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) No. Tanggal Pelayanan Pendaftar Produk 1 Senin, 22 Oktober 2018 PT. Graha Farma BRONKRIS 2 Senin, 22 Oktober 2018 PT. Graha Farma GRAFADON 3 Senin, 22 Oktober 2018 PT. Kimia Farma Jakarta Dopamin Giulini 4 Senin, 22 Oktober 2018 PT. Kimia Farma, Bandung Diethylcarbamazine Citrate 5 Senin, 22 Oktober 2018 6 Senin, 22 Oktober 2018 PT. Sterling Products Indonesia, Jakarta PT. Sterling Products Indonesia, Jakarta Triaminic Pilek Rasa Jeruk Triaminic Ekspektoran + Pilek (Rasa Lemon) 7 Senin, 22 Oktober 2018 PT. Sterling Products Indonesia Panadol Anak-Anak Tablet Kunyah 8 Senin, 22 Oktober 2018 PT Etercon Pharma OMEPRAZOLE SODIUM 9 Senin, 22 Oktober 2018 PT. Ethica Industri Farmasi Aminoral 10 Senin, 22 Oktober 2018 PT. Dion Farma Abadi, Klaten Calmdion No. Tanggal Pelayanan Pendaftar Produk 1 Selasa, 23 Oktober 2018 PT. Dexa Medica Dexpira 20% 2 Selasa, 23 Oktober 2018 PT Dexa Medica PRONALGES 100 3 Selasa, 23 Oktober 2018 Ferron Par Pharmaceuticals Fepiram 4 Selasa, 23 Oktober 2018 Ferron Par Pharmaceuticals Nicafer 5 Selasa, 23 Oktober 2018 PT. Kalbe Farma, Tbk Cholestat 20 6 Selasa, 23 Oktober 2018 PT. Kalbe Farma, Tbk Mefentan 7 Selasa, 23 Oktober 2018 PT. Futamed Pharmaceuticals Desfumed 8 Selasa, 23 Oktober 2018 PT. Dankos Farma, Jakarta NEUROTAM 200 Injeksi 9 Selasa, 23 Oktober 2018 PT. Lucas Djaja vitamin A 100.000 IU Kapsul Lunak 10 Selasa, 23 Oktober 2018 PT. Lucas Djaja vitamin A 200.000 IU Kapsul Lunak
REGISTRASI VARIASI OG (RESUBMIT) No. Tanggal Pelayanan Pendaftar Produk 1 Senin, 22 Oktober 2018 PT. Actavis Indonesia Episindan 2 Senin, 22 Oktober 2018 3 Senin, 22 Oktober 2018 4 Senin, 22 Oktober 2018 5 Senin, 22 Oktober 2018 6 Senin, 22 Oktober 2018 7 Senin, 22 Oktober 2018 8 Senin, 22 Oktober 2018 9 Senin, 22 Oktober 2018 10 Senin, 22 Oktober 2018 No. Tanggal Pelayanan Pendaftar Produk 1 Selasa, 23 Oktober 2018 PT. Hexpharm Jaya KETOROLAC INJEKSI 30 2 Selasa, 23 Oktober 2018 3 Selasa, 23 Oktober 2018 4 Selasa, 23 Oktober 2018 5 Selasa, 23 Oktober 2018 6 Selasa, 23 Oktober 2018 7 Selasa, 23 Oktober 2018 8 Selasa, 23 Oktober 2018 9 Selasa, 23 Oktober 2018 10 Selasa, 23 Oktober 2018
RENEWAL OG No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir NIE 1 Senin, 22 Oktober 2018 PT Bernofarm METFORMIN HCl 28-Nov-18 2 Senin, 22 Oktober 2018 PT Bernofarm METFORMIN HCl 28-Nov-18 3 Senin, 22 Oktober 2018 PT RAMA EMERALD MULTI SUKSES Diapecta 23-Dec-18 4 Senin, 22 Oktober 2018 PT. INTERBAT PAMOL 10-Mar-19 5 Senin, 22 Oktober 2018 PT HARSEN Fusaltrax 23-Dec-18 6 Senin, 22 Oktober 2018 PT. MERSIFARMA