| A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | AL | Nama Obat | No Aju | Zat aktif dan kekuatan | Bentuk Sediaan | Nama Pendaftar | Nama Produsen Obat Jadi | Kategori Registrasi | Jalur evaluasi | Ketersediaan RMP | Tanggal Diterima RMP | Evaluator | Keterangan | Status registrasi 07/10/2025 | NIE | Tanggal disetujui NIE | Masa Berlaku NIE | Tanggal disetujui SPP | |
2 | 1 | Rozlytrek | EREG10043712200057-58 | Entrecitinib 200 mg | Kapsul | PT. Menarini Indria Laboratories | Mayne Pharma Inc., Greemville, USA untuk F. Hoffmann-La Roche, Ltd., Base, Switzerland | Zat Aktif Baru | 300 HK | 29/05/2023 | Noviana | proses evaluasi mutu penandaan | NIE Disetujui | DKI2457511701A1 dan DKI2457511701B1 | 29/07/2024 | 29/07/2029 | |||
3 | 2 | Paxlovid | EREG10024112300288 | Nirmatrelvir 150 mg;Ritonavir 100 mg | Tablet Salut Selaput | PT. Pfizer Indonesia | PFIZER MANUFACTURING DEUTSCHLAND GMBH | Zat Aktif Baru | 100 HK | 26/05/2023 | Noviana | masih proses praregistrasi | NIE Disetujui | DKI2354201217A1 | 8/12/2023 | 9/12/2028 | |||
4 | 3 | ENVLO | EREG10040112300007 | Enavogliflozin 0.3 mg | Tablet Salut Selaput | PT. Daewoong Infion | DAEWOONG PHARMACEUTICAL CO., LTD, Korea | Zat Aktif Baru | 300 HK | 26/05/2023 | Ghina | proses pengiriman ke evaluator | pemenuhan kelengkapan hasil komnas | ||||||
5 | 4 | Fexuclue | EREG10040112200008 | Fexuprazan hydrochloride 40 mg | Tablet Salut Selaput | PT. Daewoong Infion | DAEWOONG PHARMACEUTICAL CO., LTD, Korea | Zat Aktif Baru | 300 HK | 08/06/2023 | Sofira | proses evaluasi efficacy safety | Ditolak | ||||||
6 | 5 | Sirturo | EREG10006112300083 | BEDAQUILINE FUMARATE 120 mg | Tablet | PT. Soho Industri Farmasi | RECIPHARM PHARMASERVICES PVT. LTD. | Indikasi Posologi Baru | 300 HK | 23/06/2023 | Rina | proses evaluasi efficacy safety | SPP Disetujui | DKI1855203010A2 | 10/2/2023 | 10/2/2028 | 1/11/2023 | ||
7 | 6 | Jakavi | EREG10000512300069-74 | Ruxolitinib Phosphate 5 mg;15 mg;20 mg | Tablet | PT. Novartis Indonesia | Novartis Pharma Stein AG, Stein, Swiss untuk Novartis Pharm AG, Basel, Swiss | Indikasi Posologi Baru | 300 HK | 14/07/2023 | Sofira | proses evaluasi efficacy safety | SPP Disetujui | DKI1567509010A1, DKI1567509010B1, dan DKI1567509010C1 | 23/11/2020 | 23/11/2025 | |||
8 | 7 | EP-FENO | EREG10030312200280 | Fenofibrate 145 mg | Tablet | PT. Kimia Farma | ETHYPHARM | Bentuk Sediaan Baru | 300 HK | 04/07/2023 | Sofira | proses evaluasi mutu penandaan | proses evaluasi mutu penandaan | ||||||
9 | 8 | Gavreto | EREG10043712100165-66 | Pralsetinib 10 mg | Kapsul | PT. Menarini Indria Laboratories | CATALENT CTS, LLC | Zat Aktif Baru | 300 HK | 07/07/2023 | Rina | proses evaluasi mutu penandaan | Pembatalan NIE dari Pendaftar | ||||||
10 | 9 | Diprivan | A | Propofol 200 mg | Injeksi | PT. MITSUBISHI TANABE PHARMA INDONESIA | CORDEN PHARMA S.P.A | Indikasi Posologi Baru | 300 HK | 14/07/2023 | Sofira | proses evaluasi efficacy safety | Ditolak | ||||||
11 | 10 | Bacrelba | EREG10000512300044-45 | Asciminib 20 mg;40 mg | Tablet Salut Selaput | PT. Novartis Indonesia | NOVARTIS PHARMA STEIN AG | Zat Aktif Baru dan Kombinasi Baru | 300 HK | 25/07/2023 | Sofira | proses evaluasi efficacy safety | NIE Disetujui | DKI2467600117A1 dan DKI2467600117B1 | 22/05/2024 | 22/05/2029 | |||
12 | 11 | Bunafen RTU | EREG10024312200077 | Ibuprofen 4 mg | Cairan Untuk Infus | PT. Fresenius Kabi Combiphar | RESENIUS KABI POLSKA SP. Z O.O. | Bentuk Sediaan Baru | 300 HK | 31/08/2023 | Sofira | proses evaluasi efficacy safety | Evaluasi mutu penandaan | ||||||
13 | 12 | Lynparza | EREG10042212300234-35 | Olaparib 10 mg;15 mg | Tablet Salut Selaput | PT. Astrazeneca Indonesia | ABBVIE LIMITED | Indikasi Posologi Baru | 120 HK | 29/09/2023 | Rina | proses evaluasi efficacy safety | SPP Disetujui | DKI2159602717A1 dan DKI2159602717B1 | 2/22/2021 | 2/2/2026 | 16/03/2024 | ||
