLUMN-IV COLUMN-V COLUMN- COL- COL- EC III VI UMN-VII UMN-VIII I . (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA -09.10.2019 REPUBLICOFSRILANKA SOCIALIST THE DEMOCRATIC OF . (I)-GAZETTEEXTRAORDINARY fldgi (^ Offi cial Name Brand Name Dosage Importer Manufacturer Man- Issue Reg. Form Name Country Date Type 1 BENZALKONIUM CHLORIDE,CETRIMID 0.01%,0.2% DRAPOLENE CREAM GlaxoSmithkiline Glaxo Smithkiline POLAND 24-Mar- Full I & fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜm;%h-2019'10'09 -YS%,xldm%cd;dka;s%liudcjd§ckrcfhaw;súfYI & fPoh Pharmaceuti clas Pharmaceuti clas 14 (Pvt) Ltd 2 CHLORHEXIDINE GLUCONATE 2.5%+ISOPROPYL SANISCUB C SOLUTION Ceyoka (Pvt) Ltd Sirmaxo INDIA 07-Jan-15 Full ALEOHOL BP 70% Chemicals Pvt Ltd 3 CHLOROXYLENOL LIQUID 4.8% APPLICATION DETTOL LIQUID N/A CDDEF Manu- SRI LANKA 01-Jan-18 Provisional facturers & Mer- chants for Rekitt Benkiser 4 DICHLOROBENZYL ALCOHOL 1.2mg STREPSILS LOZENGES Reckitt Reckitt Benckser THAILAND 28-Apr-15 Full (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES HONEY & Benckiser Healthcare LEMON (Lanka) Ltd 5 DICHLOROBENZYL ALCOHOL 1.2mg STREPSILS COOL LOZENGES Reckitt Reckitt Benckiser THAILAND 28-Apr-15 Full (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES Benckiser Healthcare UK (Lanka) Ltd Ltd 6 DICHLOROBENZYL ALCOHOL 1.2mg STREPSILS LOZENGES Reckitt Reckitt Benckser THAILAND 28-Apr-16 Full (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES ORIGINAL Benckiser Healthcare (Lanka) Ltd 7 DICHLOROBENZYL ALCOHOL 1.2mg THERASIL LOZENGES George Steuart Plethico Pharma- INDIA 05-Apr-15 Full (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES Health (Pvt) Ltd ceuti cals Ltd 8 GLIPE MIXTURE WITH OIL OF AMITHI B PBCO MORISON S SYRUP N/A M S J Industries SRI LANKA 14-Jun-17 Two Years 1% SODIUM BICARBONATE 1.0% & ZIMGIBAR GRIPE MIXTURE (Ceylon) (Pvt) Ltd OFFICINALE (GINGER) EXTRACT 0.48% FOR CHILDREN 4 9 INFANT CARMINATIVE SYRUP OIL OF ANETHI BPC MORISON S SYRUP N/A M S J Industries SRI LANKA 19-Oct-14 Full 0.1% SODIUM BICARBONATE BP 1% GRIPE MIXTURE (Ceylon) (Pvt) Ltd 10 INFANT CARMINATIVE SYRUP SODIUM GAMMA'S MIXTURE N/A Gamma Pharma- SRI LANKA 16-May- Full BICARBONATE +DIL OIL BP 0.1% GRIPE MIXTURE ceuti cals Pvt Ltd 14 SCHEDULE - I P ART 11 METHYL SALICYLATE 10.2% + MENTHOL 5.44% + FLANIL CREAM George Steuart Biolab Co Ltd THAILAND 24-May- Full I:S EUGENOL 1.36% Health (Pvt) Ltd 14 EC I . (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA -09.10.2019 REPUBLICOFSRILANKA SOCIALIST THE DEMOCRATIC OF . (I)-GAZETTEEXTRAORDINARY 12 METHYL SALICYLATE 6.3% ,MENTHOL 5.7% SALONPAS PATCH Akbar Hisamitsu Phar- JAPAN 06-Apr-15 Full fldgi (^ ,CAMPHAOR 1. 2% & TOCOPHEROL ACETATE Pharmaceuti cals maceuti cals Co (Pvt) Ltd Inc 13 I METHYL SALICYLATE 6.3% ,MENTHOL 5.7% SALONPAS PATCH Akbar Hisamitsu JAPAN 06-Apr-15 Full .eiÜm;%h-2019'10'09 -YS%,xldm%cd;dka;s%liudcjd§ckrcfhaw;súfYI & fPoh ,CAMPHAOR 1. 