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) Cefoperazone Sodium Cefepime Hydrochloride PT. INTERBAT INTERMOXIL 125 PT. INTERBAT INTERMOXIL FORTE 250 Piracetam 400 Piracetam 800 PT. Ferron Par Pharmaceuticals Fepiram 800 PT.Erela PT.Erela erlamycetin chloramphenicol PT. Guardian Pharmatama CUPANOL Otto Pharmaceutical Industries VERDIF Otto Pharmaceutical Industries NICARDIPINE HYDROCHLORIDE PT. Fresenius Kabi Combiphar Nephrosteril PT. Mulia Farma Suci Cefadroxil 250 PT. Mulia Farma Suci PT. Marin Liza Farmasi Ketoconazole Folic Acid 7 Selasa, 11 Desember 2018 PT Sanbe Farma CORTIDEX 8 Selasa, 11 Desember 2018 PT. PHAROS INDOESIA OZEN 9 Selasa, 11 Desember 2018 PT. ETHICA Industri Farmasi Ondansetron HCl Dihydrate 10 Selasa, 11 Desember 2018 PT. Pharos Indonesia KOLTON 300 REGISTRASI VARIASI OG (RESUBMIT) PIM Pharmaceuticals Analpim PT. SAMCO FARMA DOMESTRIUM PT. Nulab Pharmaceutical Indonesia Triamcinolone 4 mg (Dus, 5 strip @ 10) PT. Nulab Pharmaceutical Triamcinolone 4 mg (Dus, 10 strip @ Indonesia 10) PT. Nulab Pharmaceutical Indonesia Rebamipide 100 mg 7 Selasa, 11 Desember 2018 8 Selasa, 11 Desember 2018 9 Selasa, 11 Desember 2018 10 Selasa, 11 Desember 2018
RENEWAL OG Tanggal Berakhir NIE PT BERNOFARM THIOPENTAL SODIUM 0,5 g 03-12-2018 PT BERNOFARM TIOPOL 03-12-2018 PT BERNOFARM THIOPENTAL SODIUM 1 g 03-12-2018 PT Bernofarm FLUDIS 28-11-2018 PT Novell Pharmaceutical Lab Bisoprolol Fumarate 27-12-18 PT. Bernofarm TARONTAL 28 November 2018 PT Bernofarm TARONTAL 20-12-2018 PT. BERNOFARM KETOPROFEN 28-11-18 PT. INFION FIOCILAS 17-01-2019 PT. INFION FIORAMOL 10-01-2019 Tanggal Berakhir NIE PT. PHAROS INDONESIA AZTRIN 28 NOPEMBER 2018 PT Pharos Indonesia Fixiphar 28 Nov 2018 PT Otto Pharmaceutical Industries FLUZEP 31 Januari 2019 PT. Sanbe Farma NEUKINE 27 Februari 2019 SANBE FARMA MIOKAR 27-12-2018 PT. SANBE FARMA TRADOSIK 16-12-18 7 Selasa, 11 Desember 2018 PT CENDO CENDO MYCOS 27-12-2018 8 Selasa, 11 Desember 2018 PT CENDO CENDRID (MD) 22-11-2018 9 Selasa, 11 Desember 2018 PT CENDO CENDRID (5 ml) 22-11-2018 10 Selasa, 11 Desember 2018 PT CENDO CENDRID (15 ml) 22-11-2018 Tanggal Berakhir NIE 1 Rabu, 12 Desember 2018 PT. SOLAS LANGGENG SEJAHTERA FIXAM 31-10-2018 2 Rabu, 12 Desember 2018 PT Combiphar Cardiocom 300 27-02-2019 3 Rabu, 12 Desember 2018 PT. Soho Industri Pharmasi SOHOBION 5000 03-01-2019 4 Rabu, 12 Desember 2018 PHAPROS Rifampicin 75/INH50 16 Februari 2019 5 Rabu, 12 Desember 2018 6 Rabu, 12 Desember 2018 7 Rabu, 12 Desember 2018 8 Rabu, 12 Desember 2018 9 Rabu, 12 Desember 2018 10 Rabu, 12 Desember 2018 PT. Pharos Indonesia POLYSILANE MAX 31-01-2019 PT. Pharma CEFIXIME 07-02-2019 PT. Pharma PHARMAFIX 04-02-2019 PT. GLOBAL MULTI PHARMALAB EXITROL 08-01-2019 PT. Soho Industri Pharmasi Sohobion 5000 03-01-2019 farmasi laurel lauramox forte 3 februari 2019 Tanggal Berakhir NIE 1 Kamis, 13 Desember 2018 SIMEX PHARMACEUTICAL SIMTIN (RESUBMIT) 04-02-2019 2 Kamis, 13 Desember 2018 PT. Hexpharm Jaya Tamezole 20 03 Feb 2019 3 Kamis, 13 Desember 2018 PT. Kalbe Farma, Tbk Brexel 0,5 ml 2 Februari 2019 4 Kamis, 13 Desember 2018 PT. Kalbe Farma, Tbk Brexel 2 ml 2 Februari 2019 5 Kamis, 13 Desember 2018 6 Kamis, 13 Desember 2018 7 Kamis, 13 Desember 2018 8 Kamis, 13 Desember 2018 9 Kamis, 13 Desember 2018 10 Kamis, 13 Desember 2018 PT. PRATAPA NIRMALA Farmalat 31-01-2019 PT. Mersifarma TM Simvastatin 27-01-2019 PT. Mersifarma TM Haloperidol 5 03-01-2019 PT. Etercon Pharma AZTERCON 18 Februari 2019 PT. Berlico Mulia Farma LICOPRIMA 27-01-2019 PT Medifarma GASTRAN 31-01-2019
