DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

More documents

Recommendations

Info

Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)2. ACE INHIBITORSThe following statement shall be included in the package inserts of productscontaining ACE inhibitors:WARNINGINCREASED RISK OF BIRTH DEFECTS, FOETAL AND NEONATALMORBIDITY AND DEATH WHEN USED THROUGHOUT PREGNANCYUSE IN PREGNANCYINCREASED RISK OF BIRTH DEFECTS, FOETAL AND NEONATALMORBIDITY AND DEATH WHEN USED THROUGHOUT PREGNANCYReference: Circular Bil (65) dlm BPFK/02/5/1.3: Produk yang Mengandungi 'ACE Inhibitors'3. ACETYLSALICYLIC ACID (ASPIRIN)For products containing Acetylsalicylic acid, the following warning shall beincluded on the labels in two languages (Bahasa Malaysia and English):AMARANTIDAK BOLEH DIBERI KEPADA KANAK-KANAK BERUMUR KURANGDARIPADA 16 TAHUN.WARNINGNOT TO BE GIVEN TO CHILDREN UNDER 16 YEARS OF AGE.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 352
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)4. ACTIVATED CHARCOAL/ ATTAPULGITE4.1 The following boxed warning shall be included on the labels of productscontaining Activated charcoal/ attapulgite:NOT RECOMMENDED FOR TREATMENT OF DIARRHOEAIN CHILDREN UNDER 6 YEARS OF AGE4.2 The following statements shall be included in the package inserts ofproducts containing Activated charcoal/ attapulgite:Not recommended for treatment of diarhoeain children under 6 years of ageWARNINGActivated charcoal/ attapulgite may interfere with the absorption of otherdrugs, including antibiotics, when administered concurrently.PRECAUTIONAppropriate fluid and electrolyte therapy should be given to protect againstdehydration. Oral rehydration therapy which is the use of appropriate fluidsincluding oral rehydration salts remains the most effective treatment fordehydration due to diarrhoea. The intake of as much of these fluids aspossible is therefore imperative.5. ALBENDAZOLE & BENZIMIDAZOLE ANTIHELMINTICSThe following statement shall be included on the labels and in the packageinserts of products containing Albendazole or Benzimidazole antihelmintics:SHOULD NOT BE ADMINISTERED DURING CONFIRMED OR SUSPECTEDPREGNANCY6. ALFALFA (MEDICO SATIVA)The following boxed warning shall be included on the labels of productscontaining Alfalfa (Medico sativa):This product contains Alfalfa (Medico sativa).Individual with a predisposition to systemic lupus erythematosusshould consult their physician before consuming this product.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 353
Page 2 and 3:
Drug Registration Guidance Document
Page 5 and 6:
Page 7 and 8:
Page 9 and 10:
Page 11 and 12:
Page 13 and 14:
Page 15 and 16:
Page 17 and 18:
Page 19 and 20:
Page 21 and 22:
Page 23 and 24:
Page 25 and 26:
Page 27 and 28:
Page 29 and 30:
Page 31:
Page 34 and 35:
Page 36 and 37:
Page 38 and 39:
Page 40 and 41:
Page 42 and 43:
Page 44 and 45:
Page 46 and 47:
Page 48 and 49:
Page 50 and 51:
Page 52 and 53:
Page 54 and 55:
Page 56 and 57:
Page 58 and 59:
Page 60 and 61:
Page 62 and 63:
Page 64 and 65:
Page 66 and 67:
Page 68 and 69:
Page 70 and 71:
Page 72 and 73:
Page 74 and 75:
Page 76 and 77:
Page 78 and 79:
Page 80 and 81:
Page 82 and 83:
Page 84 and 85:
Page 86 and 87:
Page 88 and 89:
Page 90 and 91:
Page 92 and 93:
Page 94 and 95:
Page 96 and 97:
Page 98 and 99:
Page 100 and 101:
Page 102 and 103:
Page 104 and 105:
Page 106 and 107:
Page 108 and 109:
Page 110 and 111:
Page 112 and 113:
Page 114 and 115:
Page 116 and 117:
Page 118 and 119:
Page 120 and 121:
Page 122 and 123:
Page 124 and 125:
Page 126 and 127:
Page 128 and 129:
Page 130 and 131:
Page 132 and 133:
Page 134 and 135:
Page 136 and 137:
Page 138 and 139:
Page 140 and 141:
Page 142 and 143:
Page 144 and 145:
Page 146 and 147:
Page 148 and 149:
Page 150 and 151:
Page 152 and 153:
Page 154 and 155:
Page 156 and 157:
Page 158 and 159:
Page 160 and 161:
Page 162 and 163:
Page 164 and 165:
Page 166 and 167:
Page 168 and 169:
Page 170 and 171:
Page 172 and 173:
Page 174 and 175:
Page 176 and 177:
Page 178 and 179:
Page 180 and 181:
Page 182 and 183:
Page 184 and 185:
Page 186 and 187:
Page 188 and 189:
Page 190 and 191:
Page 192 and 193:
Page 194 and 195:
Page 196 and 197:
Appearance/organoleptic(odor, color
Page 198 and 199:
Page 200 and 201:
Page 202 and 203:
Page 204 and 205:
Page 206 and 207:
Page 208 and 209:
Page 210 and 211:
Page 212 and 213:
Page 214 and 215:
ATTACHMENT 1Drug Registration Guida
Page 216 and 217:
Page 218 and 219:
Page 220 and 221:
Page 222 and 223:
PART IV: CLINICAL DOCUMENTSDrug Reg
Page 224 and 225:
ATTACHMENT 2Drug Registration Guida
Page 226 and 227:
Page 228 and 229:
Page 230 and 231:
APPENDIX 5:Drug Registration Guidan
Page 232 and 233:
1. GENERAL INFORMATIONSDrug Registr
Page 234 and 235:
Page 236 and 237:
Page 238 and 239:
Page 240 and 241:
Page 242 and 243:
Page 244 and 245:
Page 246 and 247:
Page 248 and 249:
Page 250 and 251:
Page 252 and 253:
Page 254 and 255:
Page 256 and 257:
Page 258 and 259:
Page 260 and 261:
Page 262 and 263:
Page 264 and 265:
Page 266 and 267:
Page 268 and 269:
Route of AdministrationTAMC(CFU/g o
Page 270 and 271:
Page 272 and 273:
Page 274 and 275:
Page 276 and 277:
d) Example of label approved by the
Page 278 and 279:
Page 280 and 281:
Page 282 and 283:
Page 284 and 285:
Page 286 and 287:
Page 288 and 289:
Page 290 and 291:
Page 292 and 293:
Page 294 and 295:
Page 296 and 297:
Page 298 and 299:
Page 300 and 301:
Page 302 and 303: Drug Registration Guidance Document
Page 402 and 403:
Page 404 and 405:
Page 406 and 407:
Page 408 and 409:
Page 410 and 411:
Page 412 and 413:
Page 414 and 415:
Page 416 and 417:
Page 418 and 419:
Page 420 and 421:
Page 422 and 423:
Page 424 and 425:
Page 426 and 427:
Page 428 and 429:
Page 430 and 431:
Page 432 and 433:
Page 434 and 435:
Page 436 and 437:
Page 438 and 439:
Page 440 and 441:
Page 442 and 443:
Page 444 and 445:
Page 446 and 447:
Page 448 and 449:
Page 450 and 451:
Page 452 and 453:
Page 454 and 455:
Page 456 and 457:
Page 458 and 459:
Page 460 and 461:
Page 462 and 463:
Page 464 and 465:
Page 466 and 467:
Page 468 and 469:
Page 470 and 471:
Page 472 and 473:
Page 474 and 475:
Page 476 and 477:
Page 478 and 479:
Page 480 and 481:
Page 482 and 483:
Page 484 and 485:
Page 486:
show all

DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?