2% & TOCOPHEROL ACETATE Pharmaceuti cals Pharmaceuti cals (Pvt) Ltd Co Inc 14 METHYL SALICYLATE COMPOUND GEL WINTERPAN GEL N/A Akbar SRI LANKA 11-Apr-14 Full Pharmaceuti cals (Pvt) Ltd 15 ORAL REHYDRATION SALTS BP 21.5G MINERVA ORAL Emar Pharma Unicure INDIA 04-Jun-16 Full POWDER (Pvt) Ltd Ramadies (Pvt) Ltd 16 PARACETAMOL (PAEDIATIC) ORAL SOLUTION B.P PARACETOL LIQUID N/A Gamma SRI LANKA 22-Oct-14 Full 120MG/5ML Pharmaceuti cals Pvt Ltd 17 PARACETAMOL (PAEDRIATIC) ORAL SOLUTION B.P PANADOL SYRUP N/A Glaxo Wellcome SRI LANKA 16-Jun-18 Full 120MG/5ML SYRUP (Ceylon) Ltd 18 PARACETAMOL (PAEDRIATIC) ORAL SUSPENSION B.P ***** ORAL N/A M S J Industries SRI LANKA 08-Feb-18 Two Years 120MG/5ML-Elixir SOLUTION (Ceylon) (Pvt) Ltd 19 PARACETAMOL TABLETS 500MG PANADOL TABLETS N/A Smithkline SRI LANKA 17-Oct-16 Full Beecham (Pvt) Ltd 20 PARACETAMOL TABLETS BP 500MG ACETAMIN TABLETS Citi health Incepta 15-Aug-17 Two Years Imports (Pvt) Ltd Pharmaceuti cals Ltd 21 PARACETAMOL TABLETS BP 500MG MAXMOL TABLETS George Steuart Shefa Healthcare INDIA 18-Jan-14 Full Health (Pvt) Ltd (Pvt) ltd 22 PARACETAMOL TABLETS BP 500MG RAPISOL TABLETS N/A Astron (Pvt) Ltd SRI LANKA 13-Nov-15 Full 23 PEDIATRIC PARACETAMOL ORAL SOLUTION B.P MAXMOL ORAL George Steuart Shefa Healthcare INDIA 10-Jun-15 Full 120MG/5ML SUSPENSION Health (Pvt) Ltd (Pvt) ltd 3 4 SCHEDULE - II (GROUP A) (Contd.) P ART I:S COLUMN-I COLUMN-II COLUMN-III COLUMN-IV COLUMN-V COLUMN- COLUMN- COLUMN-VIII EC VI VII I . (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA -09.10.2019 REPUBLICOFSRILANKA SOCIALIST THE DEMOCRATIC OF . (I)-GAZETTEEXTRAORDINARY fldgi (^ Offi cial Name Brand Name Dosage Form Importer Name Manufacturer Man- Issue Date Reg. Type Country 1 ALBENDAZOLE TABLETS USP 400MG ALBEZIM TABLETS Tabrane Phar- Zim Laboratories INDIA 03-Oct-14 Full I maceuticals Ltd .eiÜm;%h-2019'10'09 -YS%,xldm%cd;dka;s%liudcjd§ckrcfhaw;súfYI & fPoh (Pvt) Ltd 2 ALUM.HYDR. DRIED GEL 300MG+MAG.ALUM. DIGENE MINT TABLETS Sunshine Abbott India Ltd INDIA 01-Jan-18 Provisional SILICATE HYDR 50MG+MAG.HYDR. 25MG FLAVOUR Healthcare lanka SIMETHICONE 25MG Ltd 3 ALUM.HYDR.306MG+MAG.HYDR VISCID ORAL Hemas Pharma- Indoco Remedies INDIA 18-Jan-17 Full 100MG+SIMETHICONE 25MG/5ML SUSPENSION ceuticals (Pvt) India Ltd 4 ALUM.HYDR.GEL 400MG+MAG.HYDR ANTAGTT DS ORAL Ceyoka (Pvt) Ltd Leben INDIA 28-May-14 Full 400MG+SIMETHICONE 50MG/5ML SUSPENSION Laboratories (Pvt) Ltd 5 ALUMINIUM +MAGNESIUM & SIMETHICONE GASTRIL- TABLETS Inter Pharm (Pvt) Inter Pharm (Pvt) SRI LANKA 27-Sep-17 Full TABLETS USP (LEMON Flavour) LEMON Ltd Ltd 6 ALUMINIUM +MAGNESIUM & SIMETHICONE GASTRIL-MINT TABLETS Inter Pharm (Pvt) SRI LANKA 27-Sep-15 Full TABLETS USP (Mint Flavour) Ltd 7 