You are here:
Name SMC ID No Manufacturer Status Sub. Type
 
lopinavir 200 mg, ritonavir 50 mg tablet (Kaletra) 326/06 Abbott Laboratories Limited Accepted Abbreviated Submission
ombitasvir / paritaprevir ritonavir (Viekirax) and dasabuvir (Exviera) 1051/15 AbbVie Ltd Accepted Full submission
glecaprevir/pibrentasvir (Maviret) 1278/17 AbbVie Ltd Accepted Full submission
lopinavir/ritonavir (Kaletra) 1302/18 AbbVie Ltd Accepted Abbreviated Submission
dalbavancin (Xydalba) 1105/15 Allergan/Actavis Restricted Full submission
azithromycin (Zedbac) 950/14 Aspire Pharma Ltd Accepted Abbreviated Submission
micafungin (Mycamine) 497/08 Astellas Pharma Ltd Restricted Full submission
fidaxomicin (Dificlir) 791/12 Astellas Pharma Ltd Restricted Full submission
ceftaroline fosamil (Zinforo) 830/12 AstraZeneca UK Ltd Restricted Full submission
isavuconazole (Cresemba) 1129/16 Basilea Pharmaceuticals Ltd Accepted Full submission
ceftobiprole medocaril (Zevtera) 943/14 Basilea Pharmaceuticals Ltd Restricted Resubmission
moxifloxacin (Avelox IV) 650/10 Bayer plc/Bayer Schering Pharma Restricted Full submission
Moxifloxacin (Avelox®) 70/03 Bayer plc/Bayer Schering Pharma Restricted Full submission
tipranavir (Aptivus) 100mg/ml oral solution 602/10 Boehringer Ingelheim Ltd Restricted Abbreviated Submission
tipranavir (Aptivus) 250mg soft capsule 616/10 Boehringer Ingelheim Ltd Restricted Abbreviated Submission
nevirapine (Viramune) 760/12 Boehringer Ingelheim Ltd Accepted Abbreviated Submission
Tipranavir (Aptivus®) 226/05 Boehringer Ingelheim Ltd Not Recommended Full submission
tipranavir, 250 mg capsule (Aptivus) 226/06 Boehringer Ingelheim Ltd Restricted Resubmission
Atazanavir (Reyataz®) 120/04 Bristol-Myers Squibb Pharmaceuticals Ltd Restricted Full submission
atazanavir (Reyataz) 520/08 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Full submission
atazanavir (Reytaz) 656/10 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Abbreviated Submission
entecavir (Baraclude) 747/11 Bristol-Myers Squibb Pharmaceuticals Ltd Not Recommended Full submission
daclatasvir (Daklinza) 1002/14 Bristol-Myers Squibb Pharmaceuticals Ltd Restricted Full submission
entecavir (Baraclude) 1049/15 Bristol-Myers Squibb Pharmaceuticals Ltd Restricted Abbreviated Submission
atazanavir & cobicistat (Evotaz) 1098/15 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Abbreviated Submission
entecavir, 0.5 and 1mg tablets (Baraclude) 320/06 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Full submission
efavirenz / emtricitabine / tenofovir disoproxil fumarate (Atripla) 442/08 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Abbreviated Submission
efavirenz (Sustiva) 1125/15 Bristol-Myers Squibb Pharmaceuticals Ltd / AstraZeneca Accepted Abbreviated Submission
Daptomycin (Cubicin) 248/06 Chiron Biopharmaceuticals Restricted Full submission
telavancin hydrochloride (Vibativ) 1015/14 Clinigen Healthcare Ltd Not Recommended Non submission
tedizolid phosphate (Sivextro) 1080/15 Cubist (UK) Limited Restricted Full submission
rifampicin, isoniazid, pyrazinamide, ethambutol hydrochloride (Voractiv) 876/13 Genus Pharmaceuticals Not Recommended Non submission
Adefovir dipivoxil (Hepsera®) 54/03 Gilead Sciences Ltd Restricted Resubmission
Adefovir dipivoxil (Hepsera®) 54/03 Gilead Sciences Ltd Not Recommended Full submission
