greenbook4

¬“µ“â π‡™ÕÈ◊ √“ - Griseofulvin Tablet - Miconazole nitrate Cream - Nystatin oral Suspension - Nystatin vaginal Suppository °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 19091

¬“µ“â π‡™Õ◊È √“ Griseofulvin Tablet °√‘ ´‚’ Õø≈«Ÿ ‘π ™π‘¥‡¡Á¥ À«— ¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µ≈à –Àπ«à ¬ (Content uniformity) - Loss on drying ººŸâ ≈‘µ∑Ë’ºà“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈◊Õ° √“¬™◊Ëպ⺟ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‚√ßß“π‡¿ —™°√√¡ ·Õµ·≈πµ°‘ 1A 1370/29 Grivin Atlantic Laboratories Corp. Ltd Mycoxyl-500 ∫“ß°Õ°·≈∫ ·Õπ¥å §Õ ‡¡µ°‘ 1A 257/38 Bangkok Lab & Cosmetic Co., Ltd. Mycovin 500 ™ÿ¡™π‡¿ ™— °√√¡ 1A 341/34 Community Pharmacy Public Co., Ltd. 1020 GREEN BOOK 4

¬“µ“â π‡™ÈÕ◊ √“ √“¬™Õ◊Ë ºŸâº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‡¬π‡πÕ√√å “≈ ¥√°—Í ‡Œ“ å 1A 1235/27 Grifulvin 500 General Drugs House Co., Ltd. 1A 1236/27 Grifulvin 125 ‡¡¥‘´π’ ‚ª√¥—° å 1A 1264/41 Aofen 500 Medicine Products Co., Ltd. 𑫉≈øá ø“√å¡“ 1A 718/39 Newfulvin-500 New Life Pharma Co., Ltd. ø“√å¡“ ´—ææ≈“¬ 1A 198/33 Grevin Pharma supply Co., Ltd. ø“√å¡“ —πµå ≈“∫Õ√“∑Õ√ ’ å 1A 460/31 Trivanex 500 Pharmasant Laboratories Co., Ltd æÕπ¥å ‡§¡’§Õ≈ (ª√–‡∑»‰∑¬) 1A 144/36 Griseofulvine Pondûs Chemical (Thailand) R.O.P. ∑’.·¡π ø“√¡å “ 1A 464/44 Griseofulvin Tablet T.Man Pharma Ltd. Part. 1A 690/39 Griseofulvin Tablet ¬‚Ÿ ∑‡ªô¬ï π 1A 457/40 Griseo-Med 500 Utopian Co., Ltd. 1A 1014/29 Fuga FP 500 ∫Ÿ√æ“‚Õ ∂ 1A 635/32 Fulvin 500 Fulvin 125 Burapha dispensary Co., Ltd. 1A 636/32 ‚¡‡¥Õ√πå ·¡πŸ 1A 1166/28 Griso-500 Modern Manu. Ltd. °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 1013

¬“µâ“π‡™È◊Õ√“ Miconazole nitrate Cream ‰¡‚§π“‚´≈ ‰π‡µ√∑ ™π¥‘ §√’¡ À—«¢Õâ µ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active ingredient) ºŸºâ ≈‘µ∑ºË’ à“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈◊Õ° √“¬™◊ËÕºŸâº≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name Õߧ尓√‡¿ —™°√√¡ - Miconazole Government Pharm. Organization 1042 GREEN BOOK 4

¬“µ“â π‡™◊ÕÈ √“ Nystatin oral Suspension ‰π ‡µµπ‘ ™π¥‘ πÈ”·¢«πµ–°Õπ ”À√—∫√—∫ª√–∑“π À—«¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§—≠ (Active ingredient) - §“à §«“¡‡ªìπ°√¥ - ‡∫  (pH) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈◊Õ° √“¬™Õ◊Ë ºâºŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name Õ‘π‡µÕ√å‰∑¬ ø“√å¡“´Ÿµ‘§Õ≈ 1A 153/41 Mycostatin Interthai Pharma. Manu. Ltd. 1A 269/39 Tystatin ∑.’ ‚Õ. ø“√å¡“ T.O. Pharma Co., Ltd. °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 1053

¬“µ“â π‡™◊ÈÕ√“ Nystatin vaginal Suppository ‰π ‡µµ‘π ™π¥‘ ‡¡Á¥‡Àπ∫Á ™àÕߧ≈Õ¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active ingredient) - §“à ‡∫ˬ’ ߇∫π®“°π”È Àπ—°‡©≈’¬Ë (Weight variation) - °“√·µ°°√–®“¬µ«— ¢Õ߇¡Á¥¬“ (Disintegration) ºŸâº≈‘µ∑Ë’º“à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™◊Ëպ⟺≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name §Õ𵑇ππ‡µ≈‘ ø“√å¡ 2A 3/48 Gynecon-T Continental Pharma Co.,Ltd. 2A 979/27 Gynecon 2A 62/39 Gynoco ∑.’ ‚Õ. ø“√å¡“ T.O. Pharma Co., Ltd. 2A 678/27 Nagena ‡Õ™.‡§.ø“√å¡“´Ÿµ‘§Õ≈ 2A 687/30 Nystin H.K Pharmaceutical Co.,Ltd. 2A 799/30 V.G.Med ‚ª≈ø‘ “√¡å Polipharm Co., Ltd ∑’.·¡π ø“√å¡“ T.Man Pharma Ltd. Part. 1064 GREEN BOOK 4

¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ - Carbamazepine Tablet - Carbamazepine control releaseTablet - Chlordiazepoxide Capsule - Chlordiazepoxide Tablet - Chlorpromazine hydrochloride Injection - Chlorpromazine hydrochloride film coated Tablet - Fluphenazine decanoate Injection - Imipramine hydrochloride sugar coated Tablet - Perphenazine film coated Tablet - Phenytoin sodium Capsule - Phenytoin sodium Injection - Phenytoin sodium Tablet - Trifluoperazine film coated Tablet °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 1057

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Carbamazepine Tablet §“√∫å “¡“´æ’ 𒠙𥑠‡¡Á¥ À—«¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§—≠ (Active ingredient) - §à“‡∫Ë’¬ß‡∫π®“°πÈ”Àπ°— ‡©≈’ˬ (Weight variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ºŸºâ ≈‘µ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‚π«“√µå ‘  1C 284/42 Tegretol 200 Novartis Fama S.P.A. 1A 535/28 Antafit ‚ª≈ø‘ “√¡å Polipharm Co., Ltd 1A 452/38 Mapezine  ¬“¡‡¿ ™— Siam Bheasach Co.,Ltd. 1086 GREEN BOOK 4

¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ Carbamazepine control releaseTablet §“√å∫“¡“´æ’ 𒠙𥑠‡¡¥Á À«— ¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®π‡å Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active ingredient) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√‘¡“≥µ—«¬“„π·µà≈–Àπ૬ (Content uniformity) ººŸâ ≈‘µ∑’ºË “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ËÕ◊ ºŸâº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‚π«“√嵑  1C 266/42 Tegretol CR 200 Novartis Fama S.P.A. °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 1097

¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ Chlordiazepoxide Capsule §≈Õ‰¥‡Õ´’æÁÕ°‰´¥å ™π¥‘ ·§ª´≈Ÿ À«— ¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active ingredient) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√‘¡“≥µ«— ¬“„π·µ≈à –Àπ૬ (Content uniformity) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - °“√µ√«® Õ∫ Related substances ºâŸº≈µ‘ ∑’˺à“π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈◊Õ° √“¬™ËÕ◊ ºâŸº≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‚√ßß“π‡¿ —™°√√¡ ·Õµ·≈πµ°‘ 1A 037/42 Benpine Atlantic Laboratories Corp. Ltd 11008 GREEN BOOK 4

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Chlordiazepoxide Tablet §≈Õ‰¥‡Õ´æ’ ÁÕ°‰´¥å ™π¥‘ ‡¡Á¥ À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√‘¡“≥µ«— ¬“„π·µà≈–Àπ«à ¬ (Content uniformity) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - °“√µ√«® Õ∫ Related substances ºŸâº≈‘µ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™Ë◊ÕºŸâº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ø“√å¡“ —πµå ≈“∫Õ√“∑Õ√ ’ å 1A 40/42 Cozep 25 mg Pharmasant Laboratories Co.,Ltd. °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 11091

¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ Chlorpromazine hydrochloride Injection §≈Õ‚æ√¡“´’π ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ©’¥ À—«¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active ingredient) - §“à §«“¡‡ªπì °√¥ - ‡∫  (pH) - °“√µ√«® Õ∫ Related substances ºŸâº≈µ‘ ∑Ë’ºà“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™◊ËÕºŸºâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name Õߧ尓√‡¿ —™°√√¡ 1A 222/44 Chlorpromazine Government Pharm. Organization 1120 GREEN BOOK 4

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Chlorpromazine hydrochloride film coated Tablet §≈Õ‚æ√¡“´π’ ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ‡¡¥Á ‡§≈Õ◊ ∫ø≈î å¡ À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active ingredient) - §à“‡∫¬Ë’ ߇∫π®“°π”È Àπ°— ‡©≈’¬Ë (Weight variation) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - °“√µ√«® Õ∫ Related substances ººâŸ ≈µ‘ ∑Ë’ºà“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈◊Õ° √“¬™ËÕ◊ ºâŸº≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ø“√å¡“ π— µå ≈“∫Õ√“∑Õ√ ’ å 1A 179/43 Chlorpromazine 25 mg Pharmasant Laboratories Co.,Ltd 1A 181/44 Pogetol 50 mg 1A 180/44 Pogetol 100 mg Õߧ尓√‡¿ ™— °√√¡ 1A 200/44 Chlorpromazine Government Pharm. Organization hydrochloride 100 mg °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 1113

¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ Fluphenazine decanoate Injection ø≈Ÿ‡øππ“´π’ ‡¥§“‚π‡Õ∑ ™π¥‘ ©’¥ À«— ¢Õâ µ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - Chromatographic purity ºŸºâ ≈µ‘ ∑º’Ë à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ºŸâº≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‚¡‡¥Õ√πå ·¡πŸ 1A 2529/28 Fendec Modern Manu. Ltd. 1142 GREEN BOOK 4

¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ Imipramine hydrochloride sugar coated Tablet Õ¡‘ æ‘ √“¡π’ ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ‡¡¥Á ‡§≈Õ◊ ∫π”È µ“≈ À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µ≈à –Àπ૬ (Content uniformity) ºâºŸ ≈µ‘ ∑˺’ “à π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈◊Õ° √“¬™ËÕ◊ ºâŸº≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ø“√¡å “ —πµå ≈“∫Õ√“∑Õ√ ’ å 1A 179/37 Celamine Pharmasant Laboratories Co., Ltd. Topramine Sermonil ¬Ÿ‚∑‡ªï¬ô π 1A 2229/28 Utopian Co., Ltd. 1A 659/28 °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 1135

¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ Perphenazine film coated Tablet ‡æÕ√øå ïπ“´π’ ™π¥‘ ‡¡¥Á ‡§≈◊Õ∫øî≈¡å À—«¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®π‡å Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active ingredient) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µà≈–Àπ૬ (Content uniformity) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ºâŸº≈‘µ∑’˺à“π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈Õ◊ ° √“¬™◊Ëպ⺟ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ø“√¡å “ —πµå ≈“∫Õ√“∑Õ√’ å 1A 20/35 Porazine 2 Porazine 4 Pharmasant Laboratories Co., Ltd 1A 327/35 Porazine 8 1A 299/35 1164 GREEN BOOK 4

¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ Phenytoin sodium Capsule ‡øππ∑’ Õ¬ ‚´‡¥’¬¡ ™π¥‘ ·§ª´≈Ÿ À«— ¢Õâ µ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√‘¡“≥µ—«¬“„π·µ≈à –Àπ૬ (Content uniformity) ºâŸº≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈◊Õ° √“¬™Õ◊Ë ºŸºâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‚√ßß“π‡¿ —™°√√¡ ·Õµ·≈πµ°‘ 1A 1657/27 Ditoin Atlantic Laboratories Corp. Ltd. Dilantin ‰ø‡´Õ√å 1C 38/47 Pfizer Co.,Ltd. °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 1175

¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ Phenytoin sodium Injection ‡øππ∑’ Õ¬‚´‡¥¬’ ¡ ™π¥‘ ©’¥ À«— ¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active ingredient) - §à“§«“¡‡ªìπ°√¥ - ‡∫  (pH) - °“√µ√«® Õ∫ “√°àÕ‰¢â (Bacterial Endotoxin Test, LAL) - °“√∑¥ Õ∫ Particulate Matter - °“√∑¥ Õ∫ Volume in container ºŸºâ ≈µ‘ ∑˺’ à“π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈◊Õ° √“¬™ÕË◊ ºâŸº≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name √Ÿ∫‚‘ Õ ·≈∫Õ√“∑Õ√Ë’ å 1C 170/42 Fenitoina Rubio Dilantin ready-mixed Laboratories Rubio,S.A.Racelon Utoin Parkedale Pharmaceuticals, Inc. 1C 125/42 (ºâ·Ÿ ∑π®”Àπà“¬ : «Õ‡πÕ√å ·≈¡‡∫‘∑ (‰∑¬)) ¬Ÿ‡¡¥â“ 1A 139/47 Umeda Co., Ltd 1186 GREEN BOOK 4

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Phenytoin sodium Tablet ‡øππ∑’ Õ¬‚´‡¥’¬¡ ™π¥‘ ‡¡Á¥ À«— ¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√‘¡“≥µ«— ¬“„π·µ≈à –Àπ૬ (Content uniformity) ºâºŸ ≈µ‘ ∑ºË’ à“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™◊ÕË ºŸâº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‚Õ≈§‘ (ª√–‡∑»‰∑¬) 1A 36/40 Dilantin Infatab Olic (Thailand) Ltd. °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 1179

¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ Trifluoperazine film coated Tablet ‰µ√ø≈Ÿ‚Õ‡æÕ√“´π’ ™π¥‘ ‡¡¥Á ‡§≈Õ◊ ∫ø≈î ¡å À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√‘¡“≥µ«— ¬“„π·µ≈à –Àπ«à ¬ (Content uniformity) ººŸâ ≈µ‘ ∑’ºË à“π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈Õ◊ ° √“¬™ÕË◊ ºâºŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name Õߧ尓√‡¿ ™— °√√¡ 1A92/47 Triflazine Government Pharm. Organization 12108 GREEN BOOK 4

¬“ŒÕ√å‚¡π - Levonorgestrel Tablet - Medroxyprogesterone acetate Tablet - Norethisterone Tablet °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 12119

¬“ŒÕ√å‚¡π Levonorgestrel Tablet ‡≈‚«πÕ√‡å ® ‡∑√≈ ™π‘¥‡¡Á¥ À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active ingredient) - °“√·µ°°√–®“¬µ«— ¢Õ߇¡Á¥¬“ (Disintegration) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µ≈à –Àπ«à ¬ (Content uniformity) - °“√µ√«® Õ∫ Related substances ºâºŸ ≈‘µ∑’˺“à π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈◊Õ° √“¬™◊Ëպ⺟ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name Chemical Works of Gedeon 1B 50/41 Postinor (º·Ÿâ ∑π®”Àπ“à ¬ : ∫√…‘ ∑— ¬πŸ ´‘ π— ®”°¥— ) 1220 GREEN BOOK 4

¬“ŒÕ√å‚¡π Medroxyprogesterone acetate Tablet ‡¡¥ÕÁ °´’‚Ë æ√‡® ‡µÕ‚√π Õ´’‡µ∑ ™π¥‘ ‡¡¥Á À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√‘¡“≥µ—«¬“„π·µ≈à –Àπ«à ¬ (Content uniformity) ººŸâ ≈‘µ∑’˺“à π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈◊Õ° √“¬™ÕË◊ ºâºŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‚√ßß“π‡¿ ™— °√√¡·À≈¡∑Õß°“√·æ∑¬å 1A 88/41 Manodepo 10 March Pharmaceutical Co.,Ltd. Provera 2.5 ø“√¡å “‡´¬’ ·Õπ¥å Õæ— ®ÕÀπå 1C 36/44 Provera 10 Provera 10 Pharmacia & Upjohn Caribe, Inc. 1C 1003/28 ‰ø‡´Õ√å 1C 168/48 Pfizer Pharmaceuticals °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 1213

