Monitoring –Pending 2nd Assessment

MA- Monitoring-Expired

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No. Reference No. Brand Name Generic Name GMP Status Assessment Pathway Application Date Date 1st Assessment Time monitor
13960/2019BPHAMALGAN PARACETAMOL APPLIED FOR GMP ABRIDGED 2019-03-12
Backlog
2024-02-01110
28573/2022ROLINOZ TABLETSCETIRIZINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-14
Backlog
2024-04-2229
3152/2018RECTOFLAM-100MELOXICAM APPLIED FOR GMP ABRIDGED 2018-11-13
Backlog
2023-11-14189
40654/2019VAGIMILTCLINDAMYCIN PHOSPHATE & CLOTRIMAZOLE APPLIED FOR GMP FULL ASSESSMENT 2019-02-27
Backlog
2021-06-211,065
51169/2019GVFLUC SUSPENSIONFLUCONAZOLE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-04-11
Backlog
2021-02-031,203
61286/2019C-TAX T 200CEFIXIME APPLIED FOR GMP RECOGNITION 2019-04-25
Backlog
2022-11-30538
71467/2019RHINAHIST PLUS SYRUP 100MLPROMETHAZINE HCL& CARBOCISTEINE NOT APPLIED FULL ASSESSMENT 2019-05-10
Backlog
2021-06-211,065
81547/2019ADDAVEN FERRIC CHLORIDE/ ZINC CHLORIDE/ MANGANESE CHLORIDE TETRAHYDRATE/ COPPER CHLORIDE DIHYDRATE/ SODIUM SELENITE ANHYDROUS/ POTASSIUM IODIDE/ CHROMIC CHLORIDE HEXAHYDRATE/ SODIUM FLUORIDE/ SODIUM MONHYDRATE DEHYDRATE APPLIED FOR GMP FULL ASSESSMENT 2019-05-20
Backlog
2019-08-271,729
9488/2018POTENCIATOR ARGININE ASPARTATE NOT APPLIED FULL ASSESSMENT 2019-06-19
Backlog
2021-06-211,065
103531/2019 PALONOSETRON HYDROCHLORIDE INJECTION 0.25MG/ML, 5ML VIALPALONOSETRON HYDROCHLORIDE NOT APPLIED RECOGNITION 2019-09-25
Backlog
2024-04-1932
1113971/2018FEVAROL 500/5/5/2/30PARACETAMOL CAFFEINE, PHENYLEPHRINE, CHLORPHENIRAMINE APPLIED FOR GMP ABRIDGED 2018-01-10
Backlog
2023-11-21182
125032/2019PIPTAZONE 4.5PIPERACINE SODIUM UPS AND TAZOBACTAM SODIUM APPLIED FOR GMP FULL ASSESSMENT 2019-12-12
Backlog
2021-08-181,007
134631/2020FLUCOLD SYRUPPARACETAMOL+ CPM NOT APPLIED FULL ASSESSMENT 2020-06-24
Backlog
144623/2020FLUCOLD FORTE + VITAMIN C TABSPARACETAMOL+ CAFFEINE+ PHENYLPHERINE HCL+ TERPINE HYDRATE & ASCORBIC ACID NOT APPLIED FULL ASSESSMENT 2020-06-24
Backlog
0000-00-00
154633/2020FLUCOLD N TABSPARACETAMOL+ CAFFEINE+ PHENYLPHERINE HCL+ CPM NOT APPLIED FULL ASSESSMENT 2020-06-24
Backlog
0000-00-00
164641/2020LONGDAY-SDICLOFENAC POTASSIUM+ PARACETAMOL & SERRATIOPETIDASE NOT APPLIED FULL ASSESSMENT 2020-06-24
Backlog
175476/2020TELMI-40 AMHTELMISARTAN + AMLODIPINE + HYDROCHLOTHIAZIDE APPLIED FOR GMP ABRIDGED 2020-07-22
Backlog
2024-03-2260
185475/2020TELMI-40 CTTELMISARTAN + CHLORTHALIDONE APPLIED FOR GMP ABRIDGED 2020-07-22
Backlog
2024-04-1734
195474/2020TELMI-80 HTELMISARTAN + HYDROCHLOROTHIAZIDE APPLIED FOR GMP ABRIDGED 2020-07-22
Backlog
2023-03-17431
205507/2020ACINET 1000AMOXICILLIN + CLAVULATE POTASSIUM NOT APPLIED ABRIDGED 2020-07-23
Backlog
2024-03-2656
211536/2021HYOMIDE-10HYOSCINE BUTYLBROMIDE APPLIED FOR GMP FULL ASSESSMENT 2021-03-10
Backlog
2022-04-20762
223251/2021FLONIX 500LEVOFLOXACIN NOT APPLIED FULL ASSESSMENT 2021-05-06
Backlog
233516/2021EKAPRIL 2.5RAMPIPRIL NOT APPLIED FULL ASSESSMENT 2021-05-17
Backlog
244347/2021DESLORATOR-5DESLORATADINE APPLIED FOR GMP FULL ASSESSMENT 2021-06-17
Backlog
2021-04-251,122
254798/2021PARACETAMOL B.BRAUN 10MG/ML SOLUTION FOR INFUSIONPARACETAMOL GMP CERTIFICATE AVAILABLE ABRIDGED 2021-06-30
Backlog
2023-08-16279
265614/2021BUCOSINE-GBUTYLBROMIDE NOT APPLIED FULL ASSESSMENT 2021-08-10
Backlog
2022-04-28754
275699/2021NIL WORM TABLETSALBENDAZOLE APPLIED FOR GMP FULL ASSESSMENT 2021-08-13
Backlog
2022-04-20762
285939/2021ABZOLEALBENDAZOLE NOT APPLIED FULL ASSESSMENT 2021-08-20
Backlog