TM MAPROTILINE HCl 23-Dec-18 7 Senin, 22 Oktober 2018 PT. SAMCO FARMA SAMMOXIN 23-Dec-18 8 Senin, 22 Oktober 2018 PT. SAMCO FARMA samconal 15-Apr-19 9 Senin, 22 Oktober 2018 PT. SAMCO FARMA SAMCOVASK 5 Kaplet 30-Apr-19 10 Senin, 22 Oktober 2018 PT. SAMCO FARMA SAMCOVASK 10 Kaplet 30-Apr-19 No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir NIE 1 Selasa, 23 Oktober 2018 PT CENDO NONCORT 28-Nov-18 2 Selasa, 23 Oktober 2018 PT. Berlico Mulia Farma LICOPRIMA FORTE 27-Dec-18 3 Selasa, 23 Oktober 2018 PT Sanbe Farma INFUSAN RL (DPWO) 500 ml Infus 6-Sep-18 4 Selasa, 23 Oktober 2018 PT Sanbe Farma INFUSAN RL (SPTO) 500 ml Infus 6-Sep-18 5 Selasa, 23 Oktober 2018 PT Sanbe Farma ANBACIM 23-Dec-18 6 Selasa, 23 Oktober 2018 PT. Sanbe Farma NOLIPO 23-Dec-18 7 Selasa, 23 Oktober 2018 PT. Sanbe Farma SANOTREXAT Injeksi 30-Jan-19 8 Selasa, 23 Oktober 2018 PT. Sanbe Farma METHOTREXATE Injeksi 30-Jan-19 9 Selasa, 23 Oktober 2018 PT. MAHAKAM BETA FARMA Ondansetron HCl 18-Mar-19 10 Selasa, 23 Oktober 2018 PT. MAHAKAM BETA FARMA Ondansetron HCl 18-Mar-19 No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir NIE 1 Rabu, 24 Oktober 2018 PT. Pabrik Pharmasi Zenith ZELONA 3-Jan-19 2 Rabu, 24 Oktober 2018 PT. Kimia Farma Jakarta Fluconazole 25-Apr-19 3 Rabu, 24 Oktober 2018 PT Medifarma Laboratories GASTRAN 31-Jan-19 4 Rabu, 24 Oktober 2018 PT. SIMEX PHARMACEUTICAL SIMTOR 10 Kaplet ss 4-Mar-19 5 Rabu, 24 Oktober 2018 PT. SIMEX PHARMACEUTICAL SIMTOR 20 Kaplet ss 4-Mar-19 6 Rabu, 24 Oktober 2018 PT. Combiphar OBH COMBI Anak Batuk Plus Flu Rasa Apel 13-Apr-19 7 Rabu, 24 Oktober 2018 PT Combiphar Comdipin 10 6-Apr-19 8 Rabu, 24 Oktober 2018 GRACIA PHARMINDO VOMISTOP 3-Mar-19 9 Rabu, 24 Oktober 2018 PT. Gracia Pharmindo MESOL 8 29-Jan-19 10 Rabu, 24 Oktober 2018 GRACIA PHARMINDO VOMISTOP 27-Jan-19
No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir NIE 1 Kamis, 25 Oktober 2018 PT MEPROFARM CRIAX 25-Mar-19 2 Kamis, 25 Oktober 2018 PT. Dexa Medica VOLTADEX 28-Apr-19 3 Kamis, 25 Oktober 2018 PT. Ferron Par Pharmaceuticals FRAZON Kaplet ss 15-Apr-19 4 Kamis, 25 Oktober 2018 PT. Ferron Par Pharmaceuticals FORDERM Krim 15-Apr-19 5 Kamis, 25 Oktober 2018 PT. Dankos Farma, Jakarta TRANSMUCO 31-Mar-19 6 Kamis, 25 Oktober 2018 PT. Dankos Farma Minigrip-P 23-Jan-19 7 Kamis, 25 Oktober 2018 PT. Dankos Farma SALBRON 4 14-Apr-19 8 Kamis, 25 Oktober 2018 PT. Kalbe Farma, Tbk Kalxetin 15-Apr-19 9 Kamis, 25 Oktober 2018 PT. Kalbe Farma, Tbk Kaltrofen 100 mg (suppositoria) 15-Apr-19 10 Kamis, 25 Oktober 2018 PT. Pabrik Pharmasi dan Kimia Dasa Esa Farma Paracetamol 24-Apr-19