¬“ŒÕ√å‚¡π Norethisterone Tablet πÕ√‡å Õ∑∑‘ ‡∑Õ‚√π ™π¥‘ ‡¡Á¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ πå‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - °“√·µ°°√–®“¬µ—«¢Õ߇¡Á¥¬“ (Disintegration) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√‘¡“≥µ—«¬“„π·µ≈à –Àπ૬ (Content uniformity) ºŸºâ ≈‘µ∑˺’ à“π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈Õ◊ ° √“¬™ËÕ◊ ºâºŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ·Õ§¥Õπ 1A 967/30 Norterone Acdhon Co.,Ltd. Primolut N Sunolut ‡™Õ√Ë‘ß ª√–‡∑»Õ‘π‚¥π‡’ ´¬’ 1C 386/40 P.T.Schering Indonesia Steron Sunward Pharmaceutical Pte.Ltd 1C 18/48 (º·Ÿâ ∑π®”Àπ“à ¬ :  .‡®√≠‘ ‡¿ ™— ‡∑√¥¥‘ßÈ ª√–‡∑»‰∑¬) West-Coast Pharmaceutical Work 1C 294/33 (º·âŸ ∑π®”Àπà“¬ : ∫√…‘ ∑— ¬‡Ÿ π¬’ π‡¡¥¥§‘ Õ≈ ª√–‡∑»‰∑¬) 1242 GREEN BOOK 4

¬“√°— …“‚√§‡√◊ÈÕπ - Clofazimine Capsule - Dapsone Tablet °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 1253

¬“√°— …“‚√§‡√Õ◊È π Clofazimine Capsule ‚§≈ø“´‘¡π’ ™π‘¥·§ª´≈Ÿ À—«¢Õâ µ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §“à ‡∫Ë’¬ß‡∫π®“°π”È Àπ°— ‡©≈Ë’¬ (Weight variation) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) ººŸâ ≈‘µ∑’ºË “à π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈Õ◊ ° √“¬™Õ◊Ë ºŸâº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name æÕπ¥å ‡§¡’§Õ≈ (ª√–‡∑»‰∑¬) 1A 848/41 Lamcoin Pondûs Chemical (Thailand) R.O.P. 1264 GREEN BOOK 4

¬“√°— …“‚√§‡√◊ÕÈ π Dapsone Tablet ·¥ª‚´π ™π‘¥‡¡¥Á À—«¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µ≈à –Àπ«à ¬ (Content uniformity) ººâŸ ≈‘µ∑’˺à“π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈Õ◊ ° √“¬™Õ◊Ë ºâŸº≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name æÕπ¥å ‡§¡’§Õ≈ (ª√–‡∑»‰∑¬) 1A 1047/27 Dopsan-100 Pondûs Chemical (Thailand) R.O.P. °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 1275

¬“µâ“πŒ’ µ“¡’π - Chlorpheniramine maleate Syrup - Chlorpheniramine maleate Tablet 1286 GREEN BOOK 4

¬“µ“â πŒ’ µ“¡π’ Chlorpheniramine maleate Syrup §≈Õ‡øπ‘√“¡’π ¡“≈’‡Õµ ™π‘¥π”È ‡™ÕË◊ ¡ À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §à“§«“¡‡ªìπ°√¥ - ‡∫  (pH) - ª√¡‘ “≥‡™ÕÈ◊ ®ÿ≈‘π∑√’¬å (Microbial Limit) ºŸºâ ≈‘µ∑’˺“à π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈◊Õ° √“¬™Ë◊ÕººâŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‡§.∫’.ø“√å¡“´µŸ §‘ Õ≈ 1A 14/46 K.B. Ramine K.B. Pharmaceutical. Co.,Ltd. ø“√å¡“ —πµå ≈“∫Õ√“∑Õ√’ å 1A 175/31 Histatapp Pharmasant Laboratories Co., Ltd ∑.’ ‚Õ. ‡§¡§‘ —≈ å 1A 314/43 Chlorpheniramine T.O. Chemicals (1979) Co., Ltd. 𑫉≈øá ø“√å¡“ 1A 315/33 Chlorphen New Life Pharma Co., Ltd. Õߧ°å “√‡¿ ™— °√√¡ 1A 854/43 Chlorpheniramine Government Pharm. Organization maleate °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 1279

¬“µâ“πŒ’ µ“¡’π Chlorpheniramine maleate Tablet, 4 mg §≈Õ‡øπ‘√“¡’π ¡“≈’‡Õµ ™π¥‘ ‡¡Á¥ À—«¢Õâ µ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µà≈–Àπ«à ¬ (Content uniformity) - °“√µ√«® Õ∫ Related substances ºâºŸ ≈µ‘ ∑ºË’ à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººâŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name Õߧ°å “√‡¿ —™°√√¡ 1A 723/43 Chlorpheniramine Government Pharm. Organization maleate 𑫉≈øá ø“√å¡“ 1A 291/33 Chlorphen New Life Pharma Co., Ltd. ø“√¡å “ —πµå ≈“∫Õ√“∑Õ√’ å 1A 1243/30 Histatab Pharmasant Laboratories Co.,Ltd. 13208 GREEN BOOK 4

¬“√°— …“‚√§æ“√°å π‘  π— - Levodopa and Carbidopa monohydrate Tablet - Trihexyphenidyl hydrochloride Tablet °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 13291

¬“√—°…“‚√§æ“√å°‘π —π Levodopa and Carbidopa monohydrate Tablet ‡≈‚«‚¥ª“ ·≈– §“√∫å ‘‚¥ª“ ‚¡‚π‰Œ‡¥√∑ ™π¥‘ ‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §“à ‡∫¬’Ë ß‡∫π®“°πÈ”Àπ°— ‡©≈¬Ë’ (Weight variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ºâºŸ ≈‘µ∑º’Ë à“π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈Õ◊ ° √“¬™ÕË◊ ºâºŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‡Õ¡Á ·Õπ¥å ‡Õ™ ·¡πŸ·ø§‡®Õ√Ë‘ß 2A 85/48 Sinemet (100/25) M & H Manufacturing Co., Ltd. 2A 140/48 Sinemet (250/25) Syndopa 275 Sun Pharmaceutical Ind.Ltd.,India 2C 16/38 (ºŸâ·∑π®”Àπà“¬ : ø“√å¡“·≈π¥å Levomet (100/25) (1982)) Levomet (250/25) ¬Ÿπ‘´π— ≈“∫Õ√“∑Õ√ Ë’ å 2A 286/41 Unison Laboratories Co.Ltd. 2A 46/38 1320 GREEN BOOK 4

