Dokumen registrasi NOTIFIKASI yang diserahkan (Revisi 12 April 2018) Dokumen registrasi notifikasi yang diserahkan sebagai berikut : 1 Set-1 : Dokumen Arsip a. Dokumen administratif - Checklist registrasi variasi (bagian administrasi dan bagian notifikasi yang diajukan) - Surat Pengantar - Tabel sandingan perubahan (lihat keterangan) - Surat pernyataan pendaftar - Surat pernyataan registrasi notifikasi - Formulir registrasi - Sertifikat CPOB, ijin industri, dokumen perjanjian (sesuai dengan status produksi: dalam negeri, kontrak, lisensi, ekspor, impor) - Sertifikat GMP zat aktif yang masih berlaku - Copy NIE dan/atau surat persetujuan perubahan terkait dengan yang diajukan, yang diterbitkan oleh Badan POM beserta lampirannya. b. Dokumen Change control yang dijadikan acuan melakukan perubahan. c. Dokumen penandaan/mutu sesuai jenis perubahan yang diajukan (mengikuti checklist registrasi variasi (bagian notifikasi)) 2 Set -2 : Dokumen untuk Ditwas Produksi Obat, Narkotika, Psikotropika dan Prekusor (jika terkait dengan perubahan mutu) - Surat Pengantar - Tabel sandingan perubahan (lihat keterangan) - Dokumen mutu sesuai jenis perubahan yang diajukan - 3 4 Set -3 : Dokumen untuk Ditwas Distribusi dan Pelayan Obat, Narkotika, Psikotropika dan Prekusor (jika terkait perubahan informasi produk dan penandaan) - Surat Pengantar - Tabel sandingan perubahan (lihat keterangan) - Dokumen penandaan sesuai jenis perubahan yang diajukan Set -4 : Dokumen untuk Ditwas Keamanan, Mutu dan Ekspor Impor Obat, Narkotika, Psikotropika, Prekusor dan Zat Adiktif jika terkait perubahan informasi produk dan penandaan - Surat Pengantar - Tabel sandingan perubahan (lihat keterangan) - Dokumen penandaan sesuai jenis perubahan yang diajukan 5 Set-5 :Dokumen Industri - Surat Pengantar - Tabel sandingan perubahan (lihat keterangan) 5 Set-6 :Loket - Formulir Registrasi (semua perubahan harus dicantumkan pada bagian "kategori registrasi") Keterangan (WAJIB DIBACA): - Tabel sandingan dicetak pada kertas kop pendaftar dan ditandatangani oleh penanggung jawab pemastian mutu - Tabel sandingan perubahan dibuat terperinci harus disertai dengan justifikasi, informasi waktu mulai diterapkannya perubahan, serta informasi nomor dan judul dokumen Change control yang dijadikan acuan melakukan perubahan (jika ada perubahan desain kemasan, desain kemasan lama dan yang diajukan juga harus disandingkan dalam satu halaman) - Perubahan desain kemasan harus menyerahkan mock up kemasan yang diajukan (sebagai syarat dokumen penandaan). - Tiap Set sudah harus diberi tanda peruntukannya (untuk: Arsip/Wasprod/WasDist/WasKMEIO/Industri/Loket) dan di set terpisah oleh Pendaftar.
JADWAL PELAYANAN REGISTRASI VARIASI & RENEWAL OBAT GENERIK Kepada Industri Farmasi : "Agar produk yang di-input ke dalam website antrian email adalah produk yang sudah siap kelengkapannya sesuai dengan checklist registrasi yang diajukan, untuk menghindari terjadinya penggantian produk saat waktu pelayanan dan ketidaksiapan dokumen yang sudah dijadwalkan. Terima kasih." REGISTRASI VARIASI OG (BERKAS BARU) 1 Senin, 16 April 2018 PT. PHAROS INDONESIA POLYSILANE 180 2 Senin, 16 April 2018 PT. PHAROS INDONESIA Clinovir 400 3 Senin, 16 April 2018 PT. PYRIDAM TBK Vibramox Forte 4 Senin, 16 