CADANGAN RESUBMIT VARIASI OG No. PENDAFTAR NAMA OBAT 1 2 CADANGAN REGISTRASI VARIASI OG No. PENDAFTAR NAMA OBAT 1 PT. INTERBAT ACITRAL 2 PT. INTERBAT Sitro 300 3 PT. Mulia Farma Suci Gencef 250 4 PT. Mulia Farma Suci Nizogen 5 PT. DEXA MEDICA DIVITI 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 PT Lapi PT MEPROFARM TOFEDEX Injeksi PIRACETAM DEXPIRA ANTASIDA DOEN NORAGES Dexpira 800 Ginifar PT. Pratapa Nirmala PT. Kimia Farma Bandung PT. Pharos Indonesia Cryptal TABLET TAMBAH DARAH NEO POLYSILANE TABLET PI PT. Pratapa Nirmala FARMABES 5 Chlorphenamine maleat PT. Pharos Indonesia KOLTON 300 PT. Pharos Indonesia PT Pharos Indonesia PT Pharos Indonesia PT. Bintang Toedjoe PT DARYA-VARIA LABORATORIA POLYSILANE TAB KUNYAH Esomeprazole Sodium Nexigas Rozgra CHLORPHENAMINE MALEAT AMOXICILLIN TRIHYDRATE Rozgra Komix Rasa Jahe EPIFRI
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 3-Mar-17 daftar ke OG 4 PT. Pabrik Pharmasi Zenith Coldrexin Expectorant dan Pilek 22-Apr-18 daftar ke OG 5 PT Etercon Pharma DOBUTAMIN HCl 18 MARET 2019 6 PT. Triyasa Nagamas Farma Obatine 7 PT. Phapros, Tbk Phaminov 06-10-2019 8 PT. BERNOFARM REMATOF 21-09-2019 9 PT Dipa Pharmalab Intersains GEMEDAC 200 mg 7 Mei 2019 10 PT Dipa Pharmalab Intersains GEMEDAC 1000 mg 7 Mei 2019 11 PT Meprofarm ARSINAL 12 Amlodipine besilate 22-10-2019 13 Zevask 10 22-10-2019 14 PT MEPROFARM SIZORIL 25 19-07-2019 15 PT. Kalbe Farma, Tbk. Rantin 10-05-2019 20-03-2019 04-08-2019 16 PT. Galenium Pharmasia Neladryl Expectorant 31-01-2018 daftr ke OG 17 Laboratiries PT. Kalbe Farma, Tbk. Pospargin 27-06-2019 18 PT Indofarma Tbk Aciclovir 400 4 Agustus 2019 19 PT Indofarma Tbk Aciclovir 200 4 Agustus 2019 20 PT. L'Essential ESTERA 20-03-2019 21 PT Otsuka Indonesia OTSU-D5, NS 02-10-2019 22 PT. Kalbe Farma, Tbk Aminofusin L-600 11 May 2019 23 PT. Gracia Pharmindo TOPRAS 27 April 2019 24 PT Tunggal Idaman Abdi MAGNIDICON - 25 PT Lapi CEFXON 23 September 2019 26 PT. Ferron Par Pharmaceuticals AFUCID 25-06-2019 27 PT HARSEN Fenida 27 Juni 2019 28 PT. Bernofarm METRONIDAZOLE 18-09-2019 29 NOPRENIA 1 mg 20 FEBRUARI 2019 30 NOPRENIA 2 mg 06 APRIL 2019 31 NOPRENIA 3 mg 06 APRIL 2019 32 PT. Pabrik Pharmasi Zenith Inadoxin Forte 03-09-2019 33 PT. Dankos Farma, Jakarta SPIROLA 25 31-03-2019 34 PT. Dankos Farma, Jakarta SPIROLA 100 31-03-2019 PT NOVELL RYVEL 14 APRIL 2019 35 PHARMACEUTICAL LABORATORIES 36 PT.PHAROS INDONESIA ACLONAC 50 2 SEPTEMBER 2019 37 PT Dexa Medica PROBENID 12-12-2019 38 Erlimpex colinpha 27-06-2019 39 PT. Finusolprima Farma Internasional KALBAMIN 1 Juli 2019 40 PT. Finusolprima Farma Internasional RENXAMIN 1 Juli 2019 41 Erela prednison 21-09-2019 42 PT. Kalbe farma Promag 43 PT. TRIMAN PREDNISONE 17-112019 44 PT. TRIMAN