REGISTRASI VARIASI OC
No. Tanggal Pelayanan Pendaftar Produk Estimasi Jam
Pelayanan
1 Senin, 29 Mei 2017 TROPICA MAS
PHARMACEUTICALS
OBH TROPICA
EXPECTORANT ANAK RASA MADU (Botol @ 60 ml Botol @ 100 ml)
08.30
2 Senin, 29 Mei 2017 TROPICA MAS
PHARMACEUTICALS
NEW ANTIDES 09.00
3 Senin, 29 Mei 2017 PT. MERSIFARMA TM RIKLONA 2 09.30
4 Senin, 29 Mei 2017 PT. MERSIFARMA TM CLONAZEPAM 10.00
5 Senin, 29 Mei 2017 PT. DEXA MEDICA AZOMAX 500 Kaptab Salut Selaput
10.30 6 Senin, 29 Mei 2017 PT. DEXA MEDICA GLUMIN XR Kaptab
Pelepasan Lambat
11.00 7 Senin, 29 Mei 2017 PT BIMA MITRA FARMA BIMASTAN 500 Kaptab Salut
Selaput
12.30 8 Senin, 29 Mei 2017 PT. PROMEDRAHARDJO FI PROTECLINE Cairan Injeksi 13.00 9 Senin, 29 Mei 2017 PT. HEXPHARM JAYA CEFIXIME Kapsul 13.30 10 Senin, 29 Mei 2017 PT. GUARDIAN
PHARMATAMA
FUNGASOL 14.00
No. Tanggal Pelayanan Pendaftar Produk Estimasi Jam
Pelayanan 1 Selasa, 30 Mei 2017 PT. MERSIFARMA TM CARBAMAZEPINE 08.30 2 Selasa, 30 Mei 2017 PT. MERSIFARMA TM BAMGETOL 200 09.00 3 Selasa, 30 Mei 2017 PT. DEXA MEDICA TRANEXAMIC ACID Injeksi 09.30 4 Selasa, 30 Mei 2017 PT. Combiphar OBH Combi Batuk Berdahak 10.00 5 Selasa, 30 Mei 2017 PT. GUARDIAN
PHARMATAMA
FUNGASOL 10.30
6 Selasa, 30 Mei 2017 PT. GUARDIAN PHARMATAMA
NALETAL 50 11.00
7 Selasa, 30 Mei 2017 PT. MULIA FARMA SUCI ORARHEUMA 12.30 8 Selasa, 30 Mei 2017 PT. MULIA FARMA SUCI ORARHEUMA 13.00 9 Selasa, 30 Mei 2017 PT BERNOFARM RANITIDINE HCL 13.30
10 Selasa, 30 Mei 2017 PT Bernofarm BENOCETAM 14.00
JADWAL PELAYANAN REGISTRASI VARIASI OBAT COPY
RESUBMIT VARIASI OC
No. Tanggal Pelayanan Pendaftar Produk Estimasi Jam
Pelayanan 1 Senin, 29 Mei 2017 PT HARSEN Dinasept cairan obat luar 08.30 2 Senin, 29 Mei 2017 PT. TRIFA RAYA
LABORATORIES
Trfastan kaplet 09.00
3 Senin, 29 Mei 2017 TRIFA RAYA LABORATORIES Trifadium tablet 09.30 4 Senin, 29 Mei 2017 10.00 5 Senin, 29 Mei 2017 10.30 6 Senin, 29 Mei 2017 11.00 7 Senin, 29 Mei 2017 12.30 8 Senin, 29 Mei 2017 13.00 9 Senin, 29 Mei 2017 13.30 10 Senin, 29 Mei 2017 14.00
No. Tanggal Pelayanan Pendaftar Produk Estimasi Jam
Pelayanan 1 Selasa, 30 Mei 2017 08.30 2 Selasa, 30 Mei 2017 09.00 3 Selasa, 30 Mei 2017 09.30 4 Selasa, 30 Mei 2017 10.00 5 Selasa, 30 Mei 2017 10.30 6 Selasa, 30 Mei 2017 11.00 7 Selasa, 30 Mei 2017 12.30 8 Selasa, 30 Mei 2017 13.00 9 Selasa, 30 Mei 2017 13.30 10 Selasa, 30 Mei 2017 14.00