CADANGAN REGISTRASI VARIASI OG No. PENDAFTAR NAMA OBAT 1 PT. Graha Farma HISTAKLOR 2 PT. Graha Farma FLUNAX 3 PT. Erlimpex Stanalin ds 4 PT. Sterling Products Indonesia Panadol Anak-Anak Syrup 5 PT. Sterling Products Indonesia Panadol Anak-Anak Suspensi 6 PT. Sterling Products Indonesia Panadol Anak-Anak Drops 7 PT. Combiphar OBH COMBI Batuk Plus Flu Rasa Madu Sirup (btl pls 60 ml) 8 PT. Combiphar OBH COMBI Batuk Plus Flu Rasa Madu Sirup (btl pls 100 ml) 9 PT. Genero Pharmaceuticals ESINOL Gel (tube 10 g) 10 PT. Genero Pharmaceuticals ESINOL Gel (tube 90 g) 11 7/ OTSU-RL Infus (btl pls 500 ml) 12 PT MEPROFARM SOLVINEX Kaplet 13 PT. Hexpharm Jaya Ranitidine HCl Injeksi 14 PT. Sanbe Farma EPISAN Suspensi (btl 100 ml) 15 PT. Sanbe Farma EPISAN Suspensi (btl 200 ml) 16 PT MEPROFARM DIAZEPAM Injeksi 17 PT. MOLEX AYUS LEXAPROFEN 400 Kaplet ss 18 PT Meprofarm Sucralfate Suspensi (btl 100 ml) 19 PT Meprofarm MUCIFAT Suspensi 20 PT. Erela Erlaflu Sirup 21 PT Lapi Laboratories LAGESIL 22 PT. Rama Emerald Multi Sukses ALLOPURINOL 23 PT. Rama Emerald Multi Sukses SOLARIC 24 PT KONIMEX KONIMAG 25 PT IFARS Pharmaceutical Laboratories Roverton 26 PT. Kimia Farma, Bandung Caotopril 27 ORVAST 40 28 ORVAST 20 29 ORVAST 10 30 ATORVASTATIN CALCIUM TRIHYDRATE 31 ATORVASTATIN CALCIUM TRIHYDRATE 32 PT Tunggal Idaman Abdi Thrombophob 33 PT Tunggal Idaman Abdi Thrombophob 34 Erlimpex ersolon 35 PT Meprofarm Ranitidine HCl
CADANGAN REGISTRASI ULANG No. Pendaftar Produk Tanggal Berakhir NIE 1 PT. Indofarma Tbk Piroxicam 10-Nov-19 2 Dexa Medica DEXAFLOX 23-Jun-19 3 Otto Pharmaceutical DIAFORMIN XR 4-Aug-19 4 Otto Pharmaceutical METFORMIN HCL 500 mg XR 4-Aug-19 5 PT. Kalbe Farma, Tbk Kalmethasone 31-Aug-19 6 PT. Sunthi Sepuri Ativan 29-Sep-19 7 PT. PERTIWI AGUNG REGIT 6-Nov-19 8 PT. Phapros, Tbk Phaminov 6-Oct-19 9 PT OTSUKA INDONESIA Obucort Swinghaler 28-Apr-19 Ke SubDit Obat Baru 10 PT OTSUKA INDONESIA Meptin Swinghaler 28-Apr-19 Ke SubDit Obat Baru 11 PT Yarindo Farmatama Ibuprofen 400 13-Sep-19 12 PT. PHAROS INDONESIA POLYSILANE 180 ML 29-Jul-19 13 PT. MERSIFARMA TM TRIFLUOPERAZINE 2HCl 5-Aug-19 14 PT Combiphar Cardiocom 150 27-Feb-19 15 PT. Finusolprima Farma Internasional FASGO 12-Jun-19 16 PT Lapi Laboratories RHELAFEN FORTE 22-Jul-19 17 PT Lapi Laboratories RHELAFEN SUSPENSI 22-Jul-19 18 PT. Tempo Scan Pacific Tbk BODREXIN PILEK ALERGI 15-Oct-19 19 PT Nufarindo Lansoprazole 7-Jul-19 20 PT Nufarindo Nufadex M 0.75 mg 8-Jun-19 21 PT Nufarindo Nufadex M 0.5 mg 8-Jun-19 22 PT. Dexa Medica Vometa 11-May-19 23 PT. PERTIWI AGUNG Wiatrim 27-Jun-19 24 PT. Pabrik Pharmasi Zenith PULAREX 