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1 Annex IV – Health Itemized list of items (based on DP VII) that may be considered for approval without circulation to the Committee A. PHARMACEUTICALS (FINISHED PRODUCTS) FOR ALL THERAPEUTIC CATEGORIES 1 CARDIOVASCULAR SYSTEM 1A DIGITALIS GLYCOSIDE 1 digoxin tab 62.5 mcg 2 digitoxin tab 100 mcg 3 digoxin tab 125 mcg 4 digoxin tab 250 mcg 5 digoxin PG elixir 50mcg /ml 6 digoxin inj 250 mcg/ml, (2ml amp) 1B DIURETICS 7 amiloride Hcl 5mg + hydrochlorthiazide 50mg tab 8 bumetanide tab 1 mg 9 chlorthalidone tab 50mg 10 ethacrynic acid as sod.salt inj powder for reconstitution 50mg vial 11 frusemide inj 20mg/2ml amp 12 frusemide IV infusion inj 10mg/ml, 25ml amp 13 frusemide tab 40mg 14 frusemide scored tab 500mg 15 frusemide oral solution pead liquid 1mg/1ml 16 frusemide oral solution 4mg/ml 17 frusemide oral solution 8mg/ml 18 hydrochlorothiazide tab 25mg 19 hydrochlorothiazide tab 50mg 20 indapamide tab 2.5mg 21 spironolactone tab 25mg 22 spironolactone tab 100mg 23 Xipamide tab 20mg 1C BETA-ADRENOCEPTER BLOCKING DRUGS 24 acebutolol tab 100mg 25 acebutolol tab 200mg 26 atenolol tab 100mg 27 atenolol tab 50mg or scored tab 28 atenolol tab 25mg 29 Bisoprolol fumarate scored tab 5mg 30 Bisoprolol fumarate scored tab 10mg 31 Carvedilol 6.25mg tab 32 Carvedilol 12.5mg tab 33 Carvedilol 25mg tab 34 Esmolol Hcl IV infusion 10mg/ml (10ml vial) 35 labetalol inj 5mg/ml (20ml amp) 36 labetalol tab 200mg 37 labetalol tab 400mg 38 metoprolol tab 50mg 39 metoprolol tab (s/r) 200mg 40 metoprolol tartrate IV inj 1mg/ml (5ml amp) 41 nadolol tab 80mg 42 oxprenolol Hcl tab 40mg 43 pindolol tab 5mg 2 44 propranolol Hcl slow IV inj 1mg/ml (1ml amp) 45 propranolol Hcl tab 10mg 46 propranolol Hcl tab (or scored tab) 40mg 47 propranolol Hcl cap (s/r) 80mg 48 sotalol tab 40mg 49 sotalol tab 80mg 1D ANTI-ARRHYTHMIC DRUGS 50 amiodarone Hcl inj 50mg/ml (3ml amp) 51 Amiodarone Hcl 200mg tab. 52 bretylium tosylate inj 50mg/ml,( 10ml amp) 53 disopyramide caps 100mg 54 disopyramide tab (s/r) durules 150mg 55 disopyramide tab retard (s/r) 250mg 56 disopyramide inj 10mg/ml, (5ml amp) 57 lignocaine Hcl slow iv infusion inj 20mg/ml, (50ml vial) plain 58 lignocaine Hcl inj 50mg/ml, (2ml amp) Spinal 59 mexiletine Hcl caps 50mg 60 mexiletine Hcl caps 200mg 61 mexiletine Hcl IV,IV infusion inj 25mg/ml, (10ml amp) 62 phenytoin sod.inj 50mg/ml, (5ml amp) 63 practolol inj 2mg/ml, (5ml amp) 64 procainamide Hcl slow IV, IV infusion inj 100mg/ml, (10ml vial) 65 procainamide Hcl tab 500mg 66 procainamide Hcl tab (s/r) 750mg 67 propafenon Hcl tab 150mg 68 quinidine Bisulfate tab (s/r) 250mg (Durules) 69 quinidine Sulphate tab 200mg 70 verapamil Hcl inj 2.5mg/ml, (2ml amp) 71 verapamil Hcl tab 