¬“√—°…“‚√§æ“√å°‘π —π Trihexyphenidyl hydrochloride Tablet ‰µ√‡Œ°´’ˇøπ𥑠‘≈ ‰Œ‚¥√§≈Õ‰√¥å ™π‘¥‡¡Á¥ À—«¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ πå‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µ≈à –Àπ૬ (Content uniformity) ºŸâº≈‘µ∑º’Ë à“π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈◊Õ° √“¬™◊ËÕºŸâº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‚√ßß“π‡¿ ™— °√√¡ ·Õµ·≈πµ°‘ 1A 116/27 ACA 2 mg Atlantic Laboratories Corp. Ltd. 1A 1564/28 ACA 5 mg Õߧ°å “√‡¿ —™°√√¡ 1A 27/46 Benzhexol 2 mg Benzhexol 5 mg Government Pharm. Organization 1A 28/46 Pozhexol ø“√å¡“ —πµå ≈“∫Õ√“∑Õ√’ å 1A 244/32 Pozhexol 5 Pharmasant Laboratories Co.,Ltd. 1A 839/42 Tridyl 2 mg Tridyl 5 mg ¬Ÿ‚∑‡ªô¬ï π 1A 1390/28 Acamed Utopian Co., Ltd. 1A 1482/28 1A 909/31 °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 1331

¬“¶“à ÀπÕπ欓∏‘ - Diethylcarbamazine citrate Tablet - Niclosamide Tablet 1342 GREEN BOOK 4

¬“¶à“ÀπÕπ欓∏‘ Diethylcarbamazine citrate Tablet ‰¥‡Õ∑∏≈‘ §“√å∫“¡“´’π ´‘‡∑√∑ ™π¥‘ ‡¡Á¥ À—«¢Õâ µ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ ‘ ®Ÿ πå‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§—≠ (Active ingredient) - §“à ‡∫’ˬ߇∫π®“°πÈ”Àπ°— ‡©≈¬Ë’ (Weight variation) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - °“√µ√«® Õ∫ Related substances ºŸâº≈‘µ∑’˺à“π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈Õ◊ ° √“¬™ËÕ◊ ººŸâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name æÕπ¥å ‡§¡’§Õ≈ (ª√–‡∑»‰∑¬) 1A 900/40 Filadec Pondûs Chemical (Thailand) R.O.P. °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 1353

¬“¶“à ÀπÕπ欓∏‘ Niclosamide Tablet 𑂧≈´“‰¡§å ™π¥‘ ‡¡Á¥ À«— ¢âÕµ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - §à“‡∫’ˬ߇∫π®“°π”È Àπ°— ‡©≈ˬ’ (Weight variation) - °“√µ√«® Õ∫ Related substances - µ√«® 2-Chloro-4-nitroaniline ºŸâº≈‘µ∑Ë’º“à π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈Õ◊ ° √“¬™ËÕ◊ ºŸâº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ¡≈‘ ≈‡‘ ¡¥ 1A 292/46 Niclosamide Millimed Co., Ltd 1A 301/31 Niclosamide ∑’.·¡π ø“√¡å “ T.Man Pharma Ltd. Part. 1364 GREEN BOOK 4

¬“ª√–‡¿∑ÕπË◊ Ê - Atropine sulfate Injection - Baclofen Tablet - Dextromethorphan hydrobromide Syrup - Dimenhydrinate Injection - Dimenhydrinate Syrup - Dimenhydrinate Tablet - Thiamazole Tablet °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 1357

¬“ª√–‡¿∑ÕËπ◊ Ê Atropine sulfate Injection Õ‚∑√æ’π ´≈— ‡øµ ™π‘¥©’¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active ingredient) - §à“§«“¡‡ªπì °√¥ - ‡∫  (pH) - °“√µ√«® Õ∫§«“¡ª√“»®“°‡™◊ÈÕ (Sterility Test) ºâºŸ ≈‘µ∑˺’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººâŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‡Õ.‡ÕπÁ .∫’. ·≈∫∫Õ√“∑Õ√ Ë’ å 1A 143/34 Atropine sulfate A.N.B.Laboratories Co., Ltd. Atropine sulfate Õߧ°å “√‡¿ —™°√√¡ 1A 680/43 Government Pharm. Organization 1386 GREEN BOOK 4

¬“ª√–‡¿∑ÕπË◊ Ê Dextromethorphan hydrobromide Syrup ‡¥ä°´å‚∑√‡¡∑√Õ·øπ ‰Œ‚¥√‚∫√‰¡¥å ™π¥‘ πÈ”‡™◊ËÕ¡ À—«¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active ingredient) ºâºŸ ≈‘µ∑˺’ à“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™ËÕ◊ ººâŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‚Õ ∂ Õπ‘ ‡µÕ√·å ≈∫ 1A 206/36 A-Tussin Osoth Inter Lab. Co.,Ltd. 1A 1055/41 Dextro-5 ‡¡¥´‘ π’ ‚ª√¥°—  å 1A 239/36 Dextromethorphan Medicine Products Co., Ltd. 1A 409/36 Dex Cough  À·æ∑¬å‡¿ —™ The Medic Pharma Co., Ltd. °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 1397

