REGISTRASI VARIASI OC
No. Tanggal Pelayanan Pendaftar Produk Estimasi Jam
Pelayanan 1 Senin, 05 Juni 2017 PT. Indofarma, tbk Sodium Diklofenak tablet
salut enterik
08.30 2 Senin, 05 Juni 2017 PT. Indofarma cyanocobalamin 09.00
3 Senin, 05 Juni 2017 PT. Graha Farma PRO ATP 09.30
4 Senin, 05 Juni 2017 PT. Pratapa Nirmala, Tangerang
CALLUSOL 10.00
5 Senin, 05 Juni 2017 PT PRATAPA NIRMALA Bromhexine HCl 10.30
6 Senin, 05 Juni 2017 PT. Metiska Farma ASAMNEX 11.00
7 Senin, 05 Juni 2017 PT. Darya-Varia Laboratoria Tbk
ketorolac tromethamol 12.30 8 Senin, 05 Juni 2017 PT Combiphar Somatostatin Lyomark 13.00 9 Senin, 05 Juni 2017 PT. Promedrahardjo FI AMLODIPINE 10 13.30 10 Senin, 05 Juni 2017 PT. Promedrahardjo FI AMLODIPINE 5 14.00
No. Tanggal Pelayanan Pendaftar Produk Estimasi Jam
Pelayanan
1 Selasa, 06 Juni 2017 PT Kalbe Farma Pranza 08.30
2 Selasa, 06 Juni 2017 PT. Kalbe Farma Tbk., Bekasi
Sterile Water for Injection 09.00 3 Selasa, 06 Juni 2017 PT OTSUKA INDONESIA MEYLON-84 BP 09.30 4 Selasa, 06 Juni 2017 PT. Mahakam Beta Farma,
Jakarta
Betadine Feminine Hygiene 10.00 5 Selasa, 06 Juni 2017 PT. Mahakam Beta Farma,
Jakarta
Betadine Feminine Hygiene 10.30 6 Selasa, 06 Juni 2017 PT. Solas Langgeng
Sejahtera
SINTROL 11.00
7 Selasa, 06 Juni 2017 PT Guardian Pharmatama Glamarol 1 dan Generiknya 12.30 8 Selasa, 06 Juni 2017 PT Guardian Pharmatama Glamarol 4 dan Generiknya 13.00
9 Selasa, 06 Juni 2017 PT BIO KUSUMA Biogen 13.30
10 Selasa, 06 Juni 2017 PT BIO KUSUMA Biogen Forte 14.00 JADWAL PELAYANAN REGISTRASI
RESUBMIT VARIASI OC
No. Tanggal Pelayanan Pendaftar Produk Estimasi Jam
Pelayanan 1 Senin, 05 Juni 2017
PT. Natura Laboratoria Prima PARACETAMOL & BRAND
08.30 2 Senin, 05 Juni 2017 09.00 3 Senin, 05 Juni 2017 09.30 4 Senin, 05 Juni 2017 10.00 5 Senin, 05 Juni 2017 10.30 6 Senin, 05 Juni 2017 11.00 7 Senin, 05 Juni 2017 12.30 8 Senin, 05 Juni 2017 13.00 9 Senin, 05 Juni 2017 13.30 10 Senin, 05 Juni 2017 14.00
No. Tanggal Pelayanan Pendaftar Produk Estimasi Jam
Pelayanan 1 Selasa, 06 Juni 2017 08.30 2 Selasa, 06 Juni 2017 09.00 3 Selasa, 06 Juni 2017 09.30 4 Selasa, 06 Juni 2017 10.00 5 Selasa, 06 Juni 2017 10.30 6 Selasa, 06 Juni 2017 11.00 7 Selasa, 06 Juni 2017 12.30 8 Selasa, 06 Juni 2017 13.00 9 Selasa, 06 Juni 2017 13.30 10 Selasa, 06 Juni 2017 14.00
RENEWAL OC
No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir
NIE 1 Senin, 05 Juni 2017 PT. Hexpharm Jaya CAPTOPRIL 12,5 27-Aug-17 2 Senin, 05 Juni 2017 PT. Hexpharm Jaya, Bekasi DANASONE 12-Sep-17 3 Senin, 05 Juni 2017 PT. Phapros, Tbk Ecosol NaCl 05-Sep-17 4 Senin, 05 Juni 2017 PT. Phapros, Tbk Ecosol G5 05-Sep-17
5 Senin, 05 Juni 2017 PT Indofarma Lincomycin 06-Sep-17
6 Senin, 05 Juni 2017 PT. Indofarma Gemfibrozil 06-Sep-17
7 Senin, 05 Juni 2017 PT Indofarma ACYCLOVIR 400 12-Sep-17 8 Senin, 05 Juni 2017 PT Indofarma ACYCLOVIR 200 12-Sep-17 9 Senin, 05 Juni 2017 PT. PERTIWI AGUNG LAMETIC 4 12-Sep-17 10 Senin, 05 Juni 2017 PT. PERTIWI AGUNG LAMETIC 8 12-Sep-17
No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir
NIE
1 Selasa, 06 Juni 2017 PT Sanbe Farma FUNTAS 06-Sep-17
2 Selasa, 06 Juni 2017 PT Sanbe Farma Gemcitabine 200 3 Selasa, 06 Juni 2017 PT Sanbe Farma Biothicol 250 4 Selasa, 06 Juni 2017 PT. TUNGGAL IDAMAN
ABDI
CYCLOFEM suspensi injeksi 12-Sep-17 5 Selasa, 06 Juni 2017 PT. TUNGGAL IDAMAN
ABDI
CYCLOFEM 12-Sep-17
6 Selasa, 06 Juni 2017 PT. Hexpharm Jaya CETIRIZINE HCL 12-Sep-17 7 Selasa, 06 Juni 2017 PT. Hexpharm Jaya, Bekasi Forten 12.5 12-Sep-17 8 Selasa, 06 Juni 2017 PT GRACIA PHARMINDO GRAPHALAC
12-Sep-17 9 Selasa, 06 Juni 2017 PT BUFA ANEKA EKACETOL 500 25-Sep-17
10 Selasa, 06 Juni 2017 PT BUFA ANEKA TEAMIC 25-Sep-17
No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir
NIE
1 Rabu, 07 Juni 2017 PT. INTERBAT TRIAMCORT 25-Sep-17
2 Rabu, 07 Juni 2017 PT. INTERBAT INTERZOL 15-Oct-19
3 Rabu, 07 Juni 2017 PT Kalbe Farma POVIRAL 01-Oct-17
4 Rabu, 07 Juni 2017 PT. Mahakam Beta Farma VOMETRON 8 01-Oct-17 5 Rabu, 07 Juni 2017 PT. Mahakam Beta Farma VOMETRON 4 01-Oct-17 6 Rabu, 07 Juni 2017 PT Nufarindo Gitaramin kaptab salut
selaput
01-Oct-17
7 Rabu, 07 Juni 2017 PT Nufarindo Gitaramin 02-Oct-17
8 Rabu, 07 Juni 2017 Erlimpex erphatrim forte 04-Oct-17
9 Rabu, 07 Juni 2017 PT Ferron Par Pharmaceuticals
Tenapril 2.5
05-Oct-17 10 Rabu, 07 Juni 2017 PT Ferron Par
Pharmaceuticals
Tenapril 5
05-Oct-17
No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir
NIE 1 Kamis, 08 Juni 2017 PT.Indofarma Metronidazole 500 mg 23-Apr-17 2 Kamis, 08 Juni 2017 PT Indofarma Doxyxycline Hyclate 08-Oct-17
3 Kamis, 08 Juni 2017 PT Indofarma Mineral Mix 03-Oct-17
4 Kamis, 08 Juni 2017 PT Nufarindo Stavit 18-Oct-17
5 Kamis, 08 Juni 2017 PT. PERTIWI AGUNG cimetidine 03-Aug-17 6 Kamis, 08 Juni 2017 PT. PERTIWI AGUNG LAMETIC 4 12-Sep-17 7 Kamis, 08 Juni 2017 PT. PERTIWI AGUNG lametic 8 12-Sep-17
8 Kamis, 08 Juni 2017 PT Harsen Decamox 16-Jul-17
9 Kamis, 08 Juni 2017 PT Harsen Decamox Forte 18-Jul-17
CADANGAN REGISTRASI VARIASI OC
No. PENDAFTAR NAMA OBAT
1 PT. GUARDIAN PHARMATAMA
NALETAL 100 2
3 PT. Hexpharm Jaya Bintamox DS
4 PT. Hexpharm Jaya Amoxicillin Trihydrate 5 PT. Hexpharm Jaya ONDANSETRON HCL 2 ML 6 PT. Hexpharm Jaya ONDANSETRON HCL 4 ML 7 PT. Triyasa Nagamas Farma Deponeo 3 ; Obat Suntik KB
1 Tiga Bulanan 8 PT. Promedrahardjo FI LORATADINE 9 PT. Solas Langgeng
Sejahtera
SINTROL
10 PT. PHAROS INDONESIA POLYSILANE KAPSUL 11 PT Yarindo Farmatama Novaldo
12 PT OTTO Pharmaceutical Industries
Pelarut Omeprazole 13 PT Dexa Medica Ramipril OGB 2,5 MG 14 PT Dexa Medica Ramipril OGB 5 MG 15 PT Dexa Medica Hyperil 2.5
16 PT Dexa Medica Hyperil 5 17 PT Ferron Par Pharmaceuticals Tenapril 2.5 18 PT Ferron Par Pharmaceuticals Tenapril 5 19 PT. Dexa Medica Spironolactone 20 PT. Ethica Industri Farmasi Epinephrine 21 PT.Ethica Industri Farmasi KETOROLAC
TROMETAMOL
22 PT.Ethica Industri Farmasi Ondansetron HCl Dihydrate 2 ML
23 PT.Ethica Industri Farmasi Ondansetron HCl Dihydrate 4 ML
24 PT Soho Industri Pharmasi Ranitidine HCl 25 PT.Ethica Industri Farmasi CETADOP
26 PT HARSEN MOSAVON
27 PT HARSEN GENTANAL
28 PT. Promedrahardjo FI PROPANZOL 29 PT. Kalbe Farma CLAVAMOX 30 PT. MERSIFARMA TM CLONAZEPAM 31 PT.MERSIFARMA TM INHA 400
32 PT BERNOFARM BROXAL 30 MG/5 ML 33 PT BERNOFARM BROXAL 15 MG/5 ML 34 PT. Kalbe Farma V BLOC
35 PT. Dankos Farma Mikasin 250 36 PT. Dankos Farma Mikasin 500 37 PT.MERSIFARMA TM RIKLONA 2
38 PT SANBE FARMA DIALISAN DP-4 2,5% larutan dialisis peritoneal
39 PT. Mahakam Beta Farma Betadine Vaginal Douche 40 PT.TEMPO SCAN PACIFIC DBL Dacarbazine serbuk
injeksi
41 DEXA MEDICA CEFRATAM serbuk injeksi 42 Dexa Medica CEFOPERAZONE
SULBACTAM serbuk injeksi 43 PT. Mahakam Beta Farma Ondansetron HCl injeksi 44 PT. Pratapa Nirmala SOJOURN cairan inhalasi 45 PT HARSEN FUSALTRAX sirup kering 46 PT Pyridam Farma Tbk Vibramox sirup kering 47 PT. Mahakam Beta Farma VASODRIN injeksi 48 PT. Mahakam Beta Farma EPHEDRINE HCl injeksi 49 PT Lapi Laboratories Cravox
50 PT Dexa Medica Furosemide 51 PT. Dexa Medica CEFRATAM
52 PT. Dexa Medica Cefoperazone Sulbactam
53 PT HARSEN DECATONA
54 PT. Indofarma, tbk Sodium Diclofenak
55 PT HARSEN DECATONA 56 57 PT. GLOBAL MULTI PHARMALAB LEFRINA 58 PT HARSEN DINASEPT 59
PT. TRIMAN GLYCERYL GUAIACOLATE 60 PT. Dexa Medica KETOROLAC TROMETHAMINE 1% 61 PT. Combiphar
OBH Combi Batuk Plus Flu (Rasa Jahe)
62
Dexa Medica
