REGISTRASI VARIASI OG (BERKAS BARU DAN RESUBMIT)
Senin, 24 Desember 2018 CUTI BERSAMA NATAL 2018
Selasa, 25 Desember 2018 HARI RAYA NATAL 2018
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."
Tanggal Pelayanan KETERANGAN
RENEWAL OG
No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir NIE
1 Rabu, 26 Desember 2018 PT Dexa Medica PROBENID 12-12-2019
2 Rabu, 26 Desember 2018 PT Otsuka Indonesia OTSU-D5, NS 02-10-2019
3 Rabu, 26 Desember 2018 PT IFARS Pharmaceutical
Laboratories Amlodipine besilate 22-10-2019
4 Rabu, 26 Desember 2018 PT IFARS Pharmaceutical
Laboratories Zevask 10 22-10-2019
5 Rabu, 26 Desember 2018 PT. TRIMAN PREDNISONE 17/11/2019
6 Rabu, 26 Desember 2018 PT. TRIMAN CHLORPHENIRAMINE 4 mg 17-11-2019
7 Rabu, 26 Desember 2018 PT.Indofarma captopril 25 (resubmit) 29-05-2019
8 Rabu, 26 Desember 2018 PT. BERNOFARM FENAREN 07-09-2019
9 Rabu, 26 Desember 2018 PT. Bernofarm PHENOBIOTIC 08-06-2019
10 Rabu, 26 Desember 2018 PT. BERNOFARM Allopurinol 09-07-19
No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir NIE
1 Kamis, 27 Desember 2018 Taisho Pharmaceutical Indonesia Ambroxol HCl sirup 15 16-05-2019 2 Kamis, 27 Desember 2018 Taisho Pharmaceutical Indonesia Ambroxol HCl sirup 30 16-05-2019 3 Kamis, 27 Desember 2018 Taisho Pharmaceutical Indonesia Ambroxol HCl drops 16-05-2019 4 Kamis, 27 Desember 2018
PT. PERTIWI AGUNG Lantiflam 50 23 Desember 2018
5 Kamis, 27 Desember 2018
PT. PERTIWI AGUNG Lantiflam 100 23 Desember 2018
6 Kamis, 27 Desember 2018
PT Novell Pharmaceutical Lab Bisoprolol Fumarate 27-12-18
7 Kamis, 27 Desember 2018 PT SANBE FARMA CEFTRIAXONE SODIUM 06-01-2019
8 Kamis, 27 Desember 2018 PT. Sanbe Farma BAQUINOR FORTE 16 Januari 2019
9 Kamis, 27 Desember 2018 PT. Sanbe Farma DILTIAZEM HCl (Resubmit) 31 Desember 2017
10 Kamis, 27 Desember 2018 PT. Kimia Farma, Bandung ALLOPURINOL 20-12-2019
Senin, 24 Desember 2018 CUTI BERSAMA NATAL 2018
Selasa, 25 Desember 2018 HARI RAYA NATAL 2018
Tanggal Pelayanan KETERANGAN
No. PENDAFTAR NAMA OBAT
1 PIM Pharmaceuticals Analpim
2 PT. Pabrik Pharmasi Zenith FLAZEN
3 PT. BUFA ANEKA Bufagan
4 PT. Pabrik Pharmasi Zenith zentarin
No. PENDAFTAR NAMA OBAT
1 PT. Pharos Indonesia KOLTON 300
2 PT Pharos Indonesia Rozgra
3 PT Pharos Indonesia Rozgra
4 PT DARYA-VARIA LABORATORIA EPIFRI
5 PT. Dexa Medica PIRACETAM
6 PT. Dexa Medica PIRACETAM
7 PT. Ferron Par Pharmaceuticals FEPIRAM 8 PT. Rama Emerald Multi Sukses Ramahist 9 PT. PRATAPA NIRMALA stabactam 10 PT. Pratapa Nirmala N-Ace 11 PT. Marin Liza Farmasi Folic Acid 12 PT. Promedrahadrjo FI Prolecin 13 PT. Gracia Pharmindo GRATAMIN 14 PT. Pratapa Nirmala Venodenol 3%