¬“ª√–‡¿∑Õ◊ËπÊ Baclofen Tablet, 10 mg ∫“‚§≈‡øπ ™π¥‘ ‡¡¥Á À«— ¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§—≠ (Active ingredient) - §«“¡ ¡”Ë ‡ ¡Õ¢Õßπ”È Àπ°— ·µ≈à –Àπ«à ¬ (Uniformity of Weight) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - ª√¡‘ “≥ Lactam ºŸºâ ≈µ‘ ∑Ë’ºà“π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈◊Õ° √“¬™◊ËÕººâŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‚π«“√µå ’  ø“¡“, ª√–‡∑»Õ‘µ“≈’ 1C 291/42 Lioresal Novartis Fama S.P.A.,Italy 1A412/48 Fenisal ·¡§‚§√ø“√å Macrophar Company Limited 1A 759/43 Baclosal ‡ÕÁ¡ ·Õπ¥å ‡Õ™ ·¡πŸ·ø§‡®Õ√Ë‘ß M&H Manufacturing Co.,Ltd. 14308 GREEN BOOK 4

¬“ª√–‡¿∑Õ◊ËπÊ √“¬™◊ÕË ºŸâº≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‡¿ —™°√√¡»√’ª√– ∑‘ ∏‘Ï 1A 403/48 Liobac Sriprasit Pharma Co,Ltd. Baclofen Àâ“ߢ“¬¬“ Õ—ß°ƒ…µ√“ߟ 1A 246/44 The British Dispensary (LP) Co.,Ltd °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 13419

¬“ª√–‡¿∑ÕËπ◊ Ê Dimenhydrinate Injection ‰¥‡¡π‰Œ¥√‘‡π∑ ™π¥‘ ©’¥ À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§≠— (Active ingredient) - §à“§«“¡‡ªìπ°√¥ - ‡∫  (pH) - °“√µ√«® Õ∫§«“¡ª√“»®“°‡™Õ◊È (Sterility Test) - °“√µ√«® Õ∫ “√°Õà ‰¢â (Bacterial Endotoxin Test, LAL) - µ√«®ª√¡‘ “≥ 8-chlorotheophylline ººâŸ ≈µ‘ ∑º’Ë à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈◊Õ° √“¬™◊ÕË ºâŸº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ¬‡Ÿ π¬’ π ¥√°—  å ≈“∫Õ√“∑Õ√ ’ å 1A 141/35 Motivan Union Drug Laboratories 1A 62/35 Dimeno ¡≈‘ “‚π Milano Lab Ltd,Part. 1A 583/36 Dimovit ·Õ≈ ∫’ ‡Õ  ≈“∫Õ√“∑Õ√’ å 1A 742/41 Dimonate L.B.S. Laboratory Ltd., Part ¬Ÿ‚∑‡ªïô¬π Utopian Co., Ltd. 1420 GREEN BOOK 4

¬“ª√–‡¿∑Õ◊ËπÊ Dimenhydrinate Syrup ‰¥‡¡π‰Œ¥√‡‘ π∑ ™π‘¥¬“π”È ‡™◊ËÕ¡ À—«¢Õâ µ√«® Õ∫§ÿ≥¿“æ - °“√µ√«®æ‘ Ÿ®π‡å Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active ingredient) - µ√«®ª√‘¡“≥ 8-chlorotheophylline ººâŸ ≈µ‘ ∑ºË’ à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈◊Õ° √“¬™◊ÕË ºâºŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ¡≈‘ “‚π 1A 1335/30 Dimeno Milano Lab Ltd,Part. °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 1413

¬“ª√–‡¿∑ÕËπ◊ Ê Dimenhydrinate Tablet ‰¥‡¡π‰Œ¥√‡‘ π∑ ™π‘¥‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active ingredient) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√‘¡“≥µ—«¬“„π·µ≈à –Àπ«à ¬ (Content uniformity) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - µ√«®ª√¡‘ “≥ 8-chlorotheophylline ºŸâº≈µ‘ ∑Ë’ºà“π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈◊Õ° √“¬™Ë◊պ⟺≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ∫’.‡Õ≈.ŒÈ—«. 1A 1719/29 Denim B.L. HUA Co.,Ltd. 1A 1990/28 Dimonate ¬‚Ÿ ∑‡ªôï¬π Utopian Co., Ltd. 1A 1689/29 Dimenhydrinate ∑’.·¡π. ø“√å¡“ T.MAN Pharma Ltd.,Part. 1442 GREEN BOOK 4

¬“ª√–‡¿∑Õ◊ËπÊ √“¬™◊ËÕººâŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name π«‘ ‰≈øá ø“√å¡“ 1A 663/38 Dimenhydrinate New Life Pharma Co., Ltd. ø“√¡å “ π— µå ≈“∫Õ√“∑Õ√ ’ å 1A 278/30 Pharmamin Pharmasant Laboratories Co., Ltd ‡Õ™.‡§.ø“√å¡“´µŸ ‘§Õ≈ 1A 193/26 Dimenhydrinate H.K Pharmaceutical Co.,Ltd. ‡¡¥´‘ π’ ‚ª√¥°—  å 1A 63/34 Dimenhydrinate Medicine Products Co., Ltd. Õߧ°å “√‡¿ ™— °√√¡ 1A 77/43 Dimenhydrinate 50 mg Government Pharm. Organization °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 1453