14 | 13 | Xtandi | EREG10025512300071 | Enzalutamide | Kapsul Lunak | PT. Meprofarm | CATALENT PHARMA SOLUTIONS, LLC, USA | Indikasi Baru | 300HK | 29/09/2023 | Noviana | proses evaluasi efficacy safety | SPP Disetujui | DKI1717400102A1 | 3/10/2022 | 3/10/2027 | 27/12/2023 | ||
15 | 14 | Promag Progerd | EREG10022112300409 | SODIUM BICARBONATE 267 mg; CALCIUM CARBONATE 160 mg; SODIUM ALGINATE 500 mg | Suspensi | PT. Kalbe Farma | PT. Kalbe Farma | Kombinasi Baru | 300HK | 29/09/2023 | Anindya | proses evaluasi efficacy safety | NIE Disetujui | DTL2611649233A1 | 16/03/2026 | 16/03/2031 | |||
16 | 15 | Lenvima | EREG17180812300010-11 | LENVATINIB MESILATE 4,90 mg | Kapsul | PT. EISAI INDONESIA | PATHEON INC, Canada | Indikasi Posologi Baru | 300 HK | 29/09/2023 | Mayerni | proses evaluasi efficacy safety | Evaluasi efikasi keamanan | ||||||
17 | 16 | Firialta | EREG10036612300116-119 | Finerenone 10.00 mg; 20.00 mg | Tablet Salut Selaput | PT. Bayer Indonesia | BAYER AG | Indikasi Baru | 120 HK | 24/10/2023 | Ghina | proses evaluasi efficacy safety | Proses appeal | ||||||
18 | 17 | Utrogestan | EREG10021912300039-40 | Progesterone 200 mg | Kapsul Lunak | PT. Sydna Farma | OLIC (THAILAND) LIMITED | Indikasi Posologi Baru | 300 HK | 24/10/2023 | Ratna | proses evaluasi efficacy safety | SPP Disetujui | DKI2045900202B1 | 29/07/2020 | 29/07/2025 | 26/04/2025 | ||
19 | 18 | Jardiance | EREG10036412300127-28 | Empagliflozin 10 mg | Tablet Salut Selaput | Boehringer Ingelheim Indonesia | ROTTENDORF PHARMA GMBH | Indikasi Posologi Baru | 120 HK | 27/11/2023 | Anindya | proses evaluasi efficacy safety | Evaluasi penandaan | ||||||
20 | 19 | Forxiga | EREG10042212300149-150 | DAPAGLIFLOZIN PROPANEDIOL 10 mg dan 5 mg | Tablet Salut Selaput | PT. Astra Zeneca | ASTRAZENECA PHARMACEUTICALS LP | Indikasi Posologi Baru | 120 HK | Ratna | Proses evaluasi penandaan | SPP Disetujui | DKI1735301317A1 | 05/10/2022 | 05/10/2027 | 13/02/2024 | |||
21 | 20 | Tacsograf | EREG10006112200127 | Tacrolimus 5 mg | Kapsul | PT. SOHO INDUSTRI PHARMASI | CONCORD BIOTECH LTD. | Kekuatan Baru | 300 HK | 12/12/2023 | Sofira | Proses evaluasi mutu penandaan | NIE Disetujui | DKI2355900301A1 | 16/12/2023 | 16/12/2028 | |||
22 | 21 | Fycompa | EREG17180812200009-11 | Perampanel 2 mg | Tablet Salut Selaput | PT. EISAI INDONESIA | EISAI MANUFACTURING LIMITED, HATFIELD, United Kingdom | Indikasi Posologi Baru | 300 HK | 12/12/2023 | Anindya | Proses evaluasi mutu penandaan | SPP Disetujui | DKI1849600117A1 | 6/9/2019 | 6/9/2024 | 31/12/2023 | ||
23 | 22 | Latuda | EREG10019312100091-93 | Lurasidone HCl 20 mg | Tablet Salut Selaput | PYRIDAM FARMA TBK | BUSHU PHARMACEUTICALS LTD., JAPAN | Zat Aktif Baru | 300 HK | 12/12/2023 | Anindya | Proses evaluasi mutu penandaan | NIE Disetujui | DKI2345900317A1 | 28/12/2023 | 28/12/2028 | |||
24 | 23 | Prolutex | EREG10026012100540 | Progesterone 25 mg | Larutan Injeksi | DEXA MEDICA | IBSA INSTITUT BIOCHIMIQUE SA, SWITZERLAND | Bentuk Sediaan Baru | 300 HK | 18/12/2023 | Anindya | Proses evaluasi mutu penandaan | NIE Disetujui | DKI2467200143A1 | 18/03/2024 | 18/03/2029 | |||
25 | 24 | Innovair Nexthaler | EREG10015512300007 | Beclometasone dipropionate 0.100 mg; Formoterol fumarate dihydrate 0.006 mg | Serbuk inhaler | PT. Tunggal Idaman Abdi | Chiesi Farmaceutici S.p.A., Parma, Italy | Indikasi Posologi Baru | 300 HK | 01/01/2024 | Anindya | proses evaluasi efficacy safety | SPP Disetujui | DKI2060600667A1 | 08/07/2020 | 08/07/2025 | 22/10/2024 | ||
26 | 25 | Pansiptin | EREG10027212200018-19 | Sitagliptin Hydrochloride 50 dan 100 mg | Tablet Salut Selaput | PT. Mega lifesciences Indonesia | SAG MANUFACTURING, S.L.U | Registrasi Zat Aktif Baru(Bentuk Sediaan Garam Baru) | 300 HK | 03/01/2024 | Sofira | Proses evaluasi mutu penandaan | NIE Disetujui | DKI2467300117A1 dan DKI2467300117B1 | 05/04/2024 | 05/04/2029 | |||