RENEWAL OC
No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir
NIE 1 Senin, 29 Mei 2017 PT ACTAVIS INDONESIA FORMELL 850 22-11-2016 2 Senin, 29 Mei 2017 PT ACTAVIS INDONESIA FORMELL 500 07-12-2016 3 Senin, 29 Mei 2017 PT PHAROS INDONESIA LETHIRA 17-02-2017 4 Senin, 29 Mei 2017 PT PHAROS INDONESIA LETHIRA 17-02-2017
5 Senin, 29 Mei 2017 PT. Erlimpex Neuro ATP 28-02-2017
6 Senin, 29 Mei 2017 PT. Genero Pharmaceuticals Candipar 150 31-05-2017 7 Senin, 29 Mei 2017 PT Sanbe Farma SANPICILLIN 6 Juni 2017 8 Senin, 29 Mei 2017 PT SANBE FARMA BACTIROM 11 Juni 2017 9 Senin, 29 Mei 2017 PT Soho Industri Pharmasi Azithromycin 12-06-17
10 Senin, 29 Mei 2017 PT BERNOFARM UNTHECOL 03-07-2017
No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir
NIE 1 Selasa, 30 Mei 2017 PT. Pratapa Nirmala Levobupivacaine 0.5% 17 Juli 2017 2 Selasa, 30 Mei 2017 PT. Graha Farma GRAFADON FORTE 17-07-2017 3 Selasa, 30 Mei 2017 PT ETERCON PHARMA EPERISONE HCL 02-08-2017 4 Selasa, 30 Mei 2017 PT. PERTIWI AGUNG cimetidine 03/08/2017 5 Selasa, 30 Mei 2017 PT ACTAVIS INDONESIA ACTAZOLAM 0,5 03-08-2017 6 Selasa, 30 Mei 2017 PT ACTAVIS INDONESIA ACTAZOLAM 1 03-08-2017
7 Selasa, 30 Mei 2017 PT. INTERBAT Intifen 03-08-2017
8 Selasa, 30 Mei 2017 PT. PYRIDAM FARMA Tbk TYRAN 3 AGUSTUS 2017 9 Selasa, 30 Mei 2017 PT. Solas Langgeng
Sejahtera
FLAMOXI
06-Agust-17 10 Selasa, 30 Mei 2017 PT. Imfarmind Farmasi
Industri
IFIDEX 0.5 BOTOL & STRIP
13-Agust-17
No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir
NIE 1 Rabu, 31 Mei 2017 PT. Kalbe Farma Albiotin 300 13-Agust-17 2 Rabu, 31 Mei 2017 PT. Kalbe Farma Albiotin 150 13-Agust-17 3 Rabu, 31 Mei 2017 PT PHAROS INDONESIA ECRON 4 13/08/2017 4 Rabu, 31 Mei 2017 PT PHAROS INDONESIA ECRON 10 13/08/2017 5 Rabu, 31 Mei 2017 PT PHAROS INDONESIA ECRON 13/08/2017 6 Rabu, 31 Mei 2017 PT. Hexpharm Jaya Anfuhex Cream 24-Agust-17 7 Rabu, 31 Mei 2017 PT. Hexpharm Jaya Ketoconazole 27-Agust-17
8 Rabu, 31 Mei 2017 PT. INTERBAT Internolol 02-08.2017
9 Rabu, 31 Mei 2017 PT Ikapharmindo Putramas Kurtigo tablet 27-08-2017 10 Rabu, 31 Mei 2017 PT Indofarma ZINKID tablet dispersible 30 Agustus 2017
No. Tanggal Pelayanan Pendaftar Produk Tanggal Berakhir
NIE 1 Kamis, 1 Juni 2017 Libur hari lahir pancasila Libur hari lahir pancasila