25-Aug-19 25 PT. Kalbe farma Promag 22-Jul-19 26 PT. Menarini Indria laboratories Muzoral tablet 24-Sep-19 27 PT. Menarini Indria Laboratories Muzoral krim 24-Sep-19 28 PT. Kimia Farma, Bandung Nifedipine 5-May-19 29 PT. Harsen Reprosid 24-Aug-19 30 PT Lapi Laboratories RHELAFEN FORTE 22-Jul-19 31 PT Lapi Laboratories RHELAFEN SUSPENSI 22-Jul-19 32 PT. MOLEX AYUS MOLASIC 4-Aug-19 33 PT. MOLEX AYUS MOLACORT 0,75 4-Aug-19 34 PT Combiphar Tyason 7-May-19 35 PT CATUR DAKWAH CRANE FASUSUK KB II TIGA TAHUNAN 31-Aug-19 36 PT CATUR DAKWAH CRANE FASinoplant 31-Aug-19 37 PT. Pabrik Pharmasi Zenith FLAZEN 3-Feb-19 38 PT. KIMIA FARMA, JAKARTA DOXYCYCLINE HYCLATE 3-May-19 39 PT. Guardian Pharmatama FUNGASOL 26-May-19 40 PT. NICHOLAS LABORATORIES INDONESIA NICHOFED SYRUP 27-Jun-19 41 PT. Sunthi Sepuri Ativan 1 29-Sep-19 42 PT. Sunthi Sepuri Ativan 2 29-Sep-19 43 PT. Sunthi Sepuri Gunaceta 11-Sep-19 44 PT Ferron Par Pharmaceuticals Dilavask 27-Jun-19 45 PT Dipa Pharmalab Intersains FEXOVEN OD 28-Oct-19 46 PT. DANKOS FARMA Mikasin 10-May-19 47 PT. Erela erlaflu 2-May-19 48 PT. Erlimpex stanalin ds 8-Jun-19 49 PT. SANBE FARMA Irinotecan Hydrochloride 2 ml (Resubmit) 26-Aug-18 50 PT. SANBE FARMA Irinotecan Hydrochloride 5 ml (Resubmit) 26-Aug-18 51 PT. SANBE FARMA Romisan 2 ml (Resubmit) 26-Aug-18 52 PT. SANBE FARMA Romisan 5 ml (Resubmit) 26-Aug-18 53 PT. Dexa Medica Lisinopril 5 Tab 20-Oct-19 54 PT. Dexa Medica Lisinopril 10 Tab 20-Oct-19 55 PT. Pabrik Pharmasi Zenith Zephanal 50 Kapsul 26-Jun-19 56 PT. HOLI PHARMA RANITIDINE 300 Kaplet 27-Jun-19 57 PT. DEXA MEDICA ANTASIDA DOEN Suspensi 27-Jun-19 58 PT NOVELL KETOROLAC TROMETAMOL 10 PHARMACEUTICAL LAB Tab ss 27-Jun-19 59 PT. Kalbe Farma, Tbk Kalmethasone Tab 31-Aug-19 60 PT. Kalbe Farma, Tbk Neuralgin Rx Kaplet ss 19-May-19 61 PT. Kalbe Farma, Tbk Aminofusin L 600 Infus 11-May-19 62 PT Nufarindo Lansoprazole 30 Kapsul 7-Jul-19 63 PT Nufarindo Nufadex M 0,75 Kaplet 8-Jun-19 64 PT Nufarindo Nufadex M 0,5 Kaplet 8-Jun-19
65 PT Yarindo Farmatama RELOX 15 Tab 2-May-19 66 PT. Hexpharm Jaya Ondansetron HCl 8 mg Injeksi 27-Jun-19 67 PT. Hexpharm Jaya Ondansetron HCl 4 mg Injeksi 27-Jun-19 68 PT. First Medipharma Chloramphenicol suspensi (TD Renewal) Suspensi Tidak ada informasi masa berlaku 69 PT. First Medipharma Medichlor suspensi (TD renewal) Suspensi Tidak ada informasi masa berlaku 70 PT Harsen FUSALTRAX DS 13-Jul-19 71 PT HARSEN DECATRIM Kaplet 13-Jul-19 72 PT MEPROFARM LOREMID Tab ss 25-Jul-19 73 PT MEPROFARM SIZORIL - 25 Tab 19-Jul-19 74 PT Yarindo Farmatama Rinclo Tab ss 1-Jul-19 75 PT. DEXA MEDICA DILTIAZEM HCL 30 