40mg 72 verapamil Hcl tab 80mg 73 verapamil Hcl tab (s/r) 120mg or cap, 1E ANTI-HYPERTENSIVE DRUGS 74 alfuzosin Hcl tab 2.5mg 75 alfuzosin Hcl (S/R) tab 5mg 76 captopril tab 25mg 77 captopril tab 50mg 78 diazoxide tab 50mg 79 doxazosin scored tab 2mg 80 enalapril tab 5mg 81 enalapril tab 10mg 82 enalapril tab 20mg 83 hydralazine Hcl IV infusion inj 20mg per amp 84 hydralazine Hcl tab 25mg 85 hydralazine Hcl tab 50mg 86 Lisinopril tab 5mg 87 Lisinopril tab 10mg 88 Lisinopril tab 20mg 89 Losartan potassium tab 50mg 90 methyldopa inj 50mg/ml, (5ml amp) 91 methyldopa tab 250mg 92 minoxidil tab 5mg 93 minoxidil tab 10mg 94 phenoxybenzamine Hcl caps 10mg 95 phenoxybenzamine Hcl inj 50mg/ml, (2ml amp) 96 phentolamine mesylate inj 10mg/ml, (1ml amp) 97 prazosin Hcl tab 0.5mg 98 prazosin Hcl tab or scored tab 1mg 99 prazosin Hcl tab 2mg 100 prazosin Hcl tab 5mg 3 101 Quinapril Hcl tab 5mg 102 Quinapril Hcl tab 10mg 103 Quinapril Hcl tab 20mg 104 reserpine tab 100mcg 105 sodium nitroprusside i.v.inf 50mg per amp with solvent 106 tolazolin Hcl inj i.v 107 Valsartan cap 160mg 108 Valsartan cap 40mg 109 Valsartan cap 80mg 110 Telmisartan 40mg tab 111 Telmisartan 80mg tab 1F VASODILATORS 112 Amlodipine (as besylate) tab 2.5mg 113 Amlodipine (as besylate) tab 5mg 114 Amlodipine (as besylate) tab 10mg 115 cinnarizine tab 25mg 116 cinnarizine 75mg cap or tab 117 diltiazem Hcl tab 60mg 118 diltiazem Hcl cap (s/r) 90mg 119 diltiazem Hcl cap (s/r) 120mg 120 diltiazem Hcl IV inj or infusion 25mg/vial 121 Felodipine 5mg tab 122 glyceryl trinitrate tab 0. 5mg 123 glyceryl trinitrate inj 5mg/10ml amp. 124 glyceryl trinitrate plaster 5mg 125 glyceryl trinitrate plaster 10mg 126 glyceryl trinitrate plaster 15mg 127 glyceryl trinitrate plaster 25mg 128 glyceryl trinitrate spray 129 glyceryl trinitrate tab (c/r) 2.6mg 130 glyceryl trinitrate tab (c/r) 6.4mg 131 isosorbide dinitrate tab (s/l) 5mg 132 isosorbide dinitrate tab 10mg 133 isosorbide dinitrate tab (s/r) 20mg or cap 134 isosorbide dinitrate tab (s/r) 40mg 135 isosorbide mononitrate tab 10mg 136 isosorbide mononitrate tab or cap 20mg 137 Isosorbide mononitrate 40 mg tab 138 Isosorbide mononitrate 60 mg tab 139 isosorbide mononitrate tab(s/r)25mg or cap 140 isosorbide mononitrate tab(s/r)50mg or cap 141 Nicardipine Hcl IV inj 25mg (solution)/ amp 142 nifedipine caps 5mg 143 nifedipine caps 10mg 144 nifedipine (s/r) caps or tab 10mg 145 nifedipine caps (s/r) 20mg 146 nifedipine caps or tab (s/r) 30mg (24hr) 147 nifedipine caps (s/r) 60mg (24hr) 148 nimodipine tab 30mg 149 nimodipine i.v infusion 200mcg/ml (50ml vial) 150 oxpentiphylline tab 400mg (pentoxifylline) 151 oxpentiphylline tab 600mg (pentoxifylline) 1G SYMPATHOMIMETIC DRUGS 152 dobutamine Hcl inj 250mg per vial 