2 Kamis, 1 Juni 2017 Libur hari lahir pancasila Libur hari lahir pancasila 3 Kamis, 1 Juni 2017 Libur hari lahir pancasila Libur hari lahir pancasila 4 Kamis, 1 Juni 2017 Libur hari lahir pancasila Libur hari lahir pancasila 5 Kamis, 1 Juni 2017 Libur hari lahir pancasila Libur hari lahir pancasila 6 Kamis, 1 Juni 2017 Libur hari lahir pancasila Libur hari lahir pancasila 7 Kamis, 1 Juni 2017 Libur hari lahir pancasila Libur hari lahir pancasila 8 Kamis, 1 Juni 2017 Libur hari lahir pancasila Libur hari lahir pancasila 9 Kamis, 1 Juni 2017 Libur hari lahir pancasila Libur hari lahir pancasila 10 Kamis, 1 Juni 2017 Libur hari lahir pancasila Libur hari lahir pancasila
CADANGAN REGISTRASI VARIASI OC
No. PENDAFTAR NAMA OBAT
1 PT. GUARDIAN PHARMATAMA
NALETAL 100 2 PT. Indofarma cyanocobalamin 3 PT. Graha Farma PRO ATP 4 PT. Pratapa Nirmala,
Tangerang
CALLUSOL 5 PT. Metiska Farma ASAMNEX 6 PT. Darya-Varia Laboratoria
Tbk
ketorolac tromethamol 7 PT Combiphar Somatostatin Lyomark 8 PT Kalbe Farma Pranza
9 PT. Promedrahardjo FI AMLODIPINE 10 10 PT PRATAPA NIRMALA Bromhexine HCl 11 PT. Kalbe Farma Tbk.,
Bekasi
Sterile Water for Injection 12 PT. Kalbe Farma Tbk.,
Bekasi
Sterile Water for Injection 13 PT OTSUKA INDONESIA MEYLON-84 BP
14 PT GUARDIAN PHARMATAMA
ALMEN dan Generiknya 15 PT. Mahakam Beta Farma,
Jakarta
Betadine Feminine Hygiene 16 PT. Mahakam Beta Farma,
Jakarta
Betadine Feminine Hygiene 17 PT. Solas Langgeng
Sejahtera
SINTROL
18 PT Guardian Pharmatama KEREN dan Generiknya 19 PT Guardian Pharmatama Glamarol 1 dan Generiknya 20 PT Guardian Pharmatama Glamarol 4 dan Generiknya 21 PT. Sydna Farma Pacline
22 PT. Promedrahardjo FI AMLODIPINE 5 23 PT BIO KUSUMA Biogen
24 PT BIO KUSUMA Biogen Forte 25 PT. Hexpharm Jaya Bintamox DS
26 PT. Hexpharm Jaya Amoxicillin Trihydrate 27 PT. Hexpharm Jaya ONDANSETRON HCL 2 ML 28 PT. Hexpharm Jaya ONDANSETRON HCL 4 ML 29 PT. Triyasa Nagamas Farma Deponeo 3 ; Obat Suntik KB
1 Tiga Bulanan 30 PT. Promedrahardjo FI LORATADINE 31 PT. Solas Langgeng
Sejahtera
SINTROL
32 PT. PHAROS INDONESIA POLYSILANE KAPSUL 33 PT Yarindo Farmatama Novaldo
34 PT OTTO Pharmaceutical Industries
Pelarut Omeprazole 35 PT Dexa Medica Ramipril OGB 2,5 MG 36 PT Dexa Medica Ramipril OGB 5 MG 37 PT Dexa Medica Hyperil 2.5