Tab 30-Jun-19 76 PT CENDO CONAL (MD) Tetes mata 23-Nov-18 77 PT CENDO CONAL (5 ml) Tetes mata 23-Nov-18 78 PT. Dexa Medica Nicardipine HCL Injeksi 27-Jun-19 79 PT. Dexa Medica Nicardex Injeksi 27-Jun-19 80 PT Dipa Pharmalab Intersains Gemedac Serb Infus (vial 200 mg) 7-May-19 81 PT Dipa Pharmalab Intersains Gemedac Serb Infus (vial 1000 mg) 7-May-19 82 PT. SAMPHARINDO PERDANA SIOBION Kapsul 7-Aug-19 83 PT Indonfarma Ibuprofen 100 Suspensi 16-Dec-19 84 PT Indofarma Tbk Ibuprofen 200 Suspensi 16-Dec-19 85 PT Indofarma Tbk Furosemide Tab 5-Aug-19 86 PT. NICHOLAS LABORATORIES INDONESIA NEO MERCAZOLE Tab 27-Jun-19 87 PT. NICHOLAS LABORATORIES INDONESIA NILATIKA Tab 27-Jun-19 88 PT. NICHOLAS LABORATORIES INDONESIA BRONCHOLIT Sirup 27-Jun-19 89 ERRITA PHARMA ETADEX 4-Aug-19 90 PT. Gracia Pharmindo PROMUXOL 27-Feb-19 91 GRACIA PHARMINDO VOMISTOP 3-Mar-17 92 PT. Graha Farma GRASOLON 8 1-Jul-19 93 PT. Pabrik Pharmasi Zenith FLAZEN 3-Feb-19 94 PT IFARS Pharmaceutical Laboratories Glikos 850 3-Feb-19 95 PT. Caprifarmindo DENUFAM 20 (Resubmit) 9-Sep-18 96 PT Ferron Par Pharmaceuticals NICAFER 27-Jun-19 97 PT Ferron Par Pharmaceuticals EVALEN 27-Jun-19 98 PT.Indofarma gemfibrozil 300 (TD) 11-Sep-18 99 PT.Indofarma captopril 12,5 mg 29-May-19 100 PT. Indofarma Captopril 25 mg (TD) 29-May-19 101 PT.Indofarma AMITRIPTYLINE HCL (TD) 31-Mar-19 102 PT. Bufa Aneka BUfacomb 13-Oct-19 103 PT. Pabrik Pharmasi Zenith Coldrexin Expectorant dan Pilek 22-Apr-18 104 PT. Promedrahardjo FI Prolecin 27-Jun-19 105 PT IFARS Pharmaceutical Laboratories Tidifar 200 21-Jul-19 106 Erlimpex colinpha 27-Jun-19 107 PT Combiphar Profecom 4-Aug-19 108 PT Lapi Laboratories LACOLDIN 22-Jul-19 109 PT IFARS Pharmaceutical Laboratories Fasiprim 11-May-19 110 PT. First Medipharma Yasiden 10 (TD Renewal) 11-Jan-18 111 PT. First Medipharma Yasiden 20 (TD Renewal) 11-Jan-18 112 PT. First Medipharma Piroxicam 10 mg (TD Renewal) 15-Jan-18 113 PT. First Medipharma Piroxicam 20 mg (TD Renewal) 23-Jan-18 114 PT Indofarma Tbk Clonidine Hidrochloride 27-Apr-19 115 PT Indofarma Tbk Doxycicline Hyclate 4-Jul-19 116 PT Dexa Medica PIRACETAM INJEKSI 5 ML 30-Jun-19 117 PT. Dankos Farma, Jakarta DIGEST 17-Nov-19 118 PT. Hexpharm Jaya Omeprazole 3-Feb-19 119 PT. Hexpharm Jaya Tamezole 20 3-Feb-19 120 PT. Dexa Medica TEOSAL 14-Sep-19 121 PT. Dexa Medica CLINDAMYCIN 1-Dec-19 122 PT MEPROFARM ARSINAL 4-Aug-19 123 PT Bernofarm BENOFOMIN 28-Nov-19
124 PT Bernofarm BENOFOMIN 28-Apr-19 125 PT Bernofarm BENOFOMIN 28-Apr-19 126 PT. MAHAKAM BETA FARMA Valos 500 20-Jun-21 127 PT. Mutiara Mukti Farma (MUTIFA) OMENIZOL 17-Feb-19