153 dopamine Hcl inj 40mg/ml, (5ml amp) 154 isoprenaline Hcl inj 200 mcg/ml, (5ml amp) 155 isoprenaline Hcl tab (s/r) 20mg 156 metaraminol (as tartrate) inj 10mg/ml, (1ml amp) 157 methoxamine Hcl inj 20mg/ml, (1ml amp) 4 158 phenylephrine Hcl inj 10mg/ml, (1ml amp) 1H SCLEROSING AGENTS 159 ethanolamine oleate inj 5% 160 Sodium tetradecyl sulphate 3% (1ml amp) 1I PHOSPHODIESTERASE INHIBITORS 161 Enoximone inj 5mg/1ml (20ml amp) 2 GASTRO-INTESTINAL SYSTEM 2A ANTACIDS 162 alginic acid 500mg + mag.trisilicate 25mg + dried Al.hydroxide gel 100mg +sod.bicarb.170mg tab 163 Al.hydroxide 215mg +mag.hydroxide 80mg + simethicone 25mg/5ml susp 164 Al.hydroxide 225mg + mag.hydroxide 200mg + simethicone 25mg/5ml susp 165 Al hydroxide dried gel 475 mg tab 166 Aluminium hydroxide 140mg+mag.trisilicate 140mg+mag.carbonate 452mg (or 560mg)+bismuth subcarbonate 73mg +sod.bicarbonate 452mg +malt diastase 28mg+belladona alkaloids 70mcg(or 75mcg) /teaspoonful powder 167 co-dried mag.carb.Al.hydroxide 282 + simethicone 25mg tab 168 colloidal aluminium hydroxide tab 440mg 169 colloidal aluminium hydroxide susp 290mg/5ml, 170 dried Al.hydroxide gel 200mg +mag.hydroxide 200mg+simethicone 25mg tab 171 magnesium trisilicate powder B.P 172 Mg trisilicate 250mg+dried Al.hydroxide gel 120mg tab 173 Mg trisilicate 360mg + Al hydroxide gel 180mg tab 174 Mg trisilicate 200mg + Al hydroxide mag. carb. Co-dried gel 400mg/5ml, susp 175 Mg hydroxide 200mg + Al hydroxide (=dried gel) 225mg/5ml, susp 176 Mg hydroxide 400mg + Al hydroxide gel 400mg tab 177 oxethazaine 10mg + Al.hydroxide 300mg+ Mag.hydroxide 100mg/5ml susp 178 Pancreatin 10mg+vit B1 1mg+atropin sulphate 0.1mg+light mag.carbonate 300mg+mag.trisilicate 50mg+diastase 10mg+calc.carbonate 145mg+sod.bicarbonate 373mg+peppermint oil 0.6mg+light kaolin 50mg+dried aluminium hydroxide gel 50mg/gm powder 179 Sod. alginate 250mg+Sod. bicarb.133.5mg/5ml susp. 2B ANTISPASMODIC 181 camylofin di.Hcl tab 50mg 182 camylofin di.Hcl inj 25mg/ml 183 chlordiazepoxide 5mg + clidinium Br 2.5mg tab 184 isopropamide as iodide 5mg + trifluoperazine as Hcl 1mg tab 185 mepenzolate Br tab 25mg 186 pipenzolate Br tab 5mg 187 pipenzolate methyl Br 4mg + phenobarbital 6mg/ml drop 188 prifinium Br tab 30mg 189 prifinium Br 30mg + Paracetamol 325mg tab. 190 prifinium Br inj 7.5mg /ml 191 propantheline Br tab 15mg 2C DRUGS THAT PROMOTE HEALING OF PEPTIC ULCERS 192 bismuth chelate tab 300mg (Tri-pot. dicitrate bismuthate) 193 bismuth chelate elixir 120mg/5ml 194 cimetidine tab 200mg 195 cimetidine tab 400mg 196 Cimetidine syrup 200mg/5ml 197 cimetidine inj IV.IM ,IV infusion 100mg/ml, (2ml amp) 198 famotidine tab 20mg 199 famotidine tab (or scored tab) 40mg 200 Lansoprazole cap 15mg 201 Lansoprazole cap 30mg 