27 | 26 | Gogaz | EREG10027212100067 | Simethicone 200 mg | Kapsul Lunak | PT. Mega lifesciences Indonesia | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | Bentuk sediaan baru dan kekuatan baru | 300 HK | 04/01/2024 | Ghina | Proses evaluasi penandaan | NIE Disetujui | DKI2460600302A1 | 06/07/2024 | 06/07/2029 | |||
28 | 27 | Sidapvia | EREG10042212300382 | Dapagliflozin 10 mg; Sitagliptin 100 mg | Tablet Salut Selaput | PT. Astra Zeneca | SK CHEMICALS CO.,LTD. (1346), SOUTH KOREA | Kombinasi Baru | 300 HK | 12/12/2023 | Noviana | proses evaluasi efficacy safety | NIE Disetujui | ||||||
29 | 28 | Noltec | EREG10031212100153 | Ilaprazole 10 mg | Tablet salut enterik | PT Sanbe Farma | IL-YANG BIOPHARM, CO., LTD | Zat aktif baru | 300 HK | 24/01/2024 | Sofira | Proses evaluasi mutu penandaan | NIE Disetujui | DKI2467500115A1 | 07/05/2024 | 07/05/2029 | |||
30 | 29 | Akeega | EREG10037412300122-123 | Niraparib 50 mg / Abiraterone Acetate 500 mg dan Niraparib 100 mg / Abiraterone Acetate 500 mg | Tablet Salut Selaput | PT. INTEGRATED HEALTHCARE INDONESIA | PATHEON FRANCE | Kombinasi baru dan zat akti baru | 120 HK | 30/11/2024 | Sofira | proses evaluasi efficacy safety | Pembatalan NIE dari Pendaftar | ||||||
31 | 30 | Imbruvica | EREG10006112200216, EREG10037412200127 | Ibrutinib 140 mg | Tablet Salut Selaput | PT. SOHO INDUSTRI PHARMASI | CILAG AG SWITZERLAND | Indikasi Posologi Baru | 300 HK | 10/1/2024 | Anindya | proses evaluasi efficacy safety | SPP Disetujui | DKI2051100201A1 | 21/01/2022 | 21/01/2027 | 09/05/2025 | ||
32 | 31 | Faslodex | EREG10042212200290 | Fulvestrant 50 mg/ml | Injeksi | PT. Astrazeneca Indonesia | VETTER PHARMA-FERTIGUNG GMBH & CO. KG, Germany | Indikasi Posologi Baru | 300 HK | 29/1/2024 | Anindya | Proses evaluasi penandaan | Evaluasi penandaan | ||||||
33 | 32 | Calcet | EREG10019112200166-168 | Cinacalcet 30 mg; 60 mg ; 90 mg | Tablet Salut Selaput | PT. Pratapa Nirmala | SYNTHON CHILE LTDA., Santiago, Chile | Zat aktif baru | 300 HK | 15/02/2024 | sofira | Proses evaluasi mutu penandaan | NIE Disetujui | DKI2443401717A1 | 23/10/2024 | 23/10/2024 | |||
34 | 33 | Ducressa | EREG10025312200117 | Levofloxacin hemihydrate 5.12 mg/mL ~ Levofloxacin 5.00 mg/ml; Dexamethasone sodium phosphate 1.32 mg/mL ~ Dexamethasone 1.00 mg/ml | Tetes mata | PT. Meiji Indonesian Pharmaceutical Industries | TUBILUX PHARMA S.P.A., POMEZIA, Italy Dirilis Oleh SANTEN OY, , | Kombinasi Baru | 300 HK | 26/02/2024 | sofira | proses evaluasi efficacy safety | Appeal/hearing | ||||||
35 | 34 | NICORETTE FRESHMINT | EREG10037412100097-98 | Nicotine resinate 10.00 mg; 20 MG | Chewing gum | PT. INTEGRATED HEALTHCARE INDONESIA | MCNEIL AB, HELSINGBORG, SWEDEN | Zat Aktif Baru | 300 HK | Ghina | Proses evaluasi mutu penandaan | NIE Disetujui | DTI2366700179A1 | 4/12/2023 | 4/12/2028 | ||||
36 | 35 | Sitazit-M dan SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE / METFORMIN HYDROCHLORIDE | EREG10042512200108-107 | Sitagliptin hydrochloride monohydrate 56,687 mg ~ Sitagliptin 50 mg/Metformin hydrochloride 1000 mg | Tablet Salut Selaput | PT. AMAROX PHARMA GLOBAL | AMAROX PHARMA GLOBAL | Zat Aktif Baru | 300 HK | 12/01/2024 | sofira | Approvable letter | NIE Disetujui | DKL2343503517A1 | 01/02/2024 | 01/02/2029 | |||
37 | 36 | Staquis | EREG10024112300014-15 | CRISABOROLE 2% | Salep | PT. Pfizer Indonesia | PHARMACIA & UPJOHN COMPANY LLC | Zat Aktif Baru | 300 HK | Ratna | Proses evaluasi penandaan | Evaluasi mutu penandaan | DKI2472101230A1 | 13/05/2024 | 13/05/2029 | ||||
38 | 37 | MIRENA | EREG10036612300088 | Levonorgestrel 52 mg | INTRA UTERINE SYSTEM (IUS) | PT. Bayer Indonesia | BAYER OY - Finland | Posologi Baru | 100 HK | Ratna | Proses evaluasi penandaan | SPP Disetujui | DKI0775601476A1 | 14/10/2022 | 14/10/2027 | 8/8/2024 | |||
39 | 38 | Fentalid | EREG10030312300338-40 | Fentanyl citrate 110 μg ~ Fentanyl 67 μg Fentanyl citrate 210 μg ~ Fentanyl 133 μg Fentanyl citrate 420 μg ~ Fentanyl 267 μg | Tablet sublingual | PT. Kimia Farma | Ethypharm, Le Grand Quevilly, France | Bentuk sediaan baru, indikasi posologi baru, dan kekuatan baru | 300 HK | Ratna | proses evaluasi efficacy safety | Penerbitan SK KOMNAS | |||||||
