JADWAL PELAYANAN REGISTRASI VARIASI DAN RENEWAL OBAT COPY Untuk Resubmit Renewal agar mendaftar langsung di loket gedung B/ Tanpa mengirim Email. REGISTRASI VARIASI OC No. Tanggal Pendaftar Produk 1 Senin, 22 Mei 2017 TROPICA MAS OBH TROPICA EXPECTORANT ANAK RASA MADU (Botol @ 60 ml Botol @ 100 ml) 08.30 2 Senin, 22 Mei 2017 TROPICA MAS NEW ANTIDES 09.00 3 Senin, 22 Mei 2017 PT. MERSIFARMA TM CLONAZEPAM 09.30 4 Senin, 22 Mei 2017 PT. MERSIFARMA TM RIKLONA 2 10.00 5 Senin, 22 Mei 2017 PT. DEXA MEDICA AZOMAX 500 Kaptab Salut Selaput 10.30 6 Senin, 22 Mei 2017 PT. DEXA MEDICA GLUMIN XR Kaptab Pelepasan Lambat 13.00 7 Senin, 22 Mei 2017 PT BIMA MITRA FARMA BIMASTAN 500 Kaptab Salut Selaput 13.30 8 Senin, 22 Mei 2017 PT. PROMEDRAHARDJO FI PROTECLINE Cairan Injeksi 14.00 9 Senin, 22 Mei 2017 PT. HEXPHARM JAYA CEFIXIME Kapsul 14.30 10 Senin, 22 Mei 2017 PT. Combiphar OBH Combi Batuk Berdahak 15.00 No. Tanggal Pendaftar Produk 1 Selasa, 23 Mei 2017 PT. GUARDIAN NALETAL 50 08.30 2 Selasa, 23 Mei 2017 PT. GUARDIAN NALETAL 100 09.00 3 Selasa, 23 Mei 2017 PT. MULIA FARMA SUCI ORARHEUMA 09.30 4 Selasa, 23 Mei 2017 PT BERNOFARM RANITIDINE HCL 10.00 5 Selasa, 23 Mei 2017 PT Bernofarm BENOCETAM 10.30 6 Selasa, 23 Mei 2017 PT. Indofarma cyanocobalamin 13.00 7 Selasa, 23 Mei 2017 PT. Graha Farma PRO ATP 13.30 8 Selasa, 23 Mei 2017 PT. Pratapa Nirmala, CALLUSOL 14.00 Tangerang 9 Selasa, 23 Mei 2017 PT. Metiska Farma ASAMNEX 14.30 10 Selasa, 23 Mei 2017 PT. Darya-Varia Laboratoria Tbk ketorolac tromethamol 15.00 RESUBMIT VARIASI OC No. Tanggal Pendaftar Produk 1 Senin, 22 Mei 2017 PT. CORONET CROWN ULTILOX 08.30 2 Senin, 22 Mei 2017 PT. TRIFA RAYA LABORATO Trifastan 09.00 3 Senin, 22 Mei 2017 PT NOVELL PHARMACEUTICORIS 09.30 4 Senin, 22 Mei 2017 PT PRATAPA NIRMALA Bromhexine HCl 10.00 5 Senin, 22 Mei 2017 10.30 6 Senin, 22 Mei 2017 13.00 7 Senin, 22 Mei 2017 13.30 8 Senin, 22 Mei 2017 14.00 9 Senin, 22 Mei 2017 14.30 10 Senin, 22 Mei 2017 15.00
No. Tanggal Pendaftar Produk 1 Selasa, 23 Mei 2017 08.30 2 Selasa, 23 Mei 2017 09.00 3 Selasa, 23 Mei 2017 09.30 4 Selasa, 23 Mei 2017 10.00 5 Selasa, 23 Mei 2017 10.30 6 Selasa, 23 Mei 2017 13.00 7 Selasa, 23 Mei 2017 13.30 8 Selasa, 23 Mei 2017 14.00 9 Selasa, 23 Mei 2017 14.30 10 Selasa, 23 Mei 2017 15.00 RENEWAL OC No. Tanggal Pendaftar Produk 1 Senin, 22 Mei 2017 PT. Harsen Laboratories Decadol 08.30 2 Senin, 22 Mei 2017 PT. PHAROS INDONESIA REPLIGEN 09.00 3 Senin, 22 Mei 2017 PT GUARDIAN PHARMATAM Nuzole 09.30 4 Senin, 22 Mei 2017 PT GUARDIAN PHARMATAM