202 omeprazole caps 20mg or omeprazole enteric coated tab 20mg 203 omeprazole caps 40mg or omeprazole enteric coated tab 40mg 204 Olsalazine sod. 250mg cap 205 pirenzepine Hcl tab 25mg 5 206 ranitidine tab 150mg 207 sucralfate tab 1g 208 sucralfate susp 1g/5ml 2D ANTIDIARRHOEAL DRUGS 209 codeine phosphate tab 30 mg 210 diphenoxylate Hcl 2.5mg + atropine sulphate 25mcg tab. 211 Loperamide Hcl tab 2mg 212 Sod.chloride 3.5g+Trisodium citrate dihydrate 2.9g+pot.chloride 1.5g+glucose anhydrous 20g/sachet powder (oral rehydration salts) 213 colotest kit rapid urease test for campylobactor pyloritri specialties Inc 2E TREATMENT OF CHRONIC DIARRHOES 214 mesalazine tab 400mg 215 Mesalazin foam enema 1g 216 Mesalazin rectal supp 1g 217 Mesalazin rectal supp 0.5g 218 sulphasalazine 500mg E.N tab 219 Sod.cromoglycate (oral only) cap 100mg 2F LAXATIVES 220 bisacodyl supp 5mg (child) 221 bisacodyl supp 10mg (adult) 222 bisacodyl tab 5mg 223 bran tab 2g 224 Calcium-salt of purified senna-containing 12g of senna glycoside tab 225 castor oil, 200ml 226 dioctyl Sod. sulphosuccinate tab 100mg (Docusate sod.) 227 dioctyl Sod.
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    ACACETIN ACEBUTOLOL HYDROCHLORIDE ACECLIDINE HYDROCHLORIDE ACEMETACIN ACETAMINOPHEN ACETAMINOSALOL ACETANILIDE ACETARSOL ACETAZOLAMIDE ACETOHYDROXAMIC ACID ACETRIAZOIC ACID ACETYL TYROSINE ETHYL ESTER ACETYLCARNITINE ACETYLCHOLINE ACETYLCYSTEINE ACETYLGLUCOSAMINE ACETYLGLUTAMIC ACID ACETYL-L-LEUCINE ACETYLPHENYLALANINE ACETYLSEROTONIN ACETYLTRYPTOPHAN ACEXAMIC ACID ACIVICIN ACLACINOMYCIN A1 ACONITINE ACRIFLAVINIUM HYDROCHLORIDE ACRISORCIN ACTINONIN ACYCLOVIR ADENOSINE PHOSPHATE ADENOSINE ADRENALINE BITARTRATE AESCULIN AJMALINE AKLAVINE HYDROCHLORIDE ALANYL-dl-LEUCINE ALANYL-dl-PHENYLALANINE ALAPROCLATE ALBENDAZOLE ALBUTEROL ALEXIDINE HYDROCHLORIDE ALLANTOIN ALLOPURINOL ALMOTRIPTAN ALOIN ALPRENOLOL ALTRETAMINE ALVERINE CITRATE AMANTADINE HYDROCHLORIDE AMBROXOL HYDROCHLORIDE AMCINONIDE AMIKACIN SULFATE AMILORIDE HYDROCHLORIDE 3-AMINOBENZAMIDE gamma-AMINOBUTYRIC ACID AMINOCAPROIC ACID N- (2-AMINOETHYL)-4-CHLOROBENZAMIDE (RO-16-6491) AMINOGLUTETHIMIDE AMINOHIPPURIC ACID AMINOHYDROXYBUTYRIC ACID AMINOLEVULINIC ACID HYDROCHLORIDE AMINOPHENAZONE 3-AMINOPROPANESULPHONIC ACID AMINOPYRIDINE 9-AMINO-1,2,3,4-TETRAHYDROACRIDINE HYDROCHLORIDE AMINOTHIAZOLE AMIODARONE HYDROCHLORIDE AMIPRILOSE AMITRIPTYLINE HYDROCHLORIDE AMLODIPINE BESYLATE AMODIAQUINE DIHYDROCHLORIDE AMOXEPINE AMOXICILLIN AMPICILLIN SODIUM AMPROLIUM AMRINONE AMYGDALIN ANABASAMINE HYDROCHLORIDE ANABASINE HYDROCHLORIDE ANCITABINE HYDROCHLORIDE ANDROSTERONE SODIUM SULFATE ANIRACETAM ANISINDIONE ANISODAMINE ANISOMYCIN ANTAZOLINE PHOSPHATE ANTHRALIN ANTIMYCIN A (A1 shown) ANTIPYRINE APHYLLIC