40 | 39 | Precedex | EREG10024112300464 | Dexmedetomidine hydrochloride 118 mcg ~ Dexmedetomidine 100 mcg/ml | Injeksi | PT. Pfizer Indonesia | Hospira Inc., Rocky Mount, USA | Indikasi Posologi Baru | 300 HK | Ratna | proses evaluasi efficacy safety | Evaluasi efikasi keamanan | DKI1811901443A1 | 20/08/2024 | 20/08/2029 | 03/02/2026 | |||
41 | 40 | AMARYL-M | EREG10002212300642-43 | Glimepiride 1 mg; Metformin HCl 250 mg Glimepiride 2 mg; Metformin HCl 500 mg | Tablet Salut Selaput | AVENTIS PHARMA | HANDOK INC. - Republic Of Korea | Posologi Baru dan Kekuatan Baru | 300 HK | Ratna | proses evaluasi efficacy safety | Evaluasi efikasi keamanan | |||||||
42 | 41 | Qtern | EREG10042212300081 | Dapagliflozin 10 mg; Saxagliptin 5 mg | Tablet Salut Selaput | PT. Astrazeneca Indonesia | STRAZENECA PHARMACEUTICALS LP, MOUNT VERNON, United States of America Dikemas dan Dirilis Oleh ASTRAZENECA AB, , | Kombinasi baru | 300 HK | 19/03/2024 | sofira | Evaluasi efikasi keamanan | NIE Disetujui | DKI2451304617A1 | 29/04/2024 | 29/04/2025 | |||
43 | 42 | Esbriet | EREG10043712200008-09 | Pirfenidone 267.0 mg | Tablet Salut Selaput | PT. Menarini Indria Laboratories | DELPHARM MILANO S.R.L, MILAN, Italy Dirilis Oleh F. HOFFMANN-LA ROCHE LTD | bentuk sediaan baru dengan Kekuatan Baru | 300 HK | 13/02/2024 | sofira | Proses evaluasi penandaan | NIE Disetujui | DKI2457511617A1 dan DKI2457511617A1 | 05/04/2024 | 05/04/2029 | |||
44 | 43 | Labetalol Hydrochloride | EREG10040712100078 | Labetalol hydrochloride 5 mg | Injeksi | PT. ETHICA INDUSTRI FARMASI (SITE JABABEKA | ETHICA INDUSTRI FARMASI (SITE JABABEKA), BEKASI | Zat Aktif Baru | 300 HK | 22/03/2024 | Rina/Sofi | NIE disetujiu | NIE Disetujui | DKL2033550481A1 | 15/08/2024 | 15/08/2024 | |||
45 | 44 | Morfikaf dan Morphine Sulfate Pentahydrate | EREG10030312300063-62 | Morphine Sulfate Pentahydrate | Sirup | PT Kimia Farma | PT Kimia Farma | Bentuk sediaan baru | 300 HK | Noviana | NIE disetujiu | NIE Disetujui | DNL2412433937A1 dan GNL2412434037A1 | 18/04/2024 | 18/04/2026 | ||||
46 | 45 | ABILIFY ASIMTUFII | EREG1002140102400016-17 | Aripiprazole | SUSPENSI INJEKSI PELEPASAN LAMBAT | OTSUKA INDONESIA | Pra Reg | ||||||||||||
47 | 46 | Motilium | EREG10002012100033 | Domperidone 10 mg | Tablet Salut Selaput | TAISHO PHARMACEUTICAL INDONESIA | TAISHO PHARMACEUTICAL INDONESIA | Posologi Baru | 300 HK | Ratna | SPP Disetujui | SPP Disetujui | DKL1124401017A1 | 25/11/2020 | 25/11/2025 | 04/04/2024 | |||
48 | 47 | INAPLANT | EREG10022912400004 | Levonorgestrel 150 mg | SUBDERMAL IMPLANTS | PT. Catur Dakwah Crane Farmasi | Catur Dakwah Crane Farmasi, Bogor, Indonesia | kekuatan baru | 300 HK | 14/05/2024 | sofi | proses evaluasi efficacy safety | Evaluasi efikasi keamanan | ||||||
49 | 48 | Colistic | EREG10008712300234 | Colistimethate Sodium 2 MIU | SERBUK INJEKSI | PT. DARYA-VARIA LABORATORIA TBK | ALTAN PHARMACEUTICALS, S.A. | Zat Aktif Baru | 300 HK | Ratna | Evaluasi efikasi keamanan | Evaluasi efikasi keamanan | |||||||
50 | 49 | Rexulti | EREG10021412200144-49 | Brexpiprazole 0,25; 0,5; 1; 2; 3; dan 4 mg | Tablet Salut Selaput | PT Otsuka Indonesia | Korea Otsuka Pharmaceutical, Hwaseong-Si, Korea Selatan | 300 HK | 21/05/2024 | Sofi | Evaluasi efikasi keamanan | Evaluasi efikasi keamanan | |||||||
51 | 50 | Prosix | EREG10010412200044 | Cetirizine hydrochloride 10 mg | Oral Dissolving Film | PT Etercon Pharma | ETERCON PHARMA, DEMAK | Bentuk Sediaan baru | 300 HK | 22/05/2024 | Sofi | evaluasi penandaan dan mutu | NIE Disetujui | DTL2415722519A1 | 29/07/2024 | 29/07/2029 | |||
52 | 51 | Ryvel | EREG10010212200022 | Cetirizine hydrochloride 10 mg | Oral Dissolving Film | PT Novell Pharmaceutical Laboratories | ETERCON PHARMA, DEMAK | Bentuk Sediaan baru | 300 HK | 22/05/2024 | Sofi | evaluasi penandaan dan mutu | NIE Disetujui | DTL2433558219A1 | 29/07/2024 | 29/07/2029 | |||