April 2018 PT. PYRIDAM TBK PYXIME 5 Senin, 16 April 2018 PT Ethica ETHINEX 6 Senin, 16 April 2018 PT Ethica CETADOP 7 Senin, 16 April 2018 PT.NELLCO INDOPHARMA OBH NELLCO 8 Senin, 16 April 2018 PT.NELLCO INDOPHARMA OBH NELLCO PLUS 9 Senin, 16 April 2018 PT. Finusolprima Farma Internasional Metrofusin 10 Senin, 16 April 2018 PT. Finusolprima Farma Internasional Metrofusin 1 Selasa, 17 April 2018 PT. PHAROS INDONESIA LIMOXIN 2 Selasa, 17 April 2018 PT RAMA EMERALD MULTI S CETIRIZINE HYDROCHLORIDE 3 Selasa, 17 April 2018 PT RAMA EMERALD MULTI S CETIZINE 4 Selasa, 17 April 2018 PT. Catur Dakwah Crane Farmasi Sinoplant 5 Selasa, 17 April 2018 PT. Catur Dakwah Crane Farmasi Susuk KB II Tiga Tahunan 6 Selasa, 17 April 2018 PT. Dexa Medica GLIQUIDONE 7 Selasa, 17 April 2018 PT PHAROS INDONESIA ACLONAC 50 8 Selasa, 17 April 2018 IPHA Levoipha 9 Selasa, 17 April 2018 PT. IPHA Ciproipha 10 Selasa, 17 April 2018 PT. Indofarma omeprazole 20 mg
RESUBMIT REGISTRASI VARIASI OG 1 Senin, 16 April 2018 PT Lloyd Pharma Indonesia Bimalcus 2 Senin, 16 April 2018 3 Senin, 16 April 2018 4 Senin, 16 April 2018 5 Senin, 16 April 2018 6 Senin, 16 April 2018 7 Senin, 16 April 2018 8 Senin, 16 April 2018 9 Senin, 16 April 2018 10 Senin, 16 April 2018 1 Selasa, 17 April 2018 2 Selasa, 17 April 2018 3 Selasa, 17 April 2018 4 Selasa, 17 April 2018 5 Selasa, 17 April 2018 6 Selasa, 17 April 2018 7 Selasa, 17 April 2018 8 Selasa, 17 April 2018 9 Selasa, 17 April 2018 10 Selasa, 17 April 2018
RENEWAL OG 1 Senin, 16 April 2018 PT. Rama Emerald Multi Sukses Furotason 2 Senin, 16 April 2018 PT Actavis Indonesia ALPENTIN 3 Senin, 16 April 2018 PT. Combiphar BRONCHOPRONT 4 Senin, 16 April 2018 PT. NICHOLAS NICHOMYCIN INDONESIA 5 Senin, 16 April 2018 PT. Dipa Pharmalab Intersains Valesco 40 mg 6 Senin, 16 April 2018 PT. INFION DANSEFION 7 Senin, 16 April 2018 PT Bromo Pharmaceutical Industries obat sakit kepala cap Pedang 8 Senin, 16 April 2018 PT. Sunthi Sepuri Calmlet 0.5 mg 9 Senin, 16 April 2018 PT. ETHICA NEUROPHIL 10 Senin, 16 April 2018 PT. Phapros, Tbk Phadilon 500 SI 1 Selasa, 17 April 2018 PT.SOHO SOHOBION 2 Selasa, 17 April 2018 PT.SOHO ARBITEN 150 3 Selasa, 17 April 2018 PT.SOHO ARBITEN 300 4 Selasa, 17 April 2018 PT LAPI Lapimox 500 5 Selasa, 17 April 2018 PT. Kalbe Farma VOMCERAN 2 ML 6 Selasa, 17 April 2018 PT. Kalbe Farma VOMCERAN 4 ML 7 Selasa, 17 April 2018 PT.Indofarma Diethylcarbamazine 8 Selasa, 17 April 2018 PT.Indofarma oralit 200 9 Selasa, 17 April 2018 PT SANBE CEFORIM (resubmit) 10 Selasa, 17 April 2018 PT SANBE AMOXICILLIN Siker 1 Rabu, 18 April 2018 PT Dexa Medica BISCOR 2 Rabu, 18 April 2018 PT. DEXA MEDICA Magalat 3 Rabu, 18 April 2018 PT SANBE CLANEKSI Siker 4 Rabu, 18 April 2018 PT SANBE CLANEKSI 500 5 Rabu, 18 April 2018 PT. MERSI TM CARBAMAZEPINE 6 Rabu, 18 April 2018 PT. Mega Esa Farma Mesaflukin 7 Rabu, 18 April 2018 PT LAPI ANALTRAM 8 Rabu, 18 April 2018 PT. First Medipharma Cimetidine 9 Rabu, 18 April 2018 PT CENDO Vasacon A (15 ml) 10 Rabu, 18 April 2018 PT CENDO Vasacon A (5 ml) 1 Kamis, 19 April 2018 PT.NELLCO INDOPHARMA nellco special OBH untuk anak-anak ( rasa strawbery ) 55 ml 2 Kamis, 19 April 2018 PT.NELLCO INDOPHARMA nellco special OBH untuk anak-anak ( rasa strawberry) 100ml 3 Kamis, 19 April 