38 PT Dexa Medica Hyperil 5 39 PT Ferron Par Pharmaceuticals Tenapril 2.5 40 PT Ferron Par Pharmaceuticals Tenapril 5 41 PT. Dexa Medica Spironolactone 42 PT. Ethica Industri Farmasi Epinephrine 43 PT.Ethica Industri Farmasi KETOROLAC
TROMETAMOL
44 PT.Ethica Industri Farmasi Ondansetron HCl Dihydrate 2 ML
45 PT.Ethica Industri Farmasi Ondansetron HCl Dihydrate 4 ML
47 PT.Ethica Industri Farmasi CETADOP
48 PT HARSEN MOSAVON
49 PT HARSEN GENTANAL
50 PT. Promedrahardjo FI PROPANZOL 51 PT. Kalbe Farma CLAVAMOX 52 PT. MERSIFARMA TM CLONAZEPAM 53 PT.MERSIFARMA TM INHA 400
54 PT BERNOFARM BROXAL 30 MG/5 ML 55 PT BERNOFARM BROXAL 15 MG/5 ML 56 PT. Kalbe Farma V BLOC
57 PT. Dankos Farma Mikasin 250 58 PT. Dankos Farma Mikasin 500 59 PT.MERSIFARMA TM RIKLONA 2
60 PT SANBE FARMA DIALISAN DP-4 2,5% larutan dialisis peritoneal
61 PT. Mahakam Beta Farma Betadine Vaginal Douche 62 PT.TEMPO SCAN PACIFIC DBL Dacarbazine serbuk
injeksi
63 DEXA MEDICA CEFRATAM serbuk injeksi 64 Dexa Medica CEFOPERAZONE
SULBACTAM serbuk injeksi 65 PT. Mahakam Beta Farma Ondansetron HCl injeksi 66 PT. Pratapa Nirmala SOJOURN cairan inhalasi 67 PT HARSEN FUSALTRAX sirup kering 68 PT Pyridam Farma Tbk Vibramox sirup kering 69 PT. Indofarma, tbk Sodium Diklofenak tablet
salut enterik 70 PT. Mahakam Beta Farma VASODRIN injeksi 71 PT. Mahakam Beta Farma EPHEDRINE HCl injeksi 72 PT Kalbe Farma Provelyn 75 kapsul 73 PT Kalbe Farma Provelyn 150 kapsul 74 PT Kalbe Farma Provelyn 75 kapsul
CADANGAN RENEWAL OC
No. PENDAFTAR NAMA OBAT TANGGAL BERAKHIR NIE
1 PT. Hexpharm Jaya CAPTOPRIL 12,5 27-Agust-17
2 PT Indofarma Lincomycin 05-Sep-17
3 PT. Phapros, Tbk Ecosol NaCl 05 September 2017
4 PT. Phapros, Tbk Ecosol G5 5 September 2017
5 PT Sanbe Farma FUNTAS 06-Sep-17
6 PT. Indofarma Gemfibrozil 6 september 2017
7 PT Indofarma ACYCLOVIR 400 12-Sep-17
8 PT Indofarma ACYCLOVIR 200 12-Sep-17
9 PT. PERTIWI AGUNG LAMETIC 4 12-Sep-17
10 PT. PERTIWI AGUNG LAMETIC 8 12-Sep-17
11 PT. Hexpharm Jaya, Bekasi DANASONE 12-Sep-17 12 PT. Hexpharm Jaya CETIRIZINE HCL 12-Sep-17 13 PT. Hexpharm Jaya, Bekasi Forten 12.5 12 Sep 2017 14 PT. TUNGGAL IDAMAN
ABDI
CYCLOFEM suspensi injeksi 12 September 2017 15 PT. TUNGGAL IDAMAN
ABDI
CYCLOFEM 12 September 2017
16 PT GRACIA PHARMINDO GRAPHALAC 12 september 2017
17 PT. INTERBAT TRIAMCORT 09/25/2017 00:00:00
18 PT BUFA ANEKA EKACETOL 500 25-09-2017
19 PT BUFA ANEKA TEAMIC 25-09-2017
20 PT Kalbe Farma POVIRAL 01-Okt-17