53 | 52 | Tarlige | EREG10002812300050, 53-55, EREG10002812400029-32 | Mirogabalin 2.5 mg, 5 mg, 10 mg, 15 mg | Tablet Salut Selaput | PT. MITSUBISHI TANABE PHARMA INDONESIA. | TAIYO PHARMA TECH CO., LTD, OSAKA, Japan | Zat Aktif Baru | 300 HK | 24/05/2024 | Ghina | evaluasi penandaan dan mutu | NIE Disetujui | ||||||
54 | 53 | Glatofa | EREG10019112300295 | GLATIRAMER ACETATE 20 MG | INJEKSI | PT. PRATAPA NIRMALA | SYNTHON CHILE LTDA. - Chile | Zat Aktif Baru | 300 HK | 28/05/2024 | ratna | Evaluasi efikasi keamanan | Evaluasi efikasi keamanan | ||||||
55 | 54 | Koselugo | EREG10042212400001-2 | SELUMETINIB HYDROGEN SULFATE 30.25 mg; 12,1 mg | Kapsul | PT. ASTRAZENECA INDONESIA | PATHEON PHARMACEUTICALS INC - United States of America | Zat Aktif Baru | 100 HK | 28/05/2024 | ratna | Evaluasi efikasi keamanan | evaluasi penandaan dan mutu | ||||||
56 | 55 | Xtandi* sama beda pengajuan | EREG10025512400006-7 | ENZALUTAMIDE 40 mg;80 mg | Tablet Salut Selaput | PT. MEPROFARM | LONZA BEND INC. - United States of America | Bentuk sediaan baru dengan kekuatan baru | 300 HK | 28/05/2024 | ratna | Evaluasi efikasi keamanan | Pemenuhan SK KOMNAS | ||||||
57 | 56 | Dapcin | EREG10042512400039 | DAPTOMYCIN 500 mg | Serbuk Injeksi | PT. AMAROX PHARMA GLOBAL | ASPIRO PHARMA LIMITED - India | Zat aktif baru | 300 HK | 28/05/2024 | Anin | Evaluasi efikasi keamanan | Evaluasi efikasi keamanan | ||||||
58 | 57 | Sybrava | EREG10000512400026 | INCLISIRAN SODIUM 300 MG | Larutan Injeksi | PT. NOVARTIS INDONESIA | LEK D.D. - Republic of Slovenia | Zat aktif baru | 300 HK | 28/05/2024 | Noverita | Evaluasi efikasi keamanan | NIE Disetujui | DKI2469000143A1 | 30/12/2024 | 30/12/2024 | |||
59 | 58 | BETASERC OD | EREG10034612300174 | BETAHISTINE DIHYDROCHLORIDE 48 MG | Tablet Salut Selaput | PT. ABBOTT INDONESIA | ABBOTT LABORATORIES DE MEXICO, S.A.DE.C.V - Mexico | Bentuk sediaan baru dengan kekuatan baru | 300 HK | 28/05/2024 | Noverita | Evaluasi efikasi keamanan | NIE Disetujui | DKI2671300114A1 | 11/02/2026 | 11/02/2031 | |||
60 | 59 | EREG10000712500022 | EREG10000512400075 | RIBOCICLIB SUCCINATE 254.40 MG | Tablet Salut Selaput | PT. NOVARTIS INDONESIA | NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING PTE. LTD. - Singapore | Perubahan indikasi dan posologi baru | 300 HK | 28/05/2024 | Rina | Evaluasi efikasi keamanan | Evaluasi efikasi keamanan | ||||||
61 | 60 | PLAVIX | EREG10002212400126 | CLOPIDOGREL HYDROGEN SULFATE 97.875 MG | Tablet Salut Selaput | PT. KALVENTIS SINERGI FARMA | KALVENTIS SINERGI FARMA - Indonesia | Perubahan indikasi dan posologi baru | 300 HK | 28/05/2024 | Noverita | Evaluasi efikasi keamanan | SPP Disetujui | DKL1321205717A1 | 01/11/2023 | 09/05/2028 | 09/05/2025 | ||
62 | 61 | Crestor | EREG10042212400108-112 | ROSUVASTATIN CALCIUM 5 MG;10 MG; 20 MG; 40 MG | Tablet Salut Selaput | PT. ASTRAZENECA INDONESIA | IPR PHARMACEUTICAL,INC. PUERTO RICO | Perubahan indikasi dan posologi baru | 300 HK | 29/05/2024 | sofi | Evaluasi efikasi keamanan | Evaluasi efikasi keamanan | ||||||
63 | 62 | Invega | EREG10037412400036-38 | PALIPERIDONE 3 MG;6 MG;12 MG | Tablet Pelepasan Lambat | PT. INTEGRATED HEALTHCARE INDONESIA | ANSSEN CILAG MANUFACTURING LLC | Kekuatan baru dan posologi baru | 300 HK | 28/06/2024 | Rina | Evaluasi efikasi keamanan | Evaluasi efikasi keamanan | ||||||
64 | 63 | Remitch | EREG10025312100045-46 | NALFURAFINE HYDROCHLORIDE 0.0025 MG | Orally Disintegrating Tablet | PT. MEIJI INDONESIAN PHARMACEUTICAL INDUSTRIES | BUSHU PHARMACEUTICALS LTD., MISHIMA, Japan | Zat aktif baru | 300 HK | 28/06/2024 | Rina | Evaluasi efikasi keamanan | NIE Disetujui | DKI2456500581A1 | 07/08/2024 | 07/08/2029 | |||
65 | 64 | Xalkori | EREG10024112300140-142 | Crizotinib 200 mg dan 250 mg | Kapsul | PT. PFIZER INDONESIA | Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany | Posologi baru | 300 HK | 27/06/2024 | Anindya | Evaluasi efikasi keamanan | Evaluasi efikasi keamanan | ||||||