2018 PT.NELLCO INDOPHARMA nellco special OBH untuk anak-anak ( rasa jeruk ) 100 ml 4 Kamis, 19 April 2018 PT.NELLCO INDOPHARMA nellco special obh untuk anak-anak ( rasa Jeruk) 55 ml 5 Kamis, 19 April 2018 PT Medifarma GASTRAN 6 Kamis, 19 April 2018 PT. MOLEX AYUS LEXAMET 7 Kamis, 19 April 2018 PT. HARBAT Thiamphenicol 8 Kamis, 19 April 2018 PT. Dankos Farma, Jakarta HEXILON 4 9 Kamis, 19 April 2018 PT.Dipa Pharmalab Intersains AVESCO 10 10 Kamis, 19 April 2018 PT.Dipa Pharmalab Intersains AVESCO 20
CADANGAN REGISTRASI VARIASI OC No. PENDAFTAR NAMA OBAT 1 PT Ethica ZANTADIN 2 PT.NELLCO INDOPHARMA Nellco Special OBH ( Rasa Madu ) 3 PT.NELLCO INDOPHARMA Nellco Special OBH ( Rasa Jahe ) 4 PT.NELLCO INDOPHARMA DEXANEL 5 PT. IFARS ZIDALEV 6 PT. IFARS LEVOFLOXACIN 7 PT. IFARS FASIDOL FORTE 8 PT Darya-Varia Laboratoria TbkOmeprazole Sodium 9 PT. Bufa Aneka Hydrocortisone Acetate 10 PT. Imfarmind Paracetamol 11 PT Bromo Pharmaceutical Industries obat anak sumang cap pedang rasa jeruk 12 PT Bromo Pharmaceutical obat anak sumang cap pedang Industries 13 PT. NOVAPHARIN Domperidone Maleate 14 PT. NOVAPHARIN Amoxicillin 15 PT Harsen Dexaharsen 0,5 16 PT Harsen Dexaharsen 0,75 17 PT. Mahakam Beta Farma Betarhin 18 PT. Bernofarm METRONIDAZOLE 19 PT. GUARDIAN THECORT PHARMATAMA 20 PT. IFARS FARIZOL 21 PT. IFARS METRONIDAZOLE 22 pt otto pharmaceutical OPIVASK 5 industries 23 pt otto pharmaceutical OPIVASK 10 industries 24 pt otto pharmaceutical amlodipine 5 mg industries 25 pt otto pharmaceutical industries amlodipine 10 mg 26 PT. NATURA LABORATORIA AZITUM 27 PT. NATURA LABORATORIA AZITHROMYCIN DIHYDRATE 28 PT. Dion Farma Abadi, Klaten Alendion 29 PT. Dion Farma Abadi, Klaten Benzodion-Cl 30 PT. Dion Farma Abadi, Klaten Clindion 31 PT. Dion Farma Abadi, Klaten Clindion 32 PT. Holi Pharma Dexamethasone 33 PT. Dion Farma Abadi, Klaten Retion 0,025% 34 PT. Dion Farma Abadi, Klaten Retion 0,05% 35 PT. Dion Farma Abadi, Klaten Retion 0,1% 36 PT. Dion Farma Abadi, Klaten Tricodion 37 PT. Dion Farma Abadi, Klaten Calmdion 38 PT. Mahakam Beta Farma Betarhin 39 PT. Pharos Indonesia Ferotam Dry Injeksi 40 PT IFARS Pharmaceutical Cydifar 41 PT LAPI L-zinc sirup 42 PT LAPI A-B VASK 43 PT Bromo Pharmaceutical Industries obat anak sumang cap pedang rasa jeruk 44 PT Bromo Pharmaceutical obat anak sumang cap pedang Industries 45 PT Bromo Pharmaceutical Industries obat anak sumang cap pedang rasa jeruk 46 PT. Promedrahardjo FI Magten 47 PT. NOVELL OFLOXACIN 48 PT PERTIWI AGUNG Lanavir 49 PT. Futamed Cetirizine HCl 50 PT. Futamed Omeprazole
51 PT Dexa Medica VOMETA 52 PT Dexa Medica DOMPERIDONE 53 PT Ferron Par VIDON 54 PT. Bernofarm ASAM TRANEKSAMAT 55 PT. Bernofarm TRANXA 56 PT. Bernofarm ASAM TRANEKSAMAT 500 mg/5ml 57 PT DARYA-VARIA CEFTRIAXONE SODIUM LABORATORIA TBK 58 PT DARYA-VARIA CEFEPIME HCL LABORATORIA TBK 59 PT BERNOFARM CLINDAMUCIN HCL 60 PT. MOLEX AYUS MOMESAN 61 PT. MOLEX AYUS Methylprednisolone 62 PT Dexa Medica DOMPERIDONE 63 PT Ferron Par VIDON 64 PT Dexa Medica VOMETA 65 PT. Pharma Health Care INSTO DRY EYES 66 PT. MOLEX AYUS PRITAMOX 67 PT. NOVAPHARIN Novachlor 68 PT Aventis Pharma Recansa 69 PT. Mulia Farma Suci GENCOPAN 70 PT. Mulia Farma Suci GENCOPAN PLUS 71 PT. Mahakam Beta Farma Larce 1000 72 PT. Mahakam Beta