29Via EmailAGOTHIAZIDE-25HYDROCHLOROTHIAZIDE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-09-21
Backlog
2024-04-0249
309088/2021OMEPRAZOLEOMEPRAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2021-11-02
Backlog
2024-04-1833
3110708/2021EMITINO TABLETONDANSETRON APPLIED FOR GMP FULL ASSESSMENT 2021-12-08
Backlog
2024-04-1932
325155/2022DICLOFENAC SODIUMDICLOFENAC SODIUM GMP CERTIFICATE AVAILABLE RECOGNITION 2022-04-21
Backlog
2024-04-0348
3311940/2022SOLIVO 20LEFLUNOMIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-08-23
Backlog
2024-04-1932
3411939/2022SOLIVO 10LEFLUNOMIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-08-23
Backlog
2024-04-2427
3513948/2022VIADIS 100MGSILDENAFIL CITRATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-23
Backlog
2024-03-2755
3613949/2022MEXINE 200MGCIMETIDINE GMP CERTIFICATE AVAILABLE ABRIDGED 2022-09-23
Backlog
2024-04-1932
3715681/2022CHLORAMPHENICOL 250CHLORAMPHENICOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21
Backlog
2024-04-1833
3815713/2022SEAGRA ORAL JELLYCOMBIPACK OF SILDENAFIL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21
Backlog
2024-04-1140
3916177-2022CO-TRIMOXAZOLE SULFAMETHOXAZOLE/ TRIMETHOPRIM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-31
Backlog
2024-04-1932
4016178-2022ICON-100 SULFAMETHOXAZOLE/ TRIMETHOPRIM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-31
Backlog
2024-04-1734
4117103-2022EMITOSS-8ONDANSETRON NOT APPLIED ABRIDGED 2022-11-15
Backlog
2023-09-13251
4217205-2022ABLOL-5TIMOLOL MELEATE BP + BENZALKONIUM CHLORIDE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-16
Backlog
2024-04-1536
4317207-2022CIPROCIN CIPROFLOXACIN HCL USP + BENZALKONIUM HCL B.P GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-16
Backlog
2024-04-1239
443648/2021DOLUTEGRAVIR/LAMIVIDUNE/ TENOFOVIRDOLUTEGRAVIR/LAMIVIDUNE/ TENOFOVIR APPLIED FOR GMP ABRIDGED 2021-05-20
Backlog
2024-04-2229
452073/2023EROSTIN-20EBASTINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-02-14
Backlog
2024-04-2130
462632/2023XIPRO-500CIPROFLOXACIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-02-24
Backlog
2024-04-2526
472625/2023P-ALAXIN DS 20/160DIHYDROARTEMISININ/ PIPERAQUIN PHOSPHATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-02-24
Backlog
2024-04-2427
482883/2023DICARD 100SACUBITRIL, VALSARTAN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01
Backlog
2024-04-2625
493032/2023G-OUT PLUSCOLCHINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-03
Backlog
2024-04-0942
503541/2023VIRALEXINOSINE PRANOBEX GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-13
Backlog
2024-04-1734
51RWANDA-FDA24/HM/0187PROMETIN-25 TABLETS. FULL ASSESSMENT 2024-04-16
52RWANDA-FDA23/HM/0295PIROCAM 20 CAPSULES. ABBRIDGED 2024-03-22
53RWANDA-FDA23/HM/0380Davir creamAciclovir ABBRIDGED 2024-02-29
54RWANDA-FDA23/HM/0276FLUOXIREN CAPSULES 20mgFLUOXETINE ABBRIDGED 2024-02-06
55RWANDA-FDA24/HM/0003BRIVANEXT 100 FULL ASSESSMENT 2024-01-29
56RWANDA-FDA24/HM/0069BRONCATHIOL ENFANTS, solution buvableCarbocisteine FULL ASSESSMENT 2024-01-25
57RWANDA-FDA24/HM/0059BRONCATHIOL EXPECTORANT ADULTES, solution buvableCarbocisteine FULL ASSESSMENT 2024-01-25
58RWANDA-FDA24/HM/0016AvastinBevacizumab RECOGNITION 2024-01-24
59RWANDA-FDA23/HM/0256Darunavir and Ritonavir Tablets 800 mg/100 mgDarunavir and Ritonavir Tablets 800 mg/100 mg FULL ASSESSMENT 2023-10-19
Backlog
60RWANDA-FDA23/HM/0222Lopinavir and Ritonavir Tablets USP 200/50mg FULL ASSESSMENT 2023-10-12
Backlog
61RWANDA-FDA23/HM/0205Dawa-prom syrupPromethazine hydrochloride, FULL ASSESSMENT 2023-06-14
Backlog