Lanzoprazole 10.00 5 Senin, 22 Mei 2017 PT. Pharos Indonesia Retrogest 10.30 6 Senin, 22 Mei 2017 PT. Bernofarm ALLOPURINOL 13.00 7 Senin, 22 Mei 2017 PT. BERNOFARM RIFABIOTIC 13.30 8 Senin, 22 Mei 2017 PT Dexa Medica Folamil 14.00 9 Senin, 22 Mei 2017 PT. Dipa Pharmalab IntersainsPUSPADROXILE 14.30 10 Senin, 22 Mei 2017 PT. ERRITA PHARMA ETAFLOX 15.00 No. Tanggal Pendaftar Produk 1 Selasa, 23 Mei 2017 PT. Bernofarm TARONTAL 08.30 2 Selasa, 23 Mei 2017 PT. Tunggal Idaman Abdi MAGNIDICON 09.00 3 Selasa, 23 Mei 2017 PT. Kalbe Farma Mycoral 09.30 4 Selasa, 23 Mei 2017 PT MEPROFARM PYREXIN 160 10.00 5 Selasa, 23 Mei 2017 PT MEPROFARM PYREXIN 80 10.30 6 Selasa, 23 Mei 2017 PT SANBE FARMA CROM/OPHTAL (re/submit) 13.00 7 Selasa, 23 Mei 2017 PT SOHO INDUSTRI PHARMAMagard FA 13.30 8 Selasa, 23 Mei 2017 PT Pyridam Farma Tbk. Neuraxon 5000 14.00 9 Selasa, 23 Mei 2017 PT Guardian Pharmatama Teranol 14.30 10 Selasa, 23 Mei 2017 PT. CORONET CROWN ULTILOX FORTE 15.00 No. Tanggal Pendaftar Produk 1 Rabu, 24 Mei 2017 PT Yarindo Farmatama Salbutamol 4 08.30 2 Rabu, 24 Mei 2017 PT. CORONET CROWN COROSORB 09.00 3 Rabu, 24 Mei 2017 PT. PYRIDAM FARMA TYRAN 09.30 4 Rabu, 24 Mei 2017 PT. Solas Langgeng FLAMOXI 10.00 5 Rabu, 24 Mei 2017 PT.Faratu Medisio 10.30 6 Rabu, 24 Mei 2017 PT. Solas Langgeng FLAMOXI 13.00 7 Rabu, 24 Mei 2017 PT. Imfarmind Farmasi IFIDEX 0.5 BOTOL & STRIP Industri 13.30 8 Rabu, 24 Mei 2017 PT. Kalbe Farma Albiotin 300 14.00 9 Rabu, 24 Mei 2017 PT. Kalbe Farma Albiotin 150 14.30 10 Rabu, 24 Mei 2017 PT. Rama Emerald Multi Suks OBH RAMA 15.00 CADANGAN REGISTRASI VARIASI OC No. PENDAFTAR NAMA OBAT 1 PT. MERSIFARMA TM CARBAMAZEPINE 2 PT. MERSIFARMA TM BAMGETOL 200
3 PT. DEXA MEDICA TRANEXAMIC ACID Injeksi 4 PT. GUARDIAN FUNGASOL 5 PT Combiphar Somatostatin Lyomark 6 PT Kalbe Farma Pranza 7 PT. Promedrahardjo FI AMLODIPINE 10 8 PT PRATAPA NIRMALA Bromhexine HCl 9 PT. Kalbe Farma Tbk., Sterile Water for Injection Bekasi 10 PT. Kalbe Farma Tbk., Sterile Water for Injection Bekasi 11 PT Molex Ayus Lexapram 12 PT OTSUKA INDONESIA MEYLON-84 BP 13 PT GUARDIAN ALMEN dan Generiknya 14 PT. Mahakam Beta Farma, Betadine Feminine Hygiene Jakarta 15 PT. Mahakam Beta Farma, Betadine Feminine Hygiene Jakarta 16 PT. Solas Langgeng SINTROL 17 PT Guardian Pharmatama KEREN dan Generiknya 18 PT Guardian Pharmatama Glamarol 1 dan Generiknya 19 PT Guardian Pharmatama Glamarol 4 dan Generiknya 20 PT. Sydna Farma Pacline 21 PT. Promedrahardjo FI AMLODIPINE 5 22 PT BIO KUSUMA Biogen 23 PT BIO KUSUMA