15 PT. Fresenius Kabi Combiphar FRESOFOL 1% MCT/LCT
16 PT. Fresenius Kabi Combiphar FRESOFOL 1% MCT/LCT 17 PT. MAHAKAM BETA FARMA Nexigas
18 PT. MAHAKAM BETA FARMA Esomeprazole Sodium 19 PT IFARS Pharmaceutical Laboratories Roverton
20 PT. SAMCO FARMA SAMCONAL
21 PT. SAMCO FARMA SAMCONAL
22 PT. PHAROS INDONESIA PRAXION FORTE 23 PT. PHAROS INDONESIA PRAXION 120 24 PT. Pratapa Nirmala SHAROX 750 25 PT. PRATAPA NIRMALA Thromboflash 26 PT. Pratapa Nirmala RENALYTE 27 PT Yarindo Farmatama Haloperidol 28 PT Yarindo Farmatama Haloperidol 29 PT Yarindo Farmatama Haloperidol 30 PT. BAYER INDONESIA Saridon
31 PT. Hexpharm Jaya Amoxicillin Trihydrate
32 PT Kalbe Farma ANGIOTEN
CADANGAN REGISTRASI VARIASI OG CADANGAN RESUBMIT VARIASI OG
CADANGAN REGISTRASI ULANG
No. Pendaftar Produk Tanggal Berakhir NIE
1 PT OTSUKA INDONESIA Obucort Swinghaler 28-Apr-19 Ke SubDit Obat Baru
2 PT OTSUKA INDONESIA Meptin Swinghaler 28-Apr-19 Ke SubDit Obat Baru
3 GRACIA PHARMINDO VOMISTOP 03-Mar-17 daftar ke OG
4 PT. Pabrik Pharmasi Zenith Coldrexin Expectorant dan Pilek 22-Apr-18 daftar ke OG 5 PT. Galenium Pharmasia Laboratiries Neladryl Expectorant 31-01-2018 daftr ke OG
6 PT. PHAROS INDONESIA CHOLESPAR 10 31 DESEMBER 2017 daftr ke OG
7 PT. PHAROS INDONESIA CHOLESPAR 20 31 DESEMBER 2017 daftr ke OG
8 PT Lapi Laboratories CRAVOX 500 27-06-2019
9 PT. DANKOS FARMA Neciblok 15-06-2019
10 PT Lapi Laboratories Movix-7.5 22 November 2019
11 PT Lapi Laboratories Movix 15 22 November 2019
12 PT. SAMPHARINDO PERDANA SIOBION 7 AGUSTUS 2019
13 Erlimpex kapedoxin (strip) 31-05-2019
14 Erlimpex kapedoxin (botol) 31-05-2019
15 PT Ferron Par Pharmaceuticals TRIXIM 200 27 Juni 2019
16 PT. COMBIPHAR MALTOFER 7 September 2019
17 PT. INTERBAT Amlodipine Besylate 5 10 Februari 2019
18 PT. INTERBAT Amlodipine Besylate 10 10 Februari 2019 19 PT. Kimia Farma, Bandung MIKRODIOL 30 (catch cover) 04-08-2019 20 PT. Kimia Farma, Bandung MIKRODIOL 30 (100 blister) 04-08-2019 21 PT. Kimia Farma, Bandung Pil KB I Kombinasi 27-11-2019
22 PT Meprofarm SUPRAMOX 11-08-2019
23 PT Meprofarm ARSINAL 04-08-2019
24 Erlimpex stanalin ds 08-06-2019
25 PT. Ferron Par Pharmaceuticals HISTRINE 13-04-2019
26 PT. Kalbe Farma, Tbk Paxus 30 12 Aug 2019
27 PT KONIMEX SILADEX® MUCOLYTIC &
EXPECTORANT 30 ml 06-04-2019
28 PT KONIMEX SILADEX® MUCOLYTIC &
EXPECTORANT 60 ml 06-04-2019
29 PT KONIMEX SILADEX® MUCOLYTIC &
EXPECTORANT 100 ml 06-04-2019 30 PT KONIMEX SILADEX® COUGH & COLD 30 ml 06-04-2019 31 PT KONIMEX SILADEX® COUGH & COLD 60 ml 06-04-2019