Farma Larce 500 73 PT. Mahakam Beta Farma Larce 200 74 PT. CORONET CROWN COROBION 75 PT. PRATAPA NIRMALA RENADINAC 50 76 PT. Imfarmind Mefenamic Acid 77 PT. Hexpharm Jaya Ranitidin tablet 78 Pt. Hexpharm jaya Titan 79 PT. PRATAPA NIRMALA Renadinac 25 80 PT. Combiphar OBH COMBI Batuk Plus Flu Rasa Madu 81 PT. PHAROS INDONESIA VALDRES 82 PT. Mulia Farma Suci ORAPROFEN 83 PT. Mulia Farma Suci oraprofen forte 84 pt. kimia farma miconazole 85 PT Hexpharm Jaya RANITIDINE 150 86 PT Hexpharm Jaya TITAN 150 87 PT. Hexpharm Jaya Methylprednisolone 16 88 PT. Hexpharm Jaya Methylprednisolone 16 89 PT. Hexpharm Jaya Methylprednisolone 4 90 PT. Hexpharm Jaya Metisol 4 91 PT. PHAROS INDONESIA Clinidac 92 PT. HARBAT Thiamphenicol 93 PT. Pratapa Nirmala, PLANIBU Tangerang 94 PT. GRATIA HUSADA Hufagripp TMP 95 PT.NATURA LABORATORIA AZITUM 96 PT. GRATIA HUSADA Hufafural 97 PT. NATURA LABORATORIA AZITHROMYCIN DIHYDRATE 98 PT. GRATIA HUSADA Hufallerzine Expectorant 99 PT. GRATIA HUSADA HUFRALGIN 100 PT. GRATIA HUSADA Hufasulvon Kids
101 PT. GRATIA HUSADA PASABA COUGH AND FLU 102 PT. GRATIA HUSADA HUFAGESIC 103 PT. GRATIA HUSADA Anastan Forte 104 PT. GRATIA HUSADA PASABA EXPECTORANT 105 PT. Hexpharm Jaya PIRACETAM 800 106 PT Pharma Health Care Neostigmine-hameln 107 PT. INTERBAT INTERZINC 108 PT. INTERBAT INADRYL 109 PT. INTERBAT INDEXON 110 PT. Dipa Pharmalab Intersains GABESCO 111 PT Dexa Medica Recofol N 112 PT. PHARMA CEFADROXIL 113 PT. PHARMA CEFADROXIL 114 PT MEPROFARM NIKOLAM 115 PT PERTIWI AGUNG Lanavir 116 pt. kimia farma miconazole 117 PT.Rama Emerald Multi Remco Cough Sukses 118 PT. PHAROS INDONESIA Clinidac 119 PT. HARBAT Thiamphenicol 120 PT. Pratapa Nirmala, PLANIBU Tangerang 121 PT. GRATIA HUSADA Hufagripp TMP 122 PT.NATURA LABORATORIA AZITUM 123 PT. GRATIA HUSADA Hufafural 124 PT. NATURA LABORATORIA AZITHROMYCIN DIHYDRATE 125 PT. GRATIA HUSADA Hufallerzine Expectorant 126 PT. GRATIA HUSADA HUFRALGIN 127 PT. GRATIA HUSADA Hufasulvon Kids 128 PT. GRATIA HUSADA PASABA COUGH AND FLU 129 PT. GRATIA HUSADA HUFAGESIC 130 PT. GRATIA HUSADA Anastan Forte 131 PT. GRATIA HUSADA PASABA EXPECTORANT 132 PT. Hexpharm Jaya PIRACETAM 800 133 PT. IFARS AMOXICILLIN 134 PT. IFARS FASIPRIM FORTE 135 PT Pharma Health Care Neostigmine-hameln 136 PT. INTERBAT INTERZINC 137 PT. INTERBAT INADRYL 138 PT. INTERBAT INDEXON 139 PT. Dipa Pharmalab Intersains GABESCO 140 PT Dexa Medica Recofol N 141 PT. PHARMA CEFADROXIL 142 PT. PHARMA CEFADROXIL 143 PT. Triman TRIMOL 144 PT MEPROFARM NIKOLAM 145 PT PERTIWI AGUNG Lanavir 146 PT KONIMEX KONVERMEX 250 147 PT KONIMEX KONVERMEX 125 148 PT. SAMCO SAMTETRA 149 PT. HARBAT AMLODIPIN BESYLATE - 5 150 PT. HARBAT AMLODIPIN BESYLATE - 10
151 PT. Novell Pharmaceutical DEXPAIN INJEKSI 152 PT. Novell Pharmaceutical DEXPAIN TSS 153 PT. NELLCO INDOPHARMA Nellco Special OBH Anak Rasa Coklat 154 PT. NELLCO INDOPHARMA Nellco Special OBH ( Rasa Madu ) 155 PT. IFARS FLOXIFAR 156 PT. IFARS CIPROFLOXACIN 157 PT Fonko International FONKOGEM, VIAL 200 158 PT Fonko International FONKOGEM, VIAL @1000 159 PT. Pratapa Nirmala Sotatic 160 Dexa Medica OMEPRAZOLE SODIUM 161 PT. TRIMAN SUPERHOID 162 PT. HARBAT AMLODIPIN BESYLATE - 5 163 PT. HARBAT AMLODIPIN BESYLATE - 10 164 PT KONIMEX KONVERMEX 250 165 PT KONIMEX KONVERMEX 125 166 PT Lloyd Pharma Indonesia NEUCOMPLI 167 PT PRATAPA NIRMALA DOL 50 168 PT Darya Varia Laboratoria, Vicks Formula 44 Tbk 169 PT. PRATAPA NIRMALA Farmadol 100 + Generik 170 PT. Pratapa Nirmala Sotatic 171 PT. Pratapa Nirmala Inpepsa 172 PT Dexa Medica Hyperil 173 PT Dexa Medica Hyperil 174 PT Bayer Indonesia Upixon 175 PT SANBE PROANES 176 PT Yarindo Farmatama Aciclovir 200 177 PT. MEPROFARM ANCEFA DS 178 PT IKAPHARMINDO AROMARA 179 PT. MOLEX AYUS LEXAVON 180 PT Dexa Medica Ramipril 181 PT Ferron Par Tenapril 2.5 182 PT Ferron Par Tenapril 5 183 PT Ferron Par Atorvastatin Calcium 10 184 PT Ferron Par Atorvastatin Calcium 20 185 PT Gracia Pharmindo GRAFED 186 PT. MOLEX AYUS ALPHAMOL 187 PT. MOLEX AYUS LEXAVON 188 PT Ikapharmindo Putramas LACTULOSE 189 PT PERTIWI AGUNG CAPTOPRIL 190 PT Darya-Varia Laboratoria SUPERTETRA Tbk 191 PT SANDOZ INDONESIA ANUVA 192 PT Darya-Varia Laboratoria Cefepime HCI 193 PT Darya-Varia Laboratoria Cefuroxime Sodium 194 PT. PHARMA CEFADROXIL 125 DS 195 PT. PHARMA CEFADROXIL 250 DS 196 PT Harsen Dexaharsen 0,5 197 PT HARSEN Dexaharsen 0,75 198 PT. Guardian Pharmatama Fungasol 199 PT GRACIA PHARMINDO GRAFED 200 PT. Kalbe Farma DOMINIC
201 PT. PRATAPA NIRMALA ATOFAR 10 & Atorvastatin 10 202 PT. PRATAPA NIRMALA ATOFAR 20 &Atorvastatin 20 203 PT. PRATAPA NIRMALA ATOFAR 40 & Atorvastatin 40 204 PT.BERNOFARM MEFENAMIC ACID 205 PT.BERNOFARM BENOSTAN 206 PT. PHAROS INDONESIA STELAZINE 207 PT. SAMCO SAMTETRA 208 PT. SAMCO samquinor 209 PT Harsen PILKAB 210 PT. INTERBAT INDEXON 211 PT. Futamed Fumethyl 4 212 PT. Triyasa Nagamas Farma Obat Suntik KB I 213 PT. GUARDIAN URSOLIC PHARMATAMA 214 PT KONIMEX KONIDIN 215 PT Kalbe Farma Kalpanax K 216 PT RAMA EMERALD MULTI RAMADRYL EXPECTORANT S 217 PT. Sterling Products Triaminic Pilek Indonesia 218 PT. Sterling Products Triaminic Batuk & pilek Indonesia 219 PT. Sterling Products Triaminic Ekspektoran & Pilek Indonesia 220 PT PRATAPA NIRMALA Metacosfar 50 221 PT PRATAPA NIRMALA Metacosfar 100 222 PT. Sampharindo Perdana Broadamox 223 PT. Sampharindo Perdana Broadamox DS 250 224 PT. Sampharindo Perdana Amoxicillin DS 125 225 PT. Mulia Farma Suci GLENISTAN 226 PT. Mulia Farma Suci Asam Mefenamat 227 PT SANDOZ INDONESIA ANUVA 228 PT. Tempo Scan Pacific DBL Gemcitabine 229 PT MEDIKA Durocort 230 Kalbe Farma KALPANAX 10 ml 231 PT KONIMEX SILADEX COUGH & COLD 30 ml 232 PT KONIMEX SILADEX COUGH & COLD 60 ml 233 PT Pyridam Farma Tbk. LECRAV 234 PT. Etercon Pharma NASALYN 235 PT. Tunggal Idaman Abdi Platogrix 236 PT IFARS Pharmaceutical TERNIX 237 PT. Rama Emerald Multi Riamycin Sukses 238 PT WIDATRA BHAKTI SODIUM CHLORIDE 0,9% 500 ml 239 PT WIDATRA BHAKTI WIDA NS 240 PT. TRIMAN TRIMALGIN 241 PT OTSUKA INDONESIA Otsu Manitol 242 PT OTSUKA INDONESIA Otsu RS 243 PT MEDIKA Durocort 244 PT. Sampharindo Perdana Broadamox 125 245 PT. Sampharindo Perdana Broadamox 250 246 PT. Sampharindo Perdana Amoxicillin DS 125 (variasi) 247 PT IFARS MEGATIC 50 248 PT OTSUKA INDONESIA OTSU D10 249 PT OTSUKA INDONESIA OTSU D5 100 ml 250 PT MULIA SUCI GENCEF 125