Biogen Forte 24 PT. Hexpharm Jaya Bintamox DS 25 PT. Hexpharm Jaya Amoxicillin Trihydrate 26 PT. Hexpharm Jaya ONDANSETRON HCL 2 ML 27 PT. Hexpharm Jaya ONDANSETRON HCL 4 ML 28 PT. Triyasa Nagamas Farma Deponeo 3 ; Obat Suntik KB 1 Tiga Bulanan 29 PT. Promedrahardjo FI LORATADINE 30 PT. Solas Langgeng SINTROL 31 PT. PHAROS INDONESIA POLYSILANE KAPSUL 32 PT Yarindo Farmatama Novaldo 33 PT OTTO Pharmaceutical Pelarut Omeprazole Industries 34 PT Dexa Medica Ramipril OGB 2,5 MG 35 PT Dexa Medica Ramipril OGB 5 MG 36 PT Dexa Medica Hyperil 2.5 37 PT Dexa Medica Hyperil 5 38 PT Ferron Par Tenapril 2.5 39 PT Ferron Par Tenapril 5 40 PT. Dexa Medica Spironolactone 41 PT. Ethica Industri Farmasi Epinephrine 42 PT.Ethica Industri Farmasi KETOROLAC TROMETAMOL 43 PT.Ethica Industri Farmasi Ondansetron HCl Dihydrate 2 ML 44 PT.Ethica Industri Farmasi Ondansetron HCl Dihydrate 4 ML 45 PT Soho Industri Pharmasi Ranitidine HCl 46 PT.Ethica Industri Farmasi CETADOP 47 PT HARSEN MOSAVON 48 PT HARSEN GENTANAL 49 PT. Promedrahardjo FI PROPANZOL
50 PT. Kalbe Farma CLAVAMOX 51 PT. MERSIFARMA TM CLONAZEPAM 52 PT.MERSIFARMA TM INHA 400 53 PT BERNOFARM BROXAL 30 MG/5 ML 54 TRIFA RAYA TRIFADIUM LABORATORIES 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. PERTIWI AGUNG Lanamol 61 PT. Triman TRIDEXON 62 PT. PERTIWI AGUNG Ulvice 63 PT. CORONET CROWN ULTILOX 64 PT.Kimia Farma Tbk Jakarta Cefadroxil 65 PT. Kimia Farma, Bandung TABLET TAMBAH DARAH NEO 66 PT. Finusolprima Farma InternTAXIME 67 PT. PERTIWI AGUNG methisoprinol 68 PT. Triyasa Nagamas Farma tranabat 69 PT.MENARINI INDRIA LABORMUZORAL, Krim 70 PT.MENARINI INDRIA LABORMUZORAL, Tablet 71 PT. Triyasa Nagamas Farma tranaflu 72 PT Ethica Industri Farmasi Calcium Gluconate 73 PT BIO KUSUMA CLINCIN 150 74 PT BIO KUSUMA CLINCIN 300 CADANGAN RENEWAL OC No. PENDAFTAR NAMA OBAT TANGGAL BERAKHIR NIE 1 PT SANBE FARMA GEMCITABINE 200 24/08/17 2 PT. Hexpharm Jaya Anfuhex Cream 24/08/17 3 PT. Pharos Indonesia AVOCEL 27/08/17 4 PT. Hexpharm Jaya Ketoconazole 27/08/17 5 PT. Hexpharm Jaya CAPTOPRIL 12,5 27/08/17 6 PT. Triyasa Nagamas Farma Valenor 2 05/09/17 7 PT Indofarma Lincomycin 05/09/17 8 PT.Pharos Indonesia Vandavir 06/09/17 9 PT Sanbe Farma FUNTAS 06/09/17 10 PT Indofarma ACYCLOVIR 400 12/09/17 11 PT Indofarma ACYCLOVIR 200 12/09/17 12 PT. PERTIWI AGUNG LAMETIC 4 12/09/17 13 PT. PERTIWI AGUNG LAMETIC 8 12/09/17 14 PT. Hexpharm Jaya, Bekasi DANASONE 12/09/17 15 PT. Hexpharm Jaya CETIRIZINE HCL 12/09/17 16 PT.ARMOXINDO FARMA ARCAMOX 250 26/09/17 17 