66 | 65 | Addaven | EREG10024312200005 EREG10024312200022 | Tiap 1 ml mengandung: - Chromic chloride hexahydrate 5.33 μg - Cupric chloride dihydrate 0.10 mg - Ferric chloride hexahydrate 0.54 mg - Manganese chloride tetraydrate 19.8 μg - Potassium iodide 16.6 μg - Sodium fluoride 0.21 mg - Sodium molybdate dihydrate 4.85 μg - Sodium selenite anhydrous 1.73 μg - Zinc chloride 1.05 mg | Infus | PT. Fresenius Kabi Combiphar | Fresenius Kabi Norge AS, Halden, Norway | Kombinasi baru | 300 HK | 28/06/2024 | Rina | Evaluasi efikasi keamanan | proses appeal | ||||||
67 | 66 | Physio 140 | EREG10021412100130 | Tiap 500 ml mengandung: - Sodium acetate trihydrate 1.700 g ~ Sodium acetate anhydrate 1.025 g - Sodium acetate trihydrate 1.700 g ~ Sodium acetate anhydrate 1.025 g - Dextrose monohydrate 5.500 g ~ Dextrose anhydrate 5.000 g - Calcium gluconate hydrate 0.337 g - Potassium chloride 0.149 g - Sodium chloride 3.185 g - Sodium citrate hydrate 0.294 g - Magnesium chloride hexahydrate 0.102 g | Infus | PT. OTSUKA INDONESIA | OTSUKA INDONESIA, MALANG | Kombinasi baru | 300 HK | 28/06/2024 | Rina | Evaluasi mutu dan penandaan | Evaluasi mutu dan penandaan | ||||||
68 | 67 | Clonavell ODT | EREG10010212200107 | Clonazepam 2 mg | ORALLY DISINTEGRATING TABLET | PT Novell Pharmaceutical Laboratories | PT Novell Pharmaceutical Laboratories | bentuk sediaan baru | 300 HK | 28/06/2024 | Ratna | Ketua Tim - Validasi Draft NIE | NIE Disetujui | DPL2433557181A1 | 06/07/2024 | 06/07/2029 | |||
69 | 68 | Avigan | EREG10038312300085 | Favipiravir 200 mg | Tablet Salut Selaput | PT. Beta Pharmacon | FUJIFILM TOYAMA CHEMICAL CO., LTD., TOYAMA FACTORY dikemas sekunder di BETA PHARMACON | Zat aktif baru | 300 HK | 30/06/2024 | Rina | Evaluasi mutu dan penandaan | NIE Disetujui | DKI2456200217A1 | 01/10/2024 | 01/10/2029 | |||
70 | 69 | Depakote IV | EREG10034612400131 | Valproic acid 500 mg | INJEKSI | PT. ABBOTT INDONESIA | Olic (Thailand), 166 Bangpa-in Industrial estate, Udomsorayuth road, Moo 16, Bangkrason, Bangpa-in, Ayutthaya, 13160, Thailand | Bentuk Sediaan baru | 300 HK | 30/06/2024 | Sofi | Evaluasi efikasi keamanan | Evaluasi efikasi keamanan | ||||||
71 | 70 | Destavell 5 ODT | EREG10010211800123 | DESLORATADINE 5 mg | ORALLY DISINTEGRATING TABLET | NOVELL PHARMACEUTICAL LABORATORIES | NOVELL PHARMACEUTICAL LABORATORIES, BOGOR, INDONESIA | Bentuk Sediaan baru | 300 HK | 30/07/2024 | Anin | NIE disetujui | NIE Disetujui | DKL2033550481A1 | 15/08/2024 | 15/08/2024 | |||
72 | 71 | ETOPUL | EREG10010212400264 | Etoposide 20 mg | INJEKSI | NOVELL PHARMACEUTICAL LABORATORIES | OREA UNITED PHARM, INC, SEJONG-SI, Republic Of Korea | Perubahan indikasi dan posologi baru | 100 HK | 23/07/2024 | Sofi | NIE disetujui | SPP Disetujui | DKI0616200143A1 | 29/08/2024 | 03/08/2029 | 29/08/2024 | ||
73 | 73 | ARGESUN | EREG10030112400009-10 | Artesunate 60 mg; 180 mg | Serbuk Injeksi + Pelarut | PHARMA LABORATORIES | GUILIN PHARMACEUTICAL CO.,LTD., GUILIN, CHINA | Formulasi baru | 300 HK | 23/07/2024 | Anin | Evaluasi efikasi keamanan | Evaluasi efikasi keamanan | ||||||
74 | 74 | ALECENSA | EREG10043712400191 | Alectinib 150 mg | Kapsul | PT. Menarini Indria Laboratories | EXCELLA GMBH & CO. KG, GERMANY | Indikasi Posologi Baru | 100 HK | 02/09/2024 | Ratna | Evaluasi efikasi keamanan | SPP Disetujui | DKI2157510201A1 | 23/12/2021 | 23/12/2026 | 03/04/2025 | ||
75 | 75 | XIGDUO XR | EREG10042212400083, EREG10042212400116, EREG10042212400117, EREG10042212400118 | Dapagluflozin Metformin 5/500 mg; 5/1000 mg; 10/500 mg; 10/1000 mg | Tablet Salut Selaput | PT. Astrazeneca Indonesia | AstrazeneCA PHARMACEUTICALS LP, USA | Indikasi Posologi Baru | 300 HK | 03/09/2024 | Ghina | Evaluasi efikasi keamanan | SPP Disetujui | DKI1827900217A1 | 18/06/2023 | 18/06/2028 | 24/03/2025 | ||