tenofovir disoproxil (Viread) 720/11 Gilead Sciences Ltd Accepted Full submission
aztreonam (Cayston) 753/12 Gilead Sciences Ltd Not Recommended Full submission
aztreonam lysine (Cayston) 753/12 Gilead Sciences Ltd Restricted Resubmission
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate (Genvoya) 1142/16 Gilead Sciences Ltd Accepted Full submission
emtricitabine/tenofovir alafenamide (Descovy) 1169/16 Gilead Sciences Ltd Accepted Abbreviated Submission
rilpivirine/emtricitabine/tenofovir alafenamide (Odefsey) 1189/16 Gilead Sciences Ltd Accepted Abbreviated Submission
sofosbuvir/velpatasvir (Epclusa) 1195/16 Gilead Sciences Ltd Restricted Full submission
rilpivirine 25mg, emtricitabine 200mg, tenofovir disoproxil (as fumarate) 245mg tablet (Eviplera®) 951/14 Gilead Sciences Ltd Accepted Full submission
cobicistat (Tybost) 933/13 Gilead Sciences Ltd Not Recommended Non submission
sofosbuvir 400mg tablet (Sovaldi®) 964/14 Gilead Sciences Ltd Accepted Full submission
ledipasvir-sofosbuvir (Harvoni) 1030/15 Gilead Sciences Ltd Restricted Full submission
ledipasvir/sofosbuvir (Harvoni) 1084/15 Gilead Sciences Ltd Restricted Full submission
elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, tenofovir disoproxil (as fumarate) 245mg film coated tablet (Stribild®) 887/13 Gilead Sciences Ltd Accepted Full submission
tenofovir disoproxil (Viread) 900/13 Gilead Sciences Ltd Restricted Abbreviated Submission
tenofovir disoproxil (Viread) 904/13 Gilead Sciences Ltd Restricted Abbreviated Submission
tenofovir disoproxil (Viread) 905/13 Gilead Sciences Ltd Restricted Abbreviated Submission
Emtricitabine 200 mg hard capsules (Emtriva®) 105/04 Gilead Sciences Ltd Accepted Resubmission
Emtricitabine 200mg hard capsules (Emtriva®) 105/04 Gilead Sciences Ltd Not Recommended Full submission
Emtricitabine/tenofovir disoproxil 200 mg / 245 mg tablet (Truvada®) 237/06 Gilead Sciences Ltd Accepted Abbreviated Submission
Tenofovir disoproxil fumarate (Viread®) 03/02 Gilead Sciences Ltd Restricted Full submission
tenofovir (Viread) 479/08 Gilead Sciences Ltd Accepted Full submission
emtricitabine/tenofovir disoproxil (Truvada) 1225/17 Gilead Sciences Ltd Accepted Full submission
tenofovir alafenamide (Vemlidy) 1238/17 Gilead Sciences Ltd Not Recommended Non submission
sofosbuvir/velpatasvir (Epclusa) 1271/17 Gilead Sciences Ltd Restricted Full submission
emtricitabine / tenofovir / rilpivirine (Eviplera) 759/12 Gilead Sciences Ltd Accepted Abbreviated Submission
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil (as fumarate) (Stribild) 1310/18 Gilead Sciences Ltd Not Recommended Non submission
Abacavir/lamivudine combination (Kivexa®) 175/05 GlaxoSmithKline UK Ltd Accepted Abbreviated Submission
fosamprenavir (Telzir) 431/07 GlaxoSmithKline UK Ltd Accepted Abbreviated Submission
fosamprenavir (Telzir) 431/07 GlaxoSmithKline UK Ltd Not Recommended Non submission
lamivudine / zidovudine (Combivir) 569/09 GlaxoSmithKline UK Ltd Accepted Abbreviated Submission
Fosamprenavir 700mg tablets and oral suspension 50mg/ml (Telzir®) 188/05 GlaxoSmithKline UK Ltd Accepted Full submission
Abacavir 300mg tablets (Ziagen®) 174/05 GlaxoSmithKline UK Ltd Accepted Abbreviated Submission
Clarithromycin 125 mg, 187.5 mg, 250 mg granules for oral suspension (ClaroSip®) 217/05 Grünenthal Ltd Not Recommended Abbreviated Submission
doripenem (Doribax) 529/09 Janssen-Cilag Ltd Marketing Authorisation Withdrawn Full submission
doripenem (Doribax) 539/09 Janssen-Cilag Ltd Marketing Authorisation Withdrawn Full submission
darunavir (Prezista) 707/11 Janssen-Cilag Ltd Accepted Full submission
telaprevir (Incivo) Exp 742/11 Janssen-Cilag Ltd Accepted Full submission
telaprevir (Incivo) Naive 743/11 Janssen-Cilag Ltd Accepted Full submission
darunavir (Prezista) 861/13 Janssen-Cilag Ltd Restricted Abbreviated Submission
rilpivirine hydrochloride (Edurant) 1168/16 Janssen-Cilag Ltd Accepted Abbreviated Submission
darunavir (Prezista) 948/14 Janssen-Cilag Ltd Restricted Abbreviated Submission
simeprevir (Olysio) 988/14 Janssen-Cilag Ltd Accepted Full submission
darunavir (Prezista) 1069/15 Janssen-Cilag Ltd Restricted Abbreviated Submission
darunavir cobicistat (Rezolsta) 1081/15 Janssen-Cilag Ltd Accepted Full submission
etravirine (Intelence) 901/13 Janssen-Cilag Ltd Restricted Abbreviated Submission
darunavir/cobicistat/emtricitabine/tenofovir alafenamide fumarate (Symtuza) 1290/18 Janssen-Cilag Ltd Accepted Abbreviated Submission
caspofungin (Cancidas) 147/04 MSD Restricted Full submission
caspofungin acetate (Caspofungin) 74/03 MSD Restricted Full submission
caspofungin acetate (Caspofungin) 30/03 MSD Not Recommended Full submission
caspofungin (Cancidas) 551/09 MSD Accepted Abbreviated Submission
caspofungin (Cancidas) 552/09 MSD Restricted Abbreviated Submission
raltegravir (Isentress) 613/10 MSD Restricted Full submission
boceprevir (Victrelis) Experienced Patients 722/11 MSD Accepted Full submission
boceprevir (Victrelis) Naive Patients 723/11 MSD Accepted Full submission
ceftolozane-tazobactam (Zerbaxa) 1146/16 MSD Not Recommended Full submission
elbasvir-grazoprevir (Zepatier) 1203/17 MSD Accepted Full submission
posaconazole (Noxafil) 999/14 MSD Restricted Abbreviated Submission
posaconazole (Noxafil) 1067/15 MSD Accepted Abbreviated Submission
raltegravir (Isentress) 1102/15 MSD Restricted Abbreviated Submission
raltegravir (Isentress) 1113/15 MSD Restricted Abbreviated Submission
raltegravir (Isentress) 902/13 MSD Restricted Abbreviated Submission
ertapenem (Invanz) 134/04 MSD Restricted Full submission
ertapenem sodium infusion (Invanz) Paediatric 291/06 MSD Restricted Abbreviated Submission
ertapenem 1g vial of powder for solution for intravenous infusion (Invanz) 335/06 MSD Restricted Full submission
ertapenem (Invanz) 404/07 MSD Restricted Full submission
raltegravir (Isentress) 461/08 MSD Restricted Full submission
raltegravir (Isentress) 1280/17 MSD Restricted Abbreviated Submission
daptomycin (Cubicin) 1309/18 MSD Not Recommended Non submission
fosfomycin (Fomicyt) 1033/15 Nordic Pharma UK Restricted Abbreviated Submission
rifaximin (Xifaxanta) 808/12 Norgine Ltd Not Recommended Non submission
rifaximin (Targaxan) 893/13 Norgine Ltd Accepted Full submission
tobramycin inhalation powder 28mg (TOBI Podhaler) 783/12 Novartis Pharmaceuticals UK Ltd Superseded Full submission
daptomycin (Cubicin) 1141/16 Novartis Pharmaceuticals UK Ltd Not Recommended Non submission
daptomycin 500 mg powder for intravenous infusion (Cubicin) 338/06 Novartis Pharmaceuticals UK Ltd Restricted Abbreviated Submission
telbivudine (Sebivo) 438/08 Novartis Pharmaceuticals UK Ltd Accepted Full submission
daptomycin (Cubicin) 449/08 Novartis Pharmaceuticals UK Ltd Restricted Full submission
ciprofloxacin 3mg/mL + dexamethasone 1mg/mL ear drops (Cilodex) 1256/17 Novartis Pharmaceuticals UK Ltd Restricted Abbreviated Submission
voriconazole (Vfend) 1014/14 Pfizer Ltd Not Recommended Non submission
tigecycline (Tygacil) 1101/15 Pfizer Ltd Not Recommended Non submission
Voriconazole (VFEND®) 25/02 Pfizer Ltd Restricted Full submission
Voriconazole (VFEND®) 142/04 Pfizer Ltd Restricted Abbreviated Submission
Voriconazole 50mg and 200mg tablets, 40mg/ml oral suspension, and 200mg vials (Vfend®) for infusion 194/05 Pfizer Ltd Restricted Full submission
maraviroc (Celsentri) 458/08 Pfizer Ltd Not Recommended Full submission
maraviroc (Celsentri) 458/08 Pfizer Ltd Not Recommended Resubmission
anidulafungin (Ecalta) 465/08 Pfizer Ltd Not Recommended Full submission
anidulafungin (Ecalta) 465/08 Pfizer Ltd Restricted Resubmission
ceftaroline fosamil (Zinforo) 1306/18 Pfizer Ltd Not Recommended Non submission
ceftazidime avibactam (Zavicefta) 1307/18 Pfizer Ltd Not Recommended Non 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
valganciclovir (Valcyte) 586/09 Roche Restricted Abbreviated Submission
valganciclovir (Valcyle) 587/09 Roche Restricted Abbreviated Submission
valganciclovir (Valcyte) 662/10 Roche Restricted Full submission
oseltamivir (Tamiflu) 1127/16 Roche Accepted Abbreviated Submission
Enfuvirtide (Fuzeon®) 56/03 Roche Restricted Full submission
Valganciclovir (Valcyte) 21/02 Roche Restricted Full submission
Valganciclovir (Valcyte) 62/03 Roche Restricted Abbreviated Submission
Interferon-alpha-2b/ Ribavarin (Viraferon/ Rebetol) 258/06 Schering-Plough Ltd Accepted Full submission
Posaconazole 40mg/ml Oral Suspension (Noxafil) 256/06 Schering-Plough Ltd Accepted Full submission
posaconazole 40mg/ml oral suspension (Noxafil) 379/07 Schering-Plough Ltd Restricted Full submission
cefuroxime sodium (Aprokam) 932/13 Spectrum Thea Pharmaceuticals Limited Not Recommended Non submission
etravirine (Intelence) 530/09 Tibotec (Janssen-Cilag Ltd) Not Recommended Full submission
etravirine (Intelence) 530/09 Tibotec (Janssen-Cilag Ltd) Accepted Resubmission
darunavir (Prezista) 566/09 Tibotec (Janssen-Cilag Ltd) Accepted Full submission
darunavir (Prezista) 604/10 Tibotec (Janssen-Cilag Ltd) Accepted Abbreviated Submission
rilpivirine (Edurant) 758/12 Tibotec (Janssen-Cilag Ltd) Accepted Full submission
darunavir 300mg tablets (Prezista) 378/07 Tibotec (Janssen-Cilag Ltd) Accepted Full submission
tobramycin (Bramitob) 314/06 Trinity-Chiesi Pharmaceuticals Ltd Accepted Abbreviated Submission
dolutegravir (Tivicay) 961/14 ViiV Healthcare/GSK Accepted Full submission
dolutegravir, abacavir, lamivudine (Triumeq) 1009/14 ViiV Healthcare/GSK Accepted Abbreviated Submission
dolutegravir (Tivicay) 1253/17 ViiV Healthcare/GSK Accepted Abbreviated Submission
maraviroc (Celsentri) 1282/17 ViiV Healthcare/GSK Not Recommended Non submission
Tigecycline 50mg vial of powder tigecycline for intravenous infusion (Tygacil®) 277/06 Wyeth Pharmaceuticals Restricted Full submission
tigecycline 50mg vial of powder tigecycline for intravenous infusion (Tygacil) 276/06 Wyeth Pharmaceuticals Restricted Full submission

Back