21 PT. Mahakam Beta Farma VOMETRON 8 01-10-2017 22 PT. Mahakam Beta Farma VOMETRON 4 01-10-2017 23 PT Nufarindo Gitaramin kaptab salut
selaput
02-10-2017
24 PT Nufarindo Gitaramin 02-10-2017
25 PT Indofarma Mineral Mix 3 Oktober 2017
26 Erlimpex erphatrim forte 04-10-2017
27 PT Ferron Par Pharmaceuticals Tenapril 2.5 05-Okt-17 28 PT Ferron Par Pharmaceuticals Tenapril 5 05-Okt-17 29 PT Indofarma Doxyxycline Hyclate 08-Okt-17
30 PT. INTERBAT INTERZOL 10/15/2019 00:00:00 31 PT Nufarindo Stavit 18-10-2017 32 PT PABRIK PHARMASI ZENITH FLUMIN PLUS 30-Okt-17 33 PT Soho Industri Pharmasi Cedantron 30-Okt-17
34 PT GRACIA PHARMINDO ZEMINDO 30-Okt-17
35 PT Kalbe Farma Gemcikal 200 mg 30-Okt-17
36 PT Kalbe Farma Gemcikal 1000 mg 30-Okt-17 37 PT.Ethica Industri Farmasi PECTOCIL DS 30/10/2017
38 PT Indofarma CAPTOPRIL 50 05-Nop-17
39 PT. Hexpharm Jaya TIBIGON 05-Nop-17
40 PT Guardian Pharmatama Cefixime trihydrate 12-Nop-17
41 PT. PHAROS INDONESIA OZEN 12-11-2017
42 PT Ikapharmindo Putramas Lactulax sirup 13-11-2017 43 PT. IKAPHARMINDO
PUTRAMAS
IKANEURON 5000 injeksi 13-11-2017
44 PT.Promedrahardjo FI Ranitidin 13-11-2017
45 PT Galenium Pharmasia lab CALACORT 14-Nop-17 46 PT.Pharos Indonesia Ascardia tablet salut enterik
80
14-11-2017 47 PT.Pharos Indonesia Ascardia tablet salut enterik
160
14-11-2017
48 PT Indofarma Furosemide 12 November 2017
49 PT MEPROFARM INTUNAL 12 NOVEMBER 2017
50 PT. Pratapa Nirmala Granisetron 1 13 November 2017
51 PT. PRATAPA NIRMALA BIPRO 17 November 2017
52 PT Kalbe Farma provelyn 75 23 November 2017
53 PT Kalbe Farma Provelyn 150 23 November 2017 54 PT. Pratapa Nirmala Renagas 30 November 2017
55 PT. Kalbe Farma Kalbutol 5 November 2017
56 PT Indofarma Indoralyt 8 November 2017
57 PT. PRATAPA NIRMALA DEGRANI 3 + GENERIK 13 NOVEMBER 2017 58 PT. IKAPHARMINDO PUTRAMAS Pantoprazole 23-11-2017 59 PT. IKAPHARMINDO PUTRAMAS PANDECTA 23-11-2017
60 PT. Dexa Medica Glumin XR 29-11-2017
61 PT Ikapharmindo Putramas AQUA PRO INJECTION 29-11-2017
62 PT Indofarma Erithromycin 3 Desember 2017
63 PT. Kalbe Farma Mycoral 15 G & 5 G 05-Des-17
64 PT MEPROFARM PYREXIN 80 5 DESEMBER 2017
65 PT MEPROFARM PYREXIN 160 5 DESEMBER 2017
66 PT MEPROFARM PYREXIN 80 5 Desember 2017
67 PT Ferron Trixim kapsul 100 10-Des-17
68 PT Ferron Trixim sirup kering 10-Des-17
69 PT. Dipa Pharmalab Intersains