251 PT MULIA SUCI CEFADROXIL MONOHYDRATE 252 PT MULIA SUCI METHYLPREDNISOLONE 8 MG 253 PT MULIA SUCI METILGEN 8 254 PT OTSUKA INDONESIA OTSU - NS 255 PT OTSUKA INDONESIA STERILE WATER FOR IRRIGATION USP 256 PT OTSUKA INDONESIA OTSU-NS 257 PT OTSUKA INDONESIA OTSU-D10 258 PT OTSUKA INDONESIA KA-EN 4B 259 PT OTSUKA INDONESIA OTSU-MANITOL 20 260 PT. RAMA EMERALD MULTI RAMAGESIC 261 PT. RAMA EMERALD MULTI IBUPROFEN SUPENSI 262 PT. RAMA EMERALD MULTI RAVASK 5 263 PT. RAMA EMERALD MULTI TERA-F 264 PT. RAMA EMERALD MULTI RAMOLIT 265 PT. RAMA EMERALD MULTI IBUPROFEN TABLET 266 PT. RAMA EMERALD MULTI CALORTUSIN 267 PT COMBIPHAR ATRACURIUM - HAMELN (2,5 ML) 268 PT COMBIPHAR ATRACURIUM - HAMELN (5 ML) 269 PT KALBE LATIPRESS 270 PT PROMEDRAHARDJO PIROXICAM 271 PT. RAMA EMERALD MULTI FENPRO 272 PT. RAMA EMERALD MULTI AMLODIPINE BESILATE 273 PT. RAMA EMERALD MULTI PARACETAMOL 274 PT MEDIKA DUROCORT 275 PT.RAMA EMERALD MULTI ORALIT S 276 PT HEXPHARM JAYA ANFUHEX 277 PT HEXPHARM JAYA KETOCONAZOLE 278 PT HEXPHARM JAYA RANITIDINE HACL 279 PT HEXPHARM JAYA LIBROCEF 500 280 PT. MOLEX AYUS MOLASIC 281 PT GRACIA PHARMINDO ZEMINDO 282 PT. SANBE INFUSAN - NS (resubmit) 283 PT DIPA PHARMALAB DIBUCARDIN INTERSAINS 284 PT BERNOFARM MEROPENEM 285 PT PROMEDRAHARDJO MAGTEN 286 PT STERLING PRODUCTS TRIAMINIC BATUK & PILEK INDONESIA 287 PT. NOVAPHARIN VADROL 288 PT.BERNOFARM RANITIDINE HCL 289 PT.BERNOFARM ANITID 290 PT HARSEN DECAFIL 291 PT SUNTHI SEPURI CYCLO PROTHYRA 292 PT HOLI PHARMA PREDNISON 293 PT TEMPO SCAN PACIFIC TBK AMLODIPINE BESILATE
CADANGAN REGISTRASI ULANG No. Pendaftar Produk Tanggal Berakhir NIE 1 PT SANBE CLINDAMYCIN (Resubmit) 31 Desember 2017 2 PT. SANBE TENSICAP 25 (Resubmit) 31-12-2017 3 PT. SANBE TENSICAP 12,5 31-12-2017 4 PT. SANBE DAMABEN (Resubmit) Sirup 31-12-2017 5 PT. SANBE DAMABEN (Resubmit) Drop 31-12-2017 6 PT SANBE SANMOL 120 Child Chewable 24-08-2017 (Resubmit) 7 PT Sanbe Farma EPEXOL (resubmit) 22-05-2017 8 PT SANBE ANALSIK (Resubmit) 31-12-2017 9 PT Sanbe Farma MEROSAN 1 (Resubmit) 29-08-2017 10 PT. SANBE Thiamphenicol (Re submit) 31 Desember 2017 11 PT. SANBE CIPROFLOXACIN 500 31 Desember 2017 12 PT. Kalbe Farma, Tbk Primazole 14 April 2019 13 PT. Kalbe Farma, Tbk Divoltar 19 Agustus 2018 14 PT DEXA MEDICA ACICLOVIR 200 24-12-2018 15 PT DEXA MEDICA ZOREL 400 12-11-2018 16 PT. Indofarma Gemfibrozil 600 31-10-2018 17 PT. Dankos Farma, Jakarta HEXILON 8 31-10-2018 18 PT. PERTIWI AGUNG LANADEXON 23 Oktober 2018 19 PT. Dankos Farma, Jakarta HEXILON 16 31-10-2018 20 PT. PHAROS INDONESIA LAMIROS 50 10 MEI 2018 21 PT. Medikon Prima MEDIMOX-125 22 APRIL 2018 22 PT RAMA EMERALD MULTI Metronidazole 28-10-2018 S 23 PT. Kalbe Farma LANCID 06 Sep 2018 24 PT. Lapi Laflanac 22/08/2018 25 PT Yarindo Farmatama Aciclovir 200 23-02-2018 26 PT Harsen Tensidox 2 23 Juli 2018 27 PT Actavis Indonesia Ariski 10 mg 1-04-2019 28 PT Actavis Indonesia Ariski 15 mg 1-04-2019 29 PT HARSEN METROLET 500 23 DESEMBER 2018 30 PT. HARBAT Thiamphenicol 04-03-2018 31 PT. SOLAS LANGGENG SOLAFEXONE 14-03-2018 SEJAHTERA 32 PT Armoxindo Farma PONCOSOLVON (Sirup) 26-04-2018 33 PT Armoxindo Farma PONCOSOLVON (Tablet) 24-04-2018 34 PT. NATURA LABORATORIA RANITIDINE HCL 22 April 2018 35 PT. INFION RANIFIN 15 Juli 2018 36 PT.Indofarma Gemfibrozil 300 11 september 2018 37 PT.Indofarma Gemfibrozil 300 11 september 2018 38 Erlimpex Erphamazol 12 AGUSTUS 2018 39 PT. PRATAPA NIRMALA Bisoprolol Fumarate 3 Januari 2019 40 PT. Guardian Pharmatama