32 Erlimpex momet 11-12-2019
33 Erlimpex neo kaocitin 11-12-2019
34 Erlimpex erphapain 02-12-2019
35 PT. Bernofarm ANAFEN 27-06-2019
36 PT. DEXA MEDICA DEXA - M 05-09-2019
37 PT. NOVAPHARIN ANTASIDA DOEN 13-05-2019
38 PT. Pratapa Nirmala FARPAIN 30 02-12-2019
39 PT. SOLAS LANGGENG SEJAHTERA Nootrisol 27-06-2019
40 PT NUFARINDO NUFADEX M 08-06-2019
41 PT. Pratapa Nirmala FARPAIN 30 02-12-2019
42 PT. Ferron Par Pharmaceuticals AFUCID 25-06-2019
43 PT. NOVAPHARIN ANTASIDA DOEN 13-05-2019
44 PT Yarindo Farmatama Isosorbide Dinitrate 12-12-2019
45 PT. Kalbe farma Promag
46 PT. NOVAPHARIN ANTASIDA DOEN 13-05-2019
47 PT. Bernofarm ANAFEN 27-06-2019
48 PT Lapi Laboratories LAPICEF 125 06 OKTOBER 2019
49 PT Lapi Laboratories LAPICEF 250 06 OKTOBER 2019
50 PT BERNOFARM BERSOL (tube @ 5) 04-09-2019
51 PT BERNOFARM BERSOL (tube @ 15) 04-09-2019
52 PT BERNOFARM METHYLPREDNISOLONE 22-09-2019
53 PT. Dexa Medica GLUVAS 1 20 Oktober 2019
54 PT. Dexa Medica GLUVAS 2 20 Oktober 2019
55 PT Harsen harmida 2,5 27 juni 2019
56 PT. NOVAPHARIN ANTASIDA DOEN 13-05-2019
57 PT. SOLAS LANGGENG SEJAHTERA Nootrisol 27-06-2019
58 PT. SOLAS LANGGENG SEJAHTERA FIXAM 31-10-2018 daftr ke OG
59 PT. SOLAS LANGGENG SEJAHTERA FIXAM 31-10-2018 daftr ke OG
60 PT CIUBROS FARMA CETEME 13-09-2019
61 PT. ITRASAL SALTRIM 09-05-2019
62 PT DEXA MEDICA TILFLAM 09 JULI 2019
63 PT. NOVAPHARIN OMEPRAZOLE 09-10-2019
64 PT. DEXA MEDICA GRANON 1 21-08-2019
65 PT. Guardian Pharmatama TRIOCOL 0,25 24 januari 2019
66 PT. Triyasa Nagamas Farma Obatine 20-03-2019
67 PT BERNOFARM RANITIDINE HCl 30-07-2019
68 PT. Lucas Djaja Iglodep 03-02-2019
69 PT. Promedrahadrjo FI Progyl Infus 24 Juni 2019
70 PT. Promedrahadrjo FI Bromedcyl 8 29-07-2019
71 PT. Bernofarm Chloramphenicol 21-09-2019
72 PT. Bernofarm BIOGASTRON 28-02-2019
73 PT. Futamed Pharmaceuticals Epirol 10 27 Februari 2019 74 PT. Futamed Pharmaceuticals Epirol 50 14 Maret 2019
75 PT. Bernofarm THIAMPHENICOL 11-08-2019
76 PT. Bernofarm PHENOBIOTIC 11-08-2019
77 PT. Bernofarm METHYLPREDNISOLONE 22-09-2019
78 PT. Pratapa Nirmala FARMACROL FORTE 24-11-2019
79 PT. FERRON PAR
PHARMACEUTICALS zelface 25 Juni 2019
80 PT. BERNOFARM BERSOL 04-09-2019
81 PT. BERNOFARM BERSOL 04-09-2019
82 PT. BERNOFARM REMATOF 04-10-2019
83 PT. Dexa Medica TILFLAM 09 Juli 2019
84 PT Nufarindo NUFADEX M 08/06/2019
85 PT Nufarindo NUFADEX M 0
86 PT Nufarindo NUFADEX M 08/06/2019
87 PT. PRATAPA NIRMALA -
TANGERANG ATOFAR 20 2 - 7 - 2019
88 PT. PRATAPA NIRMALA -