PT. Futamed Fudo 27/09/17 18 PT Kalbe Farma POVIRAL 01/10/17 19 PT. Pratapa Nirmala Neurolin 500 03/10/17 20 PT. Pratapa Nirmala NEUROLIN 500 03/10/17 21 PT Ferron Par Tenapril 5 05/10/17 22 PT Indofarma Doxyxycline Hyclate 08/10/17 23 PT. Ikapharmindo Putramas ULSICRAL 09/10/17 24 PT. Medifarma Laboratories Obimin AF 12/10/17 25 PT PABRIK PHARMASI FLUMIN PLUS ZENITH 30/10/17 26 PT Soho Industri Pharmasi Cedantron 30/10/17 27 PT GRACIA PHARMINDO ZEMINDO 30/10/17 28 PT Kalbe Farma Gemcikal 200 mg 30/10/17 29 PT Kalbe Farma Gemcikal 1000 mg 30/10/17
30 PT Indofarma CAPTOPRIL 50 05/11/17 31 PT. Hexpharm Jaya TIBIGON 05/11/17 32 PT FERRON Cameloc 08/11/17 33 PT FERRON Cameloc 08/11/17 34 PT MEPROFARM DEOLIT 12/11/17 35 PT Medifarma Laboratories ENZYPLEX (Khusus Ekspor) 12/11/17 36 PT MEPROFARM INTUNAL 12/11/17 37 PT Guardian Pharmatama Cefixime trihydrate 12/11/17 38 PT. Ikapharmindo Putramas IKANEURON 5000 13/11/17 39 PT.Pharos Indonesia Narfoz 4 14/11/17 40 PT. Ferron Par PharmaceuticaGRAVOMIT 14/11/17 41 PT Galenium Pharmasia lab CALACORT 14/11/17 42 PT Widatra Bhakti Dextrose 10% 22/11/17 43 PT WIDATRA BHAKTI DEXTROSE 10% 22/11/17 44 PT. Ikapharmindo Putramas PANDECTA 23/11/17 45 PT. Ikapharmindo Putramas PANTOPRAZOLE 23/11/17 46 PT. Dipa Pharmalab IntersainsGABESCO 28/11/17 47 PT Ikapharmindo Putramas Aqua pro injection 29/11/17 48 PT Meprofarm INTUNAL 05/12/17 49 PT MEPROFARM PYREXIN 80 05/12/17 50 PT. Kalbe Farma Mycoral 15 G & 5 G 05/12/17 51 PT. Phapros, Tbk Aqua Pro Injectione 10/12/17 52 PT Ferron Trixim kapsul 100 10/12/17 53 PT Ferron Trixim sirup kering 10/12/17 54 Konimex Inzana 26/12/17 55 PT. SUMBER KESEHATAN BPuder Obat Sakit Kepala cap"3 56 PT. NOVAPHARIN TETRAyICLINE HCL 57 PT. Pharos Indonesia POLYSILANE SUSPENSI 58 PT.Ethica Industri Farmasi EXTRACAINE 59 PT Sanbe Farma BIOTHICOL 250 60 PT. NOVAPHARIN METAMIZOLE SODIUM 61 PT. NOVAPHARIN NOVARON 62 TROPICA MAS TROVIAKOL 63 TROPICA MAS ZULTROP KAPTAB 64 TROPICA MAS ZULTROP FORTE 65 Konimex DIPROSTA 66 Konimex ASKAMEX 67 PT. Combiphar Iron (III)/Hydroxide Polymaltose Complex ~ Iron (III) 100 mg Folic Acid 0.35 mg 68 PT. METISKA FARMA XEPANEURON 69 TROPICA MAS PYCAMETH 70 TROPICA MAS ZULTROP SUSPENSI 71 PT. Kalbe Farma Anaprin 72 PT. ROI SURYA PRIMA FARMSKINOVIT 14/12/017 73 PT. ROI SURYA PRIMA FARMSKINOVIT 04/01/18 74 PT. ROI SURYA PRIMA FARMSKINOVIT 04/01/18 75 PT MEPROFARM PROCOLIC 22/02/18 76 PT. Phapros, Tbk Chloramphenicol 22/02/18 77 PT. Phapros, Tbk Epinephrine 22/02/18 78 PT. Phapros, Tbk Acyclovir 22/02/18