Molesco 5 10 Desember 2017
70 PT. Roi Surya Prima Farma SKINOVIT 14-12-2017 71 PT. Hexpharm Jaya, Bekasi Lambucid 17 Dec 2017 72 PT. SAMPHARINDO
PERDANA
CALKOMIR 21-12-2017
73 Konimex Inzana 26-Des-17
74 TROPICA MAS PHARMACEUTICALS TROVIAKOL 31-Des-17 75 TROPICA MAS PHARMACEUTICALS ZULTROP KAPTAB 31-Des-17 76 TROPICA MAS
PHARMACEUTICALS ZULTROP FORTE 31-Des-17
77 Konimex DIPROSTA 31-Des-17
78 Konimex ASKAMEX 31-Des-17
79
PT. Combiphar Iron (III)-Hydroxide Polymaltose Complex ~ Iron (III) 100 mg
Folic Acid 0.35 mg 31-Des-17
80 PT. METISKA FARMA XEPANEURON 31-Des-17
81 TROPICA MAS PHARMACEUTICALS PYCAMETH 31-Des-17 82 TROPICA MAS PHARMACEUTICALS ZULTROP SUSPENSI 31-Des-17
83 PT. Kalbe Farma Anaprin 31-Des-17
84 PT. Phyto Kemo Agung Farma
Isoniazid tablet 100 31 Desember 2017 85 PT. Phyto Kemo Agung
Farma
Isoniazid tablet 300 31 Desember 2017 86 PT. Pratapa Nirmala,
Tangerang
FIXACEP 200 31 Desember 2017
87 PT. Metiska Farma Penagon 31 Desember 2017
88 PT. Metiska Farma Cough En Plus 31 Desember 2017 89 PT. Supra Ferbindo Farma OSKADON 31 Desember 2017 90 PT.Ethica Industri Farmasi CETADOP 31-12-17 91 PT Combiphar X-Flam tablet salut gula 31-12-2017 92 PT Holi Pharma IBUPROFEN kaptab 31-12-2017 93 PT. Pharos Indonesia liposin salep 31-12-2017 94 PT. Pharos Indonesia Biostatik tablet salut selaput 31-12-2017 95 PT. Universal Pharmaceutical
Industries
Antasida Doen tablet 31-12-2017 96 PT. Rama Emerald Multi
Sukses
Eryra 31-12-2017
97 PT. NOVAPHARIN Metamizole Sodium 31-12-2017
98 PT. NOVAPHARIN Novaron 31-12-2017
99 PT. PHAROS INDONESIA POLYSILANE 100 ML 31-12-2017
100 PT Combiphar Promactil 31-12-2017
101 PT. PHAROS INDONESIA POLYSILANE 100 ML 31-12-2017 102 PT. PHAROS INDONESIA POLYSILANE 100 ML 31-12-2017
103 PT. Pratapa Nirmala Nokoba 31-12-2017
104 PT. Pratapa Nirmala Laxasium 31-12-2017
105 PT. Pratapa Nirmala Nasaflam 50 31-12-2017 106 PT ETHICA INDUSTRI FARMASI METHYLERGOMETRINE MALEATE 31-12-2017 107 PT ETHICA INDUSTRI FARMASI MYOMERGIN 31-12-2017 108 PT ETHICA INDUSTRI FARMASI ETHIFERAN 31-12-2017 109 PT ETHICA EPINEPHRINE 31-12-2017
110 PT ETHICA CALCIUM GLUCONATE 31-12-2017
111 PT. Berlico Mulia Farma LICOKLOR 31-12-2017
112 PT Combiphar Ribunal 31-12-2017
113 PT. Roi Surya Prima Farma SKINOVIt 04-01-2018 114 PT. IMMORTAL
PHARMACEUTICAL LABORATORIES
NYGROX 18-01-2018