76 | 76 | EVRYSDI | EREG10043712200277 | Risdiplam 60 mg | Sirup kering | PT. Menarini Indria Laboratories | HOFFMANN-LA ROCHE LTD, BASEL, Switzerland | Posologi baru | 300 HK | 04/09/2024 | Rina | SPP Disetujui | SPP Disetujui | DKI2157511138A1 | 16/08/2024 | 20/12/2026 | 06/09/2024 | ||
77 | 77 | URECE | EREG17180812400009-11 | Tablet | PT. EISAI INDONESIA | FUJI YAKUHIN CO., LTD., TOYAMA PLANT, JAPAN | 300 HK | 05/09/2024 | Ghina | Evaluasi efikasi keamanan | Evaluasi efikasi keamanan | ||||||||
78 | 78 | ZENON | EREG10002212400288-89 | Rosuvastatin calcium 10.4 mg dan 20.8 mg ~ Rosuvastatin 10 mg dan 20 mg / Ezetimibe 10 mg | Tablet Salut Selaput | PT. Kalventis Sinergi Farma, Jakarta | Sanofi Ilac San. Ve Tic. A.S., Luleburgaz, Turkey | Indikasi Posologi Baru | 300 HK | 09/09/2024 | Anin | Evaluasi efikasi keamanan | Evaluasi efikasi keamanan | ||||||
79 | 79 | TAMSOLI | EREG10019112200423 | Tamsulosin hydrochloride 0.4 mg + solifenacin succinate 6 mg | Tablet Salut Selaput Pelepasan Lambat | PT. PRATAPA NIRMALA | SYNTHON HISPANIA, S.L, Barcelona | Kombinasi Baru | 300 HK | 11/09/2024 | Ghina | Evaluasi mutu dan penandaan | Evaluasi mutu dan penandaan | ||||||
80 | 80 | Azilect | EREG10019012200118 | Rasagiline mesilate 1,56 mg setara dengan Rasagiline base 1 mg | Tablet | PT. Actavis Indonesia | Pliva Hrvatska D.O.O, Prilaz Baruna Filipovica, Zagreb, Republic of Croatia | zat aktif baru | 300 HK | 25/09/2024 | Ghina | NIE disetujui | NIE Disetujui | DKI2468500110A1 | 17/10/2024 | 17/10/2024 | |||
81 | 81 | Nixaven | EREG10010212100357-358 | Cefixime 100 mg; 200 mg | ORALLY DISINTEGRATING TABLET | PT Novell Pharmaceutical Laboratories | ETERCON PHARMA, DEMAK | bentuk sediaan baru | 300 HK | Noviana | Staff Penomoran - Penomoran NIE | Staff Penomoran - Penomoran NIE | |||||||
82 | 82 | Daylax | EREG10025312300003 | Macrogol 3350 17 g | Serbuk | PT MEIJI INDONESIAN PHARMACEUTICAL INDUSTRIES | MEIJI INDONESIAN PHARMACEUTICAL INDUSTRIES | Indikasi Posologi Baru | 300 HK | Noviana | NIE Disetujui | DKL2015305423A1 | 21/10/2020 | 21/10/2025 | 02/10/2024 | ||||
83 | 83 | Veoza | EREG10021712400175 | Fezolinetant 45.0 mg ~ Fezolinetant 45.0 mg | Tablet Salut Selaput | PT COMBIPHAR | STELLAS PHARMA INC. YAIZU TECHNOLOGY CENTER, JAPAN | zat aktif baru | 120 HK | 08/10/2024 | Rina | Evaluator - Evaluasi Pengiriman Berkas Khasiat & Keamanan | NIE Disetujui | DKI2520100717A1 | 04/03/2025 | 04/03/2030 | |||
84 | 84 | Actapax-NAB | EREG10019012200047 | Paclitaxel 100 mg | Serbuk Injeksi Liofilisasi | PT. ACTAVIS INDONESIA | PHARMACHEMIE B.V, HAARLEM, Netherlands | bentuk sediaan baru, indikasi dan posologi baru | 300 HK | 08/10/2024 | Rina | Mutu Penandaan | Evaluasi mutu dan penandaan | ||||||
85 | 85 | Pacliall | EREG10006112100138 | Paclitaxel 100 mg | Serbuk Injeksi Liofilisasi | PT. SOHO INDUSTRI PHARMASI | ANACEA BIOTEC PHARMA LTD.,, BADDI, India | bentuk sediaan baru, indikasi dan posologi baru | 300 HK | 08/10/2024 | Rina | Evaluasi mutu dan penandaan | |||||||
86 | 86 | Yurpeak | EREG10019312200172-177 | Tirzepatide 2.5 mg; 5 mg; 7.5 mg; 10 mg;12.5 mg; 15 mg | Injeksi | PT. PYRIDAM FARMA TBK | ELI LILLY AND COMPANY, INDIANAPOLIS, United States of America | zat aktif baru | 300 HK | 08/10/2024 | Rina | Evaluasi mutu dan penandaan | Evaluasi mutu dan penandaan | ||||||
87 | 87 | Xpovio | EREG10032312300003-07 | Selinexor 20.00 mg | Tablet Salut Selaput | PT. MECOSIN INDONESIA | CATALENT CTS, LLC, KANSAS, United States of America | zat aktif baru | 300 HK | 08/10/2024 | Rina | Evaluasi mutu dan penandaan | Evaluasi mutu dan penandaan | ||||||
88 | 88 | Brilinta | EREG10042212400211-212 | Ticagrelor 90 mg | Tablet Salut Selaput Orodispersibel Tablet | PT. AStrazeneca Indonesia | ASTRAZENECA AB Sodertalje, Sweden, | Posologi Baru | 120 HK | 09/10/2024 | Sofi | Evaluasi efikasi keamanan | Evaluasi efikasi keamanan | DKI2351304481A1 | 31/03/2023 | 31/03/2028 | 27/05/2025 | ||