CHLORPHENIRAMINE 4 mg 17-11-2019 45 PT. L'Essential Estera 0,1% 20-03-2019 46 PT. L'Essential Estera 0,05% 20-03-2019 47 PT. L'Essential Estera 0,025% 20-03-2019 48 PT.Indofarma captopril 25 (resubmit) 29-05-209 49 PT. BERNOFARM FENAREN 07-09-2019 50 PT. Bernofarm PHENOBIOTIC 08-06-2019 51 Taisho Pharmaceutical Indonesia Ambroxol HCl drops 16-05-2019 52 53 Taisho Pharmaceutical Indonesia Ambroxol HCl sirup 15 16-05-2019 Taisho Pharmaceutical Indonesia Ambroxol HCl sirup 30 16-05-2019 54 PT. BERNOFARM Allopurinol 09-07-19 55 PT. Kimia Farma, Bandung ALLOPURINOL 20-12-2019 56 PT Lapi CRAVOX 500 27-06-2019 57 PT. DANKOS FARMA Neciblok 15-06-2019 58 PT Lapi Movix-7.5 22 November 2019 59 PT Lapi Movix 15 22 November 2019 60 PT. SAMPHARINDO PERDANA SIOBION 7 AGUSTUS 2019 61 Erlimpex kapedoxin (strip) 31-05-2019 62 Erlimpex kapedoxin (botol) 31-05-2019 63 Dexa Medica GLUVAS 3 20-10-2019 64 PT Ferron Par Pharmaceuticals TRIXIM 200 27 Juni 2019 65 Dexa Medica GLUVAS 4 20-10-2019 66 PT. Kalbe Farma, Tbk Vincristine Kalbe 1 ml 30 Jun 2019 67 PT. Kalbe Farma, Bekasi Vincristine Kalbe 2 ml 30 Jun 2019 68 PT. COMBIPHAR MALTOFER 7 September 2019 69 PT. PHAROS INDONESIA CHOLESPAR 10 31 DESEMBER 2017 daftr ke OG 70 PT. PHAROS INDONESIA CHOLESPAR 20 31 DESEMBER 2017 daftr ke OG 71 PT. INTERBAT Amlodipine Besylate 5 10 Februari 2019
72 PT. INTERBAT Amlodipine Besylate 10 10 Februari 2019 73 PT. Kimia Farma, Bandung MIKRODIOL 30 (catch cover) 04-08-2019 74 PT. Kimia Farma, Bandung MIKRODIOL 30 (100 blister) 04-08-2019 75 PT. Kimia Farma, Bandung Pil KB I Kombinasi 27-11-2019 76 PT Meprofarm SUPRAFENID 04-08-2019 77 PT Meprofarm SUPRAMOX 11-08-2019 78 PT Meprofarm ARSINAL 04-08-2019 79 Erlimpex stanalin ds 08-06-2019 80 PT. Ferron Par Pharmaceuticals HISTRINE 13-04-2019 81 PT. Kalbe Farma, Tbk Paxus 30 12 Aug 2019 82 EXPECTORANT 30 ml 83 EXPECTORANT 60 ml 84 EXPECTORANT 100 ml 85 SILADEX COUGH & COLD 30 ml 06-04-2019 86 SILADEX COUGH & COLD 60 ml 06-04-2019 87 PT. DEXA MEDICA CETIRIZINE HCL 15-10-2019 88 Erlimpex momet 11-12-2019 89 Erlimpex neo kaocitin 11-12-2019 90 Erlimpex erphapain 02-12-2019 91 PT. Bernofarm ANAFEN 27-06-2019 92 PT. DEXA MEDICA DEXA - M 05-09-2019 93 PT Novell Pharmaceutical Lab Omeprazole 03-03-2019 94 ANTASIDA DOEN 13-05-2019 95 PT. Pratapa Nirmala FARPAIN 30 02-12-2019 96 PT. SOLAS LANGGENG SEJAHTERA Nootrisol 27-06-2019 97 Orsaderm 21/07/2019 98 Kanina 31/04/2019 99 PT NUFARINDO NUFADEX M 08-06-2019 100 PT. Pratapa Nirmala FARPAIN 30 02-12-2019 101 PT. Ferron Par Pharmaceuticals AFUCID 25-06-2019 102 ANTASIDA DOEN 13-05-2019 103 PT Yarindo Farmatama Isosorbide Dinitrate 12-12-2019 104 PT. BERNOFARM FENAREN 07-09-2019 105 PT. Kalbe farma Promag 106 Dexa Medica Cefazolin Sodium 27 Mei 2019 107 ANTASIDA DOEN 13-05-2019 108 PT. Bernofarm ANAFEN 27-06-2019 109 PT Lapi LAPICEF 125 06 OKTOBER 2019 110 PT Lapi LAPICEF 250 06 OKTOBER 2019 111 PT. Ferron Par Pharmaceuticals CINOGENTA 08-06-2019 112 PT BERNOFARM BERSOL (tube @ 5) 04-09-2019 113 PT BERNOFARM BERSOL (tube @ 15) 04-09-2019 114 PT BERNOFARM METHYLPREDNISOLONE 22-09-2019 115 GLUVAS 1 20 Oktober 2019 116 GLUVAS 2 20 Oktober 2019