STENIROL 8 28-10-2018 41 PT. Guardian Pharmatama STENIROL 16 12-08-2018 42 PT. MEPROFARM PROGESTON 8 Oktober 2018 43 PT. NOVELL XEVOLAC 30 september 2018 LABS 44 PT WIDATRA BHAKTI Ringer Lactate 31-10-18 45 PT. Kimia Farma, Jakarta Alprazolam 0,5 mg 31/05/2018 46 PT. Kimia Farma, Jakarta Alprazolam 1 mg (data yang dikirim tidak lengkap, tidak ada informasi tgl berakhir NIE) 47 PT. Kimia Farma, Jakarta EFAVIRENZ 05/12/2018 48 PT. Kimia Farma, Jakarta NEVIRAPINE 16/09/2018 49 PT. INTERBAT LOTASBAT 22 Agustus 2018 50 PT. INTERBAT INCELIN (Dus, 5 ampul @ 2 ml) 27 Agustus 2018
51 PT. INTERBAT TRIAMCORT A 28 Agustus 2018 52 PT. INTERBAT INCELIN 500 (Dus 5 ampul @ 4 ml) 6 Oktober 2018 53 PT. INTERBAT INCELIN 1000 (Dus 5 ampul @ 8 ml) (data yang dikirim tidak lengkap, tidak ada informasi tgl berakhir NIE) 54 PT. INTERBAT CEPTIK 200 3 November 2018 55 PT. Pratapa Nirmala Iretensa 27-02-2019 56 PT Actavis Indonesia Actoplatin 15-09-2018 (Dus, 1 vial @ 15 ml) 57 PT Actavis Indonesia Actoplatin 15-09-2018 (Dus, 1 vial @ 45 ml) 58 PT Caprifarmindo DENUFAM 20 09-09-2018 59 PT. Sanbe Farma SANROXA 26 Agustus 2018 60 PT. Sanbe Farma OXALIPLATIN 26 Agustus 2018 61 PT. Sanbe Farma LEVOCIN 28 Agustus 2018 62 PT. GUARDIAN CIFLOS 500 10 Oktober 2018 PHARMATAMA 63 PT. GUARDIAN ZIBRAMAX 11 Oktober 2018 PHARMATAMA 64 PT. GUARDIAN AZITHROMYCIN DIHYDRATE 19 Agustus 2018 PHARMATAMA 65 PT. GUARDIAN MAXIFLON 8 Oktober 2013 PHARMATAMA 66 PT. BERNOFARM PANTOPRAZOLE SODIUM 29-05-2018 SESQUIHYDRATE 67 PT. BERNOFARM PANTOTIS 29-05-2018 68 PT. NATURA LABORATORIA PANTOPRAZOLE SODIUM 29-05-2018 SESQUIHYDRATE 69 PT. NATURA LABORATORIA PANTOTUM 29-05-2018 70 PT. INFION FIOPRAZ 29-05-2018 71 PT CAPRIFARMINDO INFUCAP RING-AS 11-06-2018 72 PT Tunggal Idaman Abdi Obat Suntik KB 1 (Tiga Bulanan) 05-06-2018 73 PT. GLOBAL MULTI SPASHI PLUS 08-04-2018 PHARMALAB 74 PT Yarindo Farmatama DOMESONE 09-07-2018 75 PT. NATURA LABORATORIA RANITIDINE HCL 22 April 2018 76 PT. KIMIA, ISONAT 30 MARET 2018 BANDUNG 77 PT. SAMPHARINDO PROAST 07-03-2018 PERDANA 78 PT. PYRIDAM Tbk. COSTIL 11-08-2018 79 PT. Graha Farma FLUCADEX 04-04-2018 80 PT. Graha Farma GRAXINE 04-04-2018 81 PT SANBE MEFUROSAN 25/07/18 82 PT CAPRIFARMINDO LABS CARDICAP 5 06-09-2018 83 PT Sanbe Farma POLIFRISIN 28 Agustus 2018 84 PT CAPRIFARMINDO LABS SANORINE (BARLEY MINT) 80 ml 12-09-2018 85 PT CAPRIFARMINDO LABS SANORINE (BARLEY MINT) 200 ml 12-09-2018 86 PT Sanbe Farma POLIDEMISIN 31-10-2018 87 PT CAPRIFARMINDO LABS TAXECAP 27-12-2018 88 PT. Dankos Farma, Jakarta BENACOL EXPECTORANT 60 ml 31-10-2018 89 PT. Dankos Farma, Jakarta BENACOL EXPECTORANT 100 ml 31-10-2018 90 PT SANBE ROMISAN 2 ml (data yang dikirim tidak lengkap, tidak ada informasi tgl berakhir NIE) 91 PT SANBE ROMISAN 5 ml (data yang dikirim tidak lengkap, tidak ada informasi tgl berakhir NIE) 92 PT SANBE IRINOTECAN HCl 2 ml (data yang dikirim tidak lengkap, tidak ada informasi tgl berakhir NIE) 93 PT SANBE IRINOTECAN HCl 5 ml (data yang dikirim tidak lengkap, tidak ada informasi tgl berakhir NIE) 94 PT Dexa Medica PROPYLTHIOURACIL 27-11-2018 95 PT. Graha Farma ATMACID 60 ml 09-04-2018 96 PT. Graha Farma ATMACID 120 ml 09-04-2018 97 PT. BUFA ANEKA BRAVODERM 9 Desember 2018 98 PT CENDO CATARLENT MD 28-11-2018 99 PT CENDO CATARLENT (5 ml) 28-11-2018 100 PT CENDO CATARLENT (15 ml) 28-11-2018
