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Category: 5.3 Antiviral Drugs

Name SMC ID No Manufacturer Status Sub. Type
 
Abacavir 300mg tablets (Ziagen®) 174/05 GlaxoSmithKline UK Ltd Accepted Abbreviated Submission
Abacavir/lamivudine combination (Kivexa®) 175/05 GlaxoSmithKline UK Ltd Accepted Abbreviated Submission
Adefovir dipivoxil (Hepsera®) 54/03 Gilead Sciences Ltd Restricted Resubmission
Adefovir dipivoxil (Hepsera®) 54/03 Gilead Sciences Ltd Not Recommended Full submission
atazanavir & cobicistat (Evotaz) 1098/15 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Abbreviated Submission
atazanavir (Reyataz) 520/08 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Full submission
Atazanavir (Reyataz®) 120/04 Bristol-Myers Squibb Pharmaceuticals Ltd Restricted Full submission
atazanavir (Reytaz) 656/10 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Abbreviated Submission
aztreonam (Cayston) 753/12 Gilead Sciences Ltd Not Recommended Full submission
boceprevir (Victrelis) Experienced Patients 722/11 MSD Accepted Full submission
boceprevir (Victrelis) Naive Patients 723/11 MSD Accepted Full submission
cobicistat (Tybost) 933/13 Gilead Sciences Ltd Not Recommended Non submission
darunavir (Prezista) 566/09 Tibotec (Janssen-Cilag Ltd) Accepted Full submission
darunavir (Prezista) 604/10 Tibotec (Janssen-Cilag Ltd) Accepted Abbreviated Submission
darunavir (Prezista) 707/11 Janssen-Cilag Ltd Accepted Full submission
darunavir (Prezista) 861/13 Janssen-Cilag Ltd Restricted Abbreviated Submission
darunavir (Prezista) 948/14 Janssen-Cilag Ltd Restricted Abbreviated Submission
darunavir (Prezista) 1069/15 Janssen-Cilag Ltd Restricted Abbreviated Submission
darunavir 300mg tablets (Prezista) 378/07 Tibotec (Janssen-Cilag Ltd) Accepted Full submission
darunavir cobicistat (Rezolsta) 1081/15 Janssen-Cilag Ltd Accepted Full submission
dolutegravir (Tivicay) 961/14 ViiV Healthcare/GSK Accepted Full submission
dolutegravir, abacavir, lamivudine (Triumeq) 1009/14 ViiV Healthcare/GSK Accepted Abbreviated Submission
efavirenz (Sustiva) 1125/15 Bristol-Myers Squibb Pharmaceuticals Ltd / AstraZeneca Accepted Abbreviated Submission
efavirenz / emtricitabine / tenofovir disoproxil fumarate (Atripla) 442/08 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Abbreviated Submission
elbasvir-grazoprevir (Zepatier) 1203/17 MSD Accepted 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
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate (Genvoya) 1142/16 Gilead Sciences Ltd Accepted Full submission
emtricitabine / tenofovir / rilpivirine (Eviplera) 759/12 Gilead Sciences Ltd Accepted 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 alafenamide (Descovy) 1169/16 Gilead Sciences Ltd Accepted Abbreviated Submission
emtricitabine/tenofovir disoproxil (Truvada) 1225/17 Gilead Sciences Ltd Accepted Full submission
Emtricitabine/tenofovir disoproxil 200 mg / 245 mg tablet (Truvada®) 237/06 Gilead Sciences Ltd Accepted Abbreviated Submission
Enfuvirtide (Fuzeon®) 56/03 Roche Restricted Full submission
entecavir (Baraclude) 747/11 Bristol-Myers Squibb Pharmaceuticals Ltd Not Recommended Full submission
entecavir (Baraclude) 1049/15 Bristol-Myers Squibb Pharmaceuticals Ltd Restricted Abbreviated Submission
entecavir, 0.5 and 1mg tablets (Baraclude) 320/06 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Full submission
etravirine (Intelence) 530/09 Tibotec (Janssen-Cilag Ltd) Not Recommended Full submission
etravirine (Intelence) 530/09 Tibotec (Janssen-Cilag Ltd) Accepted Resubmission
etravirine (Intelence) 901/13 Janssen-Cilag Ltd Restricted Abbreviated Submission
fosamprenavir (Telzir) 431/07 GlaxoSmithKline UK Ltd Accepted Abbreviated Submission
fosamprenavir (Telzir) 431/07 GlaxoSmithKline UK Ltd Not Recommended Non submission
Fosamprenavir 700mg tablets and oral suspension 50mg/ml (Telzir®) 188/05 GlaxoSmithKline UK Ltd Accepted Full submission
Interferon-alpha-2b/ Ribavarin (Viraferon/ Rebetol) 258/06 Schering-Plough Ltd Accepted Full submission
lamivudine / zidovudine (Combivir) 569/09 GlaxoSmithKline UK Ltd Accepted Abbreviated Submission
ledipasvir-sofosbuvir (Harvoni) 1030/15 Gilead Sciences Ltd Restricted Full submission
ledipasvir/sofosbuvir (Harvoni) 1084/15 Gilead Sciences Ltd Restricted Full submission
lopinavir 200 mg, ritonavir 50 mg tablet (Kaletra) 326/06 Abbott Laboratories Limited Accepted Abbreviated Submission
maraviroc (Celsentri) 458/08 Pfizer Ltd Not Recommended Full submission
maraviroc (Celsentri) 458/08 Pfizer Ltd Not Recommended Resubmission
nevirapine (Viramune) 760/12 Boehringer Ingelheim Ltd Accepted Abbreviated Submission
ombitasvir / paritaprevir ritonavir (Viekirax) and dasabuvir (Exviera) 1051/15 AbbVie Ltd Accepted Full submission
oseltamivir (Tamiflu) 1127/16 Roche Accepted Abbreviated Submission
raltegravir (Isentress) 613/10 MSD Restricted Full 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
raltegravir (Isentress) 461/08 MSD Restricted Full submission
rilpivirine (Edurant) 758/12 Tibotec (Janssen-Cilag Ltd) Accepted Full submission
rilpivirine 25mg, emtricitabine 200mg, tenofovir disoproxil (as fumarate) 245mg tablet (Eviplera®) 951/14 Gilead Sciences Ltd Accepted Full submission
rilpivirine hydrochloride (Edurant) 1168/16 Janssen-Cilