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Category: 5.1 Antibacterial drugs

Name SMC ID No Manufacturer Status Sub. Type
 
azithromycin (Zedbac) 950/14 Aspire Pharma Ltd Accepted Abbreviated Submission
aztreonam lysine (Cayston) 753/12 Gilead Sciences Ltd Restricted Resubmission
ceftaroline fosamil (Zinforo) 830/12 AstraZeneca UK Ltd Restricted Full submission
ceftobiprole medocaril (Zevtera) 943/14 Basilea Pharmaceuticals Ltd Restricted Resubmission
ceftolozane-tazobactam (Zerbaxa) 1146/16 MSD Not Recommended Full submission
cefuroxime sodium (Aprokam) 932/13 Spectrum Thea Pharmaceuticals Limited Not Recommended Non submission
dalbavancin (Xydalba) 1105/15 Allergan/Actavis Restricted Full submission
daptomycin (Cubicin) 1141/16 Novartis Pharmaceuticals UK Ltd Not Recommended Non submission
fidaxomicin (Dificlir) 791/12 Astellas Pharma Ltd Restricted Full submission
fosfomycin (Fomicyt) 1033/15 Nordic Pharma UK Restricted Abbreviated Submission
fosfomycin trometamol granules for oral solution (equivalent to 3g fosfomycin) (Monuril) 1163/16 Profile Pharma Ltd Accepted Abbreviated Submission
levofloxacin (Quinsair) 1162/16 Raptor Pharmaceuticals Restricted Full submission
moxifloxacin (Avelox IV) 650/10 Bayer plc/Bayer Schering Pharma Restricted Full submission
rifampicin, isoniazid, pyrazinamide, ethambutol hydrochloride (Voractiv) 876/13 Genus Pharmaceuticals Not Recommended Non submission
rifaximin (Targaxan) 893/13 Norgine Ltd Accepted Full submission
rifaximin (Xifaxanta) 808/12 Norgine Ltd Not Recommended Non submission
tedizolid phosphate (Sivextro) 1080/15 Cubist (UK) Limited Restricted Full submission
tigecycline (Tygacil) 1101/15 Pfizer Ltd Not Recommended Non submission
tobramycin inhalation powder 28mg (TOBI Podhaler) 783/12 Novartis Pharmaceuticals UK Ltd Superseded Full submission

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