KETOROLAC TROMETHAMINE 3% 63 Dexa Medica REMOPAIN 1% 64 Dexa Medica REMOPAIN 3% 65
PT. Triyasa Nagamas Farma Tranabat 66
PT. Triyasa Nagamas Farma Tranaflu
67 PT. Bernofarm LIDODEX SPINAL HEAVY 68 Fresenius Kabi Combiphar Fresofol 1% MCT/LCT 69 PT. Kimia Farma, Jakarta CEFADROXIL
70 PT. Indofarma,tbk Sodium Diklofenac 71 PT OTTO Pharmaceutical
Industries OMEPRAZOLE SODIUM
72 PT. PERTIWI AGUNG Lanamol 73 PT. PERTIWI AGUNG Ulvice
CADANGAN RENEWAL OC
No. PENDAFTAR NAMA OBAT TANGGAL BERAKHIR NIE
1 PT PABRIK PHARMASI ZENITH
FLUMIN PLUS
30-Oct-17 2 PT Soho Industri Pharmasi Cedantron 30-Oct-17
3 PT GRACIA PHARMINDO ZEMINDO 30-Oct-17
4 PT.Ethica Industri Farmasi PECTOCIL DS 30/10/2017
5 PT Kalbe Farma Gemcikal 200 mg 30-Oct-17
6 PT Kalbe Farma Gemcikal 1000 mg 30-Oct-17
7 PT. Hexpharm Jaya TIBIGON 05-Nov-17
8 PT Guardian Pharmatama Cefixime trihydrate 12-Nov-17
9 PT. PHAROS INDONESIA OZEN 12-11-2017
10 PT Ikapharmindo Putramas Lactulax sirup 13-11-2017 11 PT. IKAPHARMINDO
PUTRAMAS
IKANEURON 5000 injeksi 13-11-2017
12 PT.Promedrahardjo FI Ranitidin 13-11-2017
13 PT Galenium Pharmasia lab CALACORT
14-Nov-17 14 PT.Pharos Indonesia Ascardia tablet salut enterik
80
14-11-2017 15 PT.Pharos Indonesia Ascardia tablet salut enterik
160
14-11-2017
16 PT Indofarma Furosemide 12 November 2017
17 PT MEPROFARM INTUNAL 12 NOVEMBER 2017
18 PT. Pratapa Nirmala Granisetron 1 13 November 2017
19 PT. PRATAPA NIRMALA BIPRO 17 November 2017
20 PT Kalbe Farma provelyn 75 23 November 2017
21 PT Kalbe Farma Provelyn 150 23 November 2017 22 PT. Pratapa Nirmala Renagas 30 November 2017
23 PT. Kalbe Farma Kalbutol 5 November 2017
24 PT Indofarma Indoralyt 8 November 2017
25 PT. PRATAPA NIRMALA DEGRANI 3 + GENERIK 13 NOVEMBER 2017 26 PT. IKAPHARMINDO PUTRAMAS Pantoprazole 23-11-2017 27 PT. IKAPHARMINDO PUTRAMAS PANDECTA 23-11-2017
28 PT. Dexa Medica Glumin XR 29-11-2017
29 PT Ikapharmindo Putramas AQUA PRO INJECTION 29-11-2017
30 PT Indofarma Erithromycin 3 Desember 2017
31 PT. Kalbe Farma Mycoral 15 G & 5 G 05-Dec-17
32 PT MEPROFARM PYREXIN 80 5 DESEMBER 2017
33 PT MEPROFARM PYREXIN 160 5 DESEMBER 2017
34 PT MEPROFARM PYREXIN 80 5 Desember 2017
35 PT Ferron Trixim kapsul 100 10-Dec-17
36 PT Ferron Trixim sirup kering 10-Dec-17
37 PT. Dipa Pharmalab Intersains
Molesco 5 10 Desember 2017
38 PT. Roi Surya Prima Farma SKINOVIT 14-12-2017 39 PT. Hexpharm Jaya, Bekasi Lambucid 17 Dec 2017 40 PT. SAMPHARINDO
PERDANA
CALKOMIR 21-12-2017
41 Konimex Inzana 26-Dec-17
42 TROPICA MAS PHARMACEUTICALS TROVIAKOL 31-Dec-17 43 TROPICA MAS PHARMACEUTICALS ZULTROP KAPTAB 31-Dec-17 44 TROPICA MAS
PHARMACEUTICALS ZULTROP FORTE 31-Dec-17
45 Konimex DIPROSTA 31-Dec-17
46 Konimex ASKAMEX 31-Dec-17
47
PT. Combiphar Iron (III)-Hydroxide Polymaltose Complex ~ Iron (III) 100 mg
48 PT. METISKA FARMA XEPANEURON 31-Dec-17 49 TROPICA MAS PHARMACEUTICALS PYCAMETH 31-Dec-17 50 TROPICA MAS PHARMACEUTICALS ZULTROP SUSPENSI 31-Dec-17
51 PT. Kalbe Farma Anaprin 31-Dec-17
52 PT. Phyto Kemo Agung Farma
Isoniazid tablet 100 31 Desember 2017 53 PT. Phyto Kemo Agung
Farma
Isoniazid tablet 300 31 Desember 2017 54 PT. Pratapa Nirmala,
Tangerang
FIXACEP 200 31 Desember 2017
55 PT. Metiska Farma Penagon 31 Desember 2017
56 PT. Metiska Farma Cough En Plus 31 Desember 2017 57 PT. Supra Ferbindo Farma OSKADON 31 Desember 2017 58 PT.Ethica Industri Farmasi CETADOP 31-12-17 59 PT Combiphar X-Flam tablet salut gula 31-12-2017 60 PT Holi Pharma IBUPROFEN kaptab 31-12-2017 61 PT. Pharos Indonesia liposin salep 31-12-2017 62 PT. Pharos Indonesia Biostatik tablet salut selaput 31-12-2017 63 PT. Universal Pharmaceutical
Industries
Antasida Doen tablet 31-12-2017 64 PT. Rama Emerald Multi
Sukses
Eryra 31-12-2017
65 PT. NOVAPHARIN Metamizole Sodium 31-12-2017
66 PT. NOVAPHARIN Novaron 31-12-2017
67 PT. PHAROS INDONESIA POLYSILANE 100 ML 31-12-2017
68 PT Combiphar Promactil 31-12-2017
69 PT. PHAROS INDONESIA POLYSILANE 100 ML 31-12-2017 70 PT. PHAROS INDONESIA POLYSILANE 100 ML 31-12-2017
71 PT. Pratapa Nirmala Nokoba 31-12-2017
72 PT. Pratapa Nirmala Laxasium 31-12-2017
73 PT. Pratapa Nirmala Nasaflam 50 31-12-2017 74 PT ETHICA INDUSTRI FARMASI METHYLERGOMETRINE MALEATE 31-12-2017 75 PT ETHICA INDUSTRI FARMASI MYOMERGIN 31-12-2017 76 PT ETHICA INDUSTRI FARMASI ETHIFERAN 31-12-2017 77 PT ETHICA EPINEPHRINE 31-12-2017
78 PT ETHICA CALCIUM GLUCONATE 31-12-2017
79 PT. Berlico Mulia Farma LICOKLOR 31-12-2017
80 PT Combiphar Ribunal 31-12-2017
81 PT. Roi Surya Prima Farma SKINOVIt 04-01-2018 82 PT. IMMORTAL
PHARMACEUTICAL LABORATORIES
NYGROX 18-01-2018
83 PT Lucas Djaja Gliserol
84 Erela chloramphenicol 31-12-2017
85 Erela alletrol 31-12-2017
86 PT Lapi Laboratories Lapimox 125 3 Oktober 2017 87 PT Lapi Laboratories Lapimox 250 3 Oktober 2017
88 PT. Imedco Djaja BRONKIPECT 31-dec-17
89 PT. IMEDCO DJAJA CYMALIUM-10 31-DEC-17
90 PT. IMEDCO DJAJA MEDTYAPHEN 31-DEC-17
91 Erela new ascaps 31-12-2017
92 Erela sulfacetamid 31-12-2017
93 PT AFIFARMA GLISERIN 31-12-2017
94
95 PT AFIFARMA GLISERIN 31-12-2017
96 PT. Ikapharmindo Putramas Aqua Pro Injection 29 November 2017
98 PT AFIFARMA GLISERIN 31-12-2017
99 PT AFIFARMA GLISERIN 31-12-2017
100 PT AFIFARMA GLISERIN 31-12-2017
101 PT AFIFARMA GLISERIN 31-12-2017
102 PT. Ikapharmindo Putramas Edemin 31 Desember 2017
103 PT. NOVAPHARIN Novabiotic 31-12-2017
104 PT. NOVAPHARIN Clorampenicol 31-12-2017
105
PT Medifarma Laboratories ENZYPLEX (Khusus Ekspor) 12-11-2017 106 PT. Roi Surya Prima Farma SKINOVIT 14-12-2017 107 PT. Futamed Pharmaceuticals FUDO 27-09-2017 108 PT. Futamed
Pharmaceuticals FUTAPIM 03-10-2017
109 PT. IMEDCO DJAJA BRONKIPECT 31 DECEMBER 2017 110 PT.Sejahtera Lestari Farma Selespurin 300 11-06-2017
111 PT. Dankos Farma Transmuco 31 -12-2017
112 PT. IMEDO DJAJA CYMALIUM-10 31 DECEMBER 2017 113 PT. IMEDCO DJAJA MEDTYAPHEN-500 31 DECEMBER 2017
114 Dexa Medica PRONALGES 10-12-2017
115 PT.Dexa Medica VECTRINE 31-12-2017
116 PT. Ferron Par Pharmaceuticals GRAVOMIT 14-11-2017 117 Guardian Pharmatama NUCOLINE Injeksi (4 ml&8ml) 25-09-2017 118
PT. Triyasa Nagamas Farma Valenor 2 05-09-2017
119 Guardian Pharmatama PANTERA 03-12-2017
120 PT. TRIFA RAYA
LABORATORIES Trifastan 14-11-2017
121 PT. Tempo Scan Pacific DBL Oxaliplatin 7 Maret 2018
122 PT. PHAROS INDONESIA AVOCEL 27-08-2017
123
124 PT. Tempo Scan Pacific DBL Oxaliplatin 100 7 Maret 2018
125 PT. PHAROS INDONESIA AVOCEL 27-08-2017
126 PT MEPROFARM INTUNAL 12 NOPEMBER 2017
127 PT MEPROFARM PYREXIN 80 5 DESEMBER 2017
128 PT. Ikapharmindo Putramas ULSICRAL 09-10-2017 129 PT. Ikapharmindo Putramas PANTOPRAZOLE 23-11-2017 130 PT. Ikapharmindo Putramas PANDECTA 23-11-2017
131 PT Harsen LOPAMID 4-10-2017
132 PT. Pratapa Nirmala,
Tangerang PRATROPIL Syrup 03 Desember 2017
133 PT. Pratapa Nirmala Nasaflam 100 31-12-2017 134 PT. Imfarmind Farmasi
Industri Metamizole Sodium 2 agustus 2017
135 PT. Imfarmind FI Paracetamol 2-08-2017
136 PT. Imfarmind FI IFISON 31-12-2017
137 PT. SUMBER KESEHATAN BARU
Puder Obat Sakit Kepala
cap"38" 31-12-2017
138 PT. Imfarmind FI Chloramphenicol 31-12-2017
139 PT. Mersifarma LODOMER 8 nopember 2017
140 PT. Mersifarma LODOMER 8 nopember 2017
141 TROPICA MAS
PHARMACEUTICALS LOVITROP 142 TROPICA MAS
PHARMACEITICALS TROPIGESIC 31 DESEMBER 2017
143 TROPICA MAS
PHARMACEUTICALS TROPIGESIC 31 DESEMBER 2017
144 PT NOVELL
PHARMACEUTICAL LAB OREZINC 27 AGUSTUS 2017
145 PT NOVELL
PHARMACEUTICAL LAB ORNISPAR 26 SEPTEMBER 2017