89 | 89 | Byfavo | EREG10026012400437-438 | Remimazolam Besylate 28.22 mg ~ Remimazolam 20.75 mg Remimazolam Besylate 69.37 mg ~ Remimazolam 51.0 mg | Serbuk Injeksi Liofilisasi | PT. Dexa Medica - Indonesia | Hana Pharm Co., Ltd. 13-39, Jeyakdanji-Ro,Hyangnam-Eup, Gyeonggi-Do, Hwaseong-Si, Republic Of Korea | zat aktif baru | 300 HK | 10/10/2024 | Sofi | Evaluasi efikasi keamanan | NIE Disetujui | DPI2615000244A1 | 18/03/2026 | 18/03/2031 | |||
90 | 90 | Ledaga | EREG10019312400108 | Chlormethine hydrochloride 0,0002 g ~ Chlormethine 160 mcg | Gel | PT PYRIDAM FARMA TBK | UNIVERSITY OF IOWA PHARMACEUTICALS, USA | zat aktif baru | 300 HK | 16/10/2024 | Sofi | Evaluasi efikasi keamanan | Evaluasi efikasi keamanan | ||||||
91 | 91 | Flodeg | EREG10040912400156 | 2-Deoxy-2-(18F) Fluoro-D-Glucose ≤ 12765 MBq (≤ 345 mCi) | Injeksi | PT BIO FARMA | BIO FARMA | zat aktif baru | 100 HK | 21/10/2024 | Noviana | Evaluasi efikasi keamanan | Evaluasi efikasi keamanan | DKL2502908443A1 | 01/05/2025 | 01/05/2030 | |||
93 | 93 | SYMVENU | EREG10002812400075 (Symvenu 1.5 mg) EREG10002812400076 (Symvenu 3.0 mg) EREG10002812400077 (Symvenu 4.5 mg) EREG10002812400078 (Symvenu 6.0 mg) | Cariprazine hydrochloride 1,635 mg setara dengan Cariprazine 1,5 mg; Cariprazine hydrochloride 3,270 mg setara dengan Cariprazine 3,0 mg; Cariprazine hydrochloride 4,905 mg setara dengan Cariprazine 4,5 mg; Cariprazine hydrochloride 6,54 mg setara dengan Cariprazine 6,0 mg | Kapsul | PT. Mitsubishi Tanabe Pharma, Indonesia | Gedeon Richter PLC., Budapest, Hungary | Indikasi Posologi Baru | 300 HK | Sofira | evaluasi khasiat keamanan | evaluasi khasiat keamanan | |||||||
94 | 94 | LEVAMLODIPINE / ESAMLO | EREG10019112400463 (LEVALMODIPINE MALEAT 5) EREG10019112400464 (LEVALMODIPINE MALEAT 2,5) EREG10019112400465(ESAMLO 5) EREG10019112400466 (ESAMLO 2,5) | Levamodipine maleat 2.5 dan 5 mg | Tablet | PT. Pratapa NIrmala, Tanggerang | PT. Pratapa NIrmala, Tanggerang | zat aktif baru | 300 HK | sofira | evaluasi khasiat keamanan | evaluasi khasiat keamanan | |||||||
95 | 95 | Labeta | EREG1002210102200212 | Labetalol hydrochloride 5 mg/ml | Injeksi | PT. Kalbe Farma | PT. Dankos Farma | zat aktif baru | 300 HK | 01/12/2024 | sofira/rina | evaluasi mutu dan penandaan | evaluasi mutu dan penandaan | ||||||
96 | 96 | Gralise | EREG10001512300060-61 | Gabapentin 300 mg; 600 mg | Tablet Pelepasan Lambat | PT. Imedco Djaja | Norwich Pharmaceutical Inc, USA | bentuk sediaan baru; indikasi baru | 300 HK | 20/12/2024 | Ghina | evaluasi mutu dan penandaan | evaluasi mutu dan penandaan | ||||||
97 | 97 | Copaxone | EREG10019012200048 | Glatiramer acetate 40 mg/ml | Solution for injection | PT Actavis Indonesia | Norton Healthcare Limited T/A Ivax Pharmaceuticals UK | 300 HK | 27/12/2024 | Ghina | Draft NIE | NIE | DKI2462300243A1 | 30/12/2024 | 30/12/2024 | ||||
98 | 98 | EPLERENONE / EPLERON | EREG10019112300045-48 | Eplerenone 25 mg ; 50 mg | Tablet salut selaput | PT. Prapa nirmala | Pratapa Nirmala | zat aktif baru | 300 HK | Noviana | NIE | NIE | GKL2431551617A1-B1 DKL2431551517A1-B1 | 30/12/2024 | 30/12/2029 | ||||
99 | 99 | PANADOL EXTRA | Paracetamol 500 mg; Caffeine 65 mg | Kaplet | STERLING PRODUCTS INDONESIA | STERLING PRODUCTS INDONESIA, JAKARTA | indikasi posologi baru | 300 HK | Anindya | SPP | SPP | DBL9424502004A1 | 02/05/2024 | 02/05/2029 | 02/02/2025 | ||||
100 | 100 | CALQUENCE | EREG10042212300193 | Acalabrutinib maleate 129 mg ~ Acalabrutinib 100 mg | TABLET SALUT SELAPUT | PT. ASTRAZENECA INDONESIA, BEKASI | ASTRAZENECA AB, SODERTALJE, SWEDEN | Dus, 7 blister @ 8 tablet salut selaput | 300 HK | Ghina | NIE | NIE | DKI2551304917A1 | 07/01/2025 | 07/01/2030 | ||||
101 | 101 | CLOBAZAM | EREG10002212400374 | Clobazam 10mg | Tablet | PT. Kalventis Sinergi Farma | PT. Kalventis Sinergi Farma | Nama Generik | 300HK | 13/02/2025 | Anindya | nie | nie | GPL2521208710A1 | 22/08/2025 | 22/08/2030 |