¬“ª√–‡¿∑Õπ◊Ë Ê Thiamazole Tablet ‰∑Õ“¡“‚´≈ ™π¥‘ ‡¡¥Á À—«¢âÕµ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®π‡å Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µà≈–Àπ«à ¬ (Content uniformity) ºŸâº≈‘µ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈◊Õ° √“¬™◊Ëպ⟺≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‡¿ —™°√√¡»√’ª√– ‘∑∏‘Ï 1A 85/48 Timazol Sriprasit Pharma Co,Ltd. Tepazole Interphil laboratories/ Ely lily 1C 19/49 (ºâ·Ÿ ∑π®”Àπ“à ¬ : ¥’∑·Œ≈å¡) Thiamazole Yung shin pharmaceutical Ind. IC 550/28 Co.Ltd. (ºâ·Ÿ ∑π®”Àπà“¬ : ø“√åÕ ’ µå ø“√¡å “´Ÿµ§‘ Õ≈) 1464 GREEN BOOK 4

¿“§ºπ«° ¿“§ºπ«° ¿“§ºπ«° °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 147

√“¬™ËÕ◊ Àπ«à ¬ß“π·≈–ºŸâ√«à ¡¥”‡π‘π°“√ ªßï ∫ª√–¡“≥ 2550 ™Ë◊ÕÀπ૬ߓπ -  ”π—°ß“π “∏“√≥ ÿ¢®ß— À«—¥ ∑«—Ë ª√–‡∑» -  ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“ - ‚√ß欓∫“≈¢Õß√∞— 385 ·Àßà æ√âÕ¡√“¬™Õ◊Ë ·π∫∑⓬ - °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å  à«π°≈“ß :  ”π—°¬“·≈–«—µ∂ÿ‡ æµ‘¥  «à π¿Ÿ¡‘¿“§ : »Ÿπ¬å«‘∑¬“»“ µ√°å “√·æ∑¬å 14 ·Ààß √“¬™◊ËÕºŸâ√à«¡¥”‡π‘π°“√  ”π°— ¬“·≈–«µ— ∂ÿ‡ æµ‘¥ π“ß “«®‘¥“¿“ °π° πÿ ∑√√—µπå π“ß»‘√‘«√√≥ ™—¬ ¡∫Ÿ√≥åæ—π∏å 𓬫’√– »≈‘ ª ÿ«√√≥™—¬ π“ß “«π‘¥“æ√√≥ ‡√Õ◊ ߃∑∏‘ππ∑å 𓬠¡™—¬ æ—π∏åÿÕπÿ°Ÿ≈ π“¬æŸ≈»—°¥‘Ï æ√À¡ «ÿ √√≥»√‘ ‘ π“ß ÿ≥¬’ å · ß‡¢’¬« π“ß “««‘¡≈«√√≥ «√‘π∑√åª√“‚¡∑¬å π“ßÕπߧåπ™ÿ ‡π¬‡¡◊Õßªí° π“ß “«‡¬“«≈—°…≥å «√√∏π–滑 ‘…Æå π“ߪء‘ “ ¡≥’ ∂‘µ¬å π“ß “«‡¡∑‘π’ À≈‘¡»‘√‘«ß…å π“ß “« ªÿ √“≥’ ‚√®π»—°¥Ï‘‚ ∏√ π“ß “«‡®√‘≠¥’ ªßî  ∑ÿ ∏‘«ß»å π“ß “« ®ÿ ‘𥓠‚√®π»—°¥Ï‘‚ ∏√ π“ß “«∑—»π’¬å ‚™§‡®√≠‘ √µ— πå π“ßÕ√æ≥‘ ∑π—π¢—µ‘ π“ߢ«≠— ƒ¥’ ≈È¡‘ ∑Õ߇®√≠‘ π“ß “««‘¬–¥“ Õ§— √«≤ÿ ‘ π“ß«‘¿“æ√√≥ ‰ ¬ ¡∫—µ‘ π“ß “«∫ß°™ æ—π∏∫å √Ÿ ≥“ππ∑å π“¬∑«’∑√—æ¬å ™—¬ ¡∫Ÿ√≥åæ—π∏å π“ß “«√…— Æ“¿√≥å §ß‡¡Õ◊ ß π“¬¡π—  Õ—µµ«‘™≠å π“ß “«®‘µ√“ ™—¬«—≤πå π“ß “«‚ ¡»‘√‘ ª√–∑ª’ –®µ‘ µ‘ π“ß “« ß«π »‘√‘Õ“√¬“ π“ß “« ÿ¿“≥’ ¥«ß∏’√ª√’™“ π“ß≥ª¿“  ‘√‘»ÿ¿°ƒµ°ÿ≈ π“¬ππ∑™‘ —¬ √®ÿ ‘√«≥™‘ ‡∑æ 1486 GREEN BOOK 4