ALUMINIUM 400MG+MAGNESIUM 400MG) ANTAGIT TABLETS Ceyoka (Pvt) Ltd Leben INDIA 02-Mar-14 Full HYDROXIDE+SIMETHICONE 50MG Laboratories (Pvt) Ltd 8 ALUMINIUM HYD.GEL. CATOXYMAG-N ORAL Pharma Raptakos Brett & INDIA 05-Dec-14 Full BP 200MG+MAGNESIUM SUSPENSION Associates Company Ltd HYD.100MG+MAGNESIUM TRISLICATE BP 200MG+SODIUM ALGINATE BP 100MG 9 ALUMINIUM HYDROXIDE ZELLOX -11 ORAL Indoscan (Pvt) Hoe MALAYSIA 28-May-14 Full 8OOMG+MAGNESIUM HYDROXIDE SUSPENSION Ltd Pharmaceuticals 800MG+SIMETHICONE SDN BHD 10 ALUMINIUM HYDROXIDE ANTACIL GEL GEL Sonali & Sudesh Thai Nakorn THAILAND 19-Aug-15 Full 960MG+MAGNESIUM HYDROXIDE 330MG+ Patana Co Ltd SIMETHICONE 60MG 11 ALUMINIUM HYDROXIDE B.P 500MG ***** CHEWABLE State Phar- State SRI LANKA 22-Dec-14 Full TABLETS maceuticals Pharmaceuticals Manufacturer Manufacturer Corporation Corporation SCHEDULE - II (GROUP A) (Contd.) P ART 12 ALUMINIUM HYDROXIDE B.P 500MG **** TABLETS Kamazu (Pvt) B D H Industries INDIA 07-Nov-14 Full I:S Ltd Ltd EC I . (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA -09.10.2019 REPUBLICOFSRILANKA SOCIALIST THE DEMOCRATIC OF . (I)-GAZETTEEXTRAORDINARY 13 ALUMINIUM HYDROXIDE GEL BELCID ORAL George Steuart Biolab Co Ltd THAILAND 15-Oct-18 Full fldgi (^ 918MG+MAGNESIUM HYDROXIDE 300MG+ SUSPENSION Health (Pvt) Ltd SIMETHICONE 60MG 14 ALUMINIUM oxide 570MG+MAGNESIUM ADMAG ORAL Medinex (Pvt) T P Drugs THAILAND 07-Dec-14 Full I hydrox 300MG & SIMETHICONE 60MG ORAL SUSPENSION Ltd Laboratories .eiÜm;%h-2019'10'09 -YS%,xldm%cd;dka;s%liudcjd§ckrcfhaw;súfYI & fPoh SUSPENSION USP 15 ALUMINUM HYDROXIDE DRIED GEL GASTROGEL ORAL Sonali & Sudesh Aspen Pharma AUSTRA- 08-May-16 Full 500MG,MAGNESIUM TRISILICATE 240MG SUSPENSION (Pvt) Ltd LIA +MAGNESIUM HYDROXIDE 240MG IN10ML 16 AQUEOUS CREAM WITH GLYCERINE D-AQUA CREAM Panacea Panacea SRI LANKA 01-Jun-17 Two Years Medicals Medicals 17 AQUEOUS CREAM WITH GLYCERINE D-SOFT CREAM CREAM Panacea Panacea SRI LANKA 25-Apr-17 Two Years Medicals Medicals 18 AQUEOUS CREAM WITH GLYCERINE 2% AQUARIN CREAM Panacea Panacea SRI LANKA 27-Jun-17 Two Years Medicals Medicals 19 ASCORBIC ACID TABLETS BP 100MG C-TABS TABLETS Unical Ceylon Unical Ceylon SRI LANKA 18-Jul-16 Full (Pvt) Ltd (Pvt) Ltd 20 ASCORBIC ACID TABLETS BP 100MG ***** TABLETS Inter Pharm (Pvt) Inter Pharm (Pvt) SRI LANKA 11-May-17 Two Years Ltd Ltd 21 ASCORBIC ACID TABLETS BP 100MG ***** TABLETS M S J Industries M S J Industries SRI LANKA 01-Jan-17 Full (Ceylon) (Pvt) (Ceylon) (Pvt) Ltd Ltd 22 ASCORBIC ACID TABLETS BP 250MG CHEWCE TABLETS Darley Butler & Navana BANGLA- 30-Nov-16 Full Co Ltd Pharmaceuticals DESH Ltd 23 ASCORBIC AICD CHEWABLE TABLETS USP SHINE Vit. C 100 TABLETS Y S P Lanka Y S P Industries / MALAYSIA 30-Apr-17 Full 100MG (Pvt) Ltd SDN BHD l(Pvt) Ltd. 24 ASPIRIN GASTRO RESISTANT TABLETS BP CARVA TABLETS (EN.