101 PT. Sanbe Farma PIBAKSIN 30-09-2018 102 PT Indofarma Tbk ISONIAZID 24 Juni 2018 103 PT IFARS Pharmaceutical Quantidex 09/07/2018 104 PT. Sunthi Sepuri Simeco 19-11-2018 105 PT. Guardian Pharmatama FUNGASOL SS 2% 12 November 2018 106 PT. HARBAT Thiamphenicol 04-03-2018 107 PT. Guardian Pharmatama STENIROL-16 12 Agustus 2018 108 PT. MEPROFARM PROMUBA 5 Desember 2018 109 PT OTTO Pharmaceutical Gerdilium 27 Desember 2018 Industries 110 PT. Otto Pharmaceutical OPIMOX 500 12-10-2018 Industries 111 PT MEPROFARM OXORIL 23-12-2018 112 PT. Tunggal Idaman Abdi Tiacinon 11 Agustus 2018 113 PT.Indofarma INACID 500 16 Januari 2019 114 PT.Indofarma Levofloxacin 500 31 Maret 2019 115 PT Natura Laboratoria Prima MEROPENEM 10-05-2018 116 PT Natura Laboratoria Prima QUAMER 10-05-2018 117 PT. Pharos Indonesia AZTRIN 28-11-2018 118 PT. INFION AZITHROMYCIN DIHYDRATE 10-05-2018 119 PT. L'Essential Esclob 31-10-2018 120 PT TROPICA MAS Resubmit TD OBH TROPICA 11-06-2018 S EXPECTORANT Rasa Madu 121 PT. Phapros, Tbk Amoxicillin 250 SK 10-12-2018 122 PT. Phapros, Tbk Hustab P 23-12-2018 123 PT. NICHOLAS INDONESIA POLYCROL 400 29 MEI 2018 124 PT. NICHOLAS POLYCROL 22 JULI 2018 INDONESIA 125 PT. Tempo Scan Pacific Tbk BODREXIN DEMAM (RASA JERUK) 13 Maret 2019 126 PT. Supra Ferbindo Farma CONTREXYN DEMAM (RASA JERUK) 14 Maret 2019 127 PT Novell Pharmaceutical PIRACETAM 19 JUNI 2018 128 PT Novell Pharmaceutical CETIRIZINE DIHYDROCHLORIDE 29 MEI 2018 129 PT. Combiphar MUCOTEIN 10-12-2018 130 PT Pyridam Farma Tbk PYXIME 12 Agustus 2018 131 PT Pyridam Farma Tbk. PREDNOX 04 Nopember 2018 132 PT. INFION AZITHROMYCIN DIHYDRATE 10-05-2018 133 PT. GLOBAL MULTI GAREXIN salep mata PHARMALAB 08-04-2018 134 PT. GLOBAL MULTI GAREXIN tetes mata PHARMALAB 08-04-2018 135 PT. GLOBAL MULTI NEUROTROPIC PHARMALAB 08-04-2018 136 PT MEDI ALAXAN (Khusus Ekspor) 1, 10 & 50 BLISTER 18 Nopember 2018 137 SIMEX MAXPRINOL 22-08-2018 138 PT PHAPROS AMOXICILLIN serbuk injeksi 07-03-2019 139 PT Darya-Varia Laboratoria OZID Tbk 27 Desember 2018 140 PT Darya-Varia Laboratoria ODACE Tbk 22 November 2018 141 PT. Dexa Medica QUIDEX 27 November 2018 142 PT. SAMPHARINDO PROAST PERDANA 07-03-2018 143 PT. MEDIKON FENOFIBRATE 05-05-2018 144 PT DEXA MEDICA CEFPIROME SULFATE 02-10-2018 145 PT PABRIK PHARMASI BEREA ZENITH 23-12-2018 146 PT Guardian Pharmatama PANTOPRAZOLE SODIUM 12-08-2018 147 PT COMBIPHAR DOBUTAMINE - HAMELN 27-12-2018 148 PT. BUFA ANEKA BRAVODERM 9 Desember 2018 149 PT. GUARDIAN STENIROL 4 PHARMATAMA 28 Oktober 2018 150 PT. Marin Liza Farmasi PHYTOMENADION 22-04-2018
151 PT. SOLAS LANGGENG DROXAL (RESUBMITE) suspensi kering SEJAHTERA 125 mg/5 ml 09-02-2018 152 PT. SOLAS LANGGENG DROXAL (RESUBMITE) kapsul SEJAHTERA 09-02-2018 153 PT. SOLAS LANGGENG DROXAL FORTE (RESUBMITE) SEJAHTERA suspensi kering 250 mg/5 ml 09-02-2018 154 PT. SOLAS LANGGENG SOLANEURON SEJAHTERA 05-06-2018 155 PT ERLIMPEX LORIHIS 13-08-2018 156 PT. MEDIKON 30-04-2018 157 PT. CORSA INDUSTRIES CORSTANAL 02-05-2019 158 PT. GLOBAL MULTI NEUROTROPIC PHARMALAB 08-04-2018 159 PT.Pertiwi Agung ULVICE 30 september 2018 160 PT. MERSI TM LEVOBEN 12-08-2018 161 PT ERLIMPEX ERPRAZOL 31-05-2018 162 PT. PERTIWI AGUNG WIACID 23 Desember 2018