√“¬™Ë◊ÕÀπ«à ¬ß“π·≈–ºŸâ√à«¡¥”‡ππ‘ °“√  ”π°— ¬“·≈–«µ— ∂‡ÿ  æµ‘¥ (µÕà ) π“ß “«Õ¡√  À‡¡∏“æ≤— πå π“ß “«∫ÿ≠±√‘°“ ∫ÿ≠≠“¿«‘ —≤πå π“ß ¿ÿ ∑— √“ ºàÕß»√’ π“ß “«‡¡∑π‘ ’ »√’ ÿπ“§√—« 𓬠√‘ ¿æ  —πµ‘∏‡π» π“ß “«√ßàÿ ∑‘æ¬å ‡®◊յΒ π“¬æ√™¬— µ√’‚≈‡°»«—≤π“ π“ß “««™‘ √≥¬’ å ∑Õß ¡‘ “ 𓬠¡»°— ¥Ï‘  πÿ ∑√æ“≥™‘ ¬å π“ß “« √≠“ ‡Œâß « — ¥‘Ï π“¬ —πµæ‘ ß»å «ß»å‡æÁ≠∑—°…å π“ß “« √‘ °‘ π— ¬“ ‡∑æ√—°…å 𓬠‘√‘™—¬ °√–∫’Ë»√’ π“ß “« ¿ÿ “«¥’  √ÿ “ߧ°å ≈ÿ π“ߪ«’≥“ ‡®√‘≠ ‘∑∏‘Ï π“ß “«Õ—ߧ≥“ Õ¡Ë‘ ‡Õ‘∫ π‘ π“ß “«æ—™√‘π∑√å ‡πË◊Õß “¬ π“ß “«Õ‘ßÕ√ ª√– “√™—¬¡πµ√’ π“ß “«Õπ≠— ≠“  ÿæπ— ∏«å ≥‘™ 𓬪√– ∑‘ ∏Ï‘ ‚Õ¿“… 𓬠¡¡“µ√å °≈¡°≈È‘ß π“¬ —𵑠πË‘¡πâÕ¬ π“ß«‘≤‘≥’ §ß ÿ¢ 𓬠∫◊ æß»å °”æ ÿ √‘ ‘ π“ß»»¥‘ “ Õ¬ àŸ ¢ÿ π“¬Õ¥‘»—°¥‘Ï À¡—πÀ≈‘π π“ß»»‘«‘¡≈ æ—≤‡ ¡“ 𓬠ÿ‡¡∏ ‡∑Ë’¬ß∏√√¡ π“ß “«®‘√“πÿ™ ·®à¡∑«’°ÿ≈ π“ß “«°π°æ√√≥ «√§™π‘ π“ß “«®’√π—π∑å ®ß«—≤π“π°ÿ ≈Ÿ π“ß “«∏“√∑‘æ¬å «™‘√»—°¥Ï‘«ß»å π“ß “«‰µ√æ√ «—≤ππ“∂ π“ß “«√®‡√¢ «‘‡™’¬√∑Õß π“ß “«≈—¥¥“ æŸ≈ «— ¥‘Ï π“ß “«»ÿ¿°“≠®πå »√’‡æ™Á √å π“ß “««≈—¬≈—°…≥å ‡¡∏“¿—∑√ π“ß “«°‘µµ å ¡ÿ π §ß‡ πÀà å π“ß “«»‘√‘æ√ ‡À≈“à ¡“𖇮√≠‘ π“ß “«™π‘¥“ °“πµåª√–™“ π“ß “« “√‘π’ ‡≈π–æπ— ∏ÿå π“ß “«√Õ∫∫È‘π ‚¿§“∏‘§¡ π“ß ¡ÿ π“ »‘√‘ ÿπ∑√ π“ß “« ÿ¡≥’ ‡≈‘»°π°°ÿ≈ π“ß “«∑—»æ√ ·§≈«â ÕÕâ ¡ 𓬻√—≥¬å ‡∫≠®¡ª√≠‘ ≠“°Ÿ≈ π“ß “««‘√¥“ ∏’√√—µπæ—π∏åÿ π“ß®‘∑“π—π∑å §√Õß ‘π π“ß “«»√—≠≠“ ‡ºà“æ◊™æ—π∏ÿå π“ßæ®π’¬å  “µ√¡≈Ÿ π“ß “«Õß— §≥“ °√‘™æ‘∑—°…å‡ß‘π π“ß “« ÿ¡‘µ√“ ‡∑’¬π´Õâ π π“ß “«°√«‘°“ ®“√ÿæ—π∏å π“ßæ√∑‘æ¬å ¥…‘ ∞ºÈß÷ π“ß “«°≠— ≠“¿§—  ÿ√æ—π∏åÿ °ÿ≈ °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 1497

√“¬™Ë◊ÕÀπ૬ߓπ·≈–º√Ÿâ «à ¡¥”‡π‘π°“√ »Ÿπ¬å«‘∑¬“»“ µ√å°“√·æ∑¬åπ§√√“™ ’¡“ π“ß ®√ÿ ¿’ √≥å ∫ÿ≥¬«ß»å«‘‚√®πå ºâŸÕ”𫬰“√ π“¬∫√√®ß °µ‘ ‘√µ— πåµ√–°“√ π“ß “«æ√ ∂µ‘ ¡ ’ ∂‘µ¬å π“߇撬߄® «ß»å ÿ«√√≥ π“ß°≈ÿ ∏¥‘ “ Õ”æπ— ∏∑å Õß »πŸ ¬«å ∑‘ ¬“»“ µ√°å “√·æ∑¬å ™≈∫√ÿ ’ 𓬠 ¡‡°¬’ √µ‘ ∫≠ÿ ≠–∫≠— ™“ ºŸâÕ”π«¬°“√ π“ß»√≥— ¬æ√ °‘®‰™¬“ π“ß “«®‘√—∞µ‘°√ «ß»Õå àÕ𵓠π“ß “«®√‘¬“ ·´à·æ π“ß “«‡æ¡Ë‘  ÿ¢  ÿ¢‡°…¡ »Ÿπ¬«å ‘∑¬“»“ µ√å°“√·æ∑¬å  ß¢≈“ 𓬠‡°√‘° √µ— Õ“¿“ ºŸâÕ”π«¬°“√ π“ß  “¬„® ª√‘¬–«“∑’ 𓬠«√’ –™—¬ æ‘æ—≤πå√—µπ‡ √’ π“ß “« «‘°≠— ≠“ ¡ß§≈∏“√≥å π“ß “« «—π∑𵑠¬å ‚≈À–π«°ÿ≈ π“ß “« ‡æ’¬ßæ∏Ÿ ®—π∑√ π“ߪ√–¿“ ‡æÁ™√¡“° π“ߪ√–¿“æ√√≥ ‡æ™√√—°…å 15408 GREEN BOOK 4