TANGERANG ATORVASTATIN 20 4-7-2019
89 PT. PHAROS INDONESIA POLYSILAN MAX MINT 31-01-2019
90 PT. Sanbe Farma BETAM-OPHTAL 3 Februari 2019
91 PT.Erlimpex simcef 07-05-2019
92 PT. LUCAS DJAJA RENXON 29 Juli 2019
93 PT PYRIDAM FARMA TBK ULCUSAN 200 24 Februari 2019
94 PT PYRIDAM FARMA TBK OCIDERM-N 27 JULI 2019
95 PT. Dankos Farma, Jakarta URDAHEX 27-06-2019
96 PT. Dankos Farma, Jakarta TOPCILLIN 31-12-2019
97 PT IFARS Pharmaceutical Laboratories Trovilon 07/11/2019
98 PT. BERNOFARM PIRACETAM 1 g/5 ml 05-09-2019
99 PT. BERNOFARM BENOCETAM 1 g/5 ml 05-09-2019
100 PT. BERNOFARM PIRACETAM 3 g/15 ml 05-09-2019
101 PT. BERNOFARM BENOCETAM 3 g/15 ml 05-09-2019
102 PT. BERNOFARM PIRACETAM 05-09-2019
103 PT. Promedrahadrjo FI Ultilar 18-08-2019
104 PT. Promedrahadrjo FI Asam Mefenamat 13-11-2019
105 PT. Promedrahadrjo FI Probion 03-09-2019
106 PT MEPROFARM SUPRAFENID 04-08-2019
107 PT MEPROFARM SUPRAMOX 11-08-2019
108 PT Pyridam Farma Tbk Lecrav 21 Oktober 2019
109 PT. Novell Pharmaceutical Laboratories ERICFIL 100 04-03-2019
110 PT. Caprifarmindo Labs. CIPREC 22 Februari 2018 daftr ke OG
111 PT. MERSIFARMA TM LODOMER DROPS 20-05-2019
112 PT. Pabrik Pharmasi Zenith ZENSODERM 13 Oktober 2019 113 PT. GRATIA HUSADA FARMA HUFAGRIPP PILEK 11-05-2019 114 PT. Novell Pharmaceutical Laboratories BISOVELL 3 JANUARI 2019
115 Erela Chloramphenicol 18 Maret 2020
116 PT. Pratapa Nirmala Xolmetras 350 6 Juni 2019
117 PT Lapi Laboratories Lapibion 17-10-2018 daftr ke OG
118 PT. Kalbe Farma, Tbk Albiotin Acne Solution 17 Nov 2019 119 PT. KIMIA FARMA JAKARTA Kombipak Azithromycin Cefixime 27-06-2019
120 PT. KIMIA FARMA JAKARTA TOPGESIC 26-08-2019
121 PT. GLOBAL MULTI PHARMALAB CERVAS 400 03-02-2019 122 PT. GLOBAL MULTI PHARMALAB CERVAS 800 03-02-2019 123 PT. GLOBAL MULTI PHARMALAB COREDRYL EXPECTORANT 24-02-2019
124 PT. Bernofarm DOMPERIDON 24-01-2019
125 PT. Bernofarm NOMESIS 22-09-2019
126 PT. Natura Laboratoria Prima DOMPERIDON 22-09-2019
127 PT. Infion DOMPERIDON 22-09-2019
128 PT. Infion VOMIPER 22-09-2019
129 PT. MERSIFARMA TM LODOMER DROPS 20-05-2019
130 PT.Erela chloramphenicol 18-03-2020
131 Dexa Medica ECLID 50 31-12-2019
132 Dexa Medica ECLID 100 31-12-2019
133 PT SANBE FARMA OCUFLAM 0,1% 03-02-2019
134 PT. Novell Pharmaceutical Laboratories COOLING 5 (COOLMINT) 27 februari 2019 135 PT. Pabrik Pharmasi Zenith Coldrexin Pilek 27-06-2019 136 PT. Pabrik Pharmasi Zenith Inadoxin Forte 03-09-2019
137 PT. L'Essential Estera 0,1% 20-03-2019
138 PT. L'Essential Estera 0,05% 20-03-2019
139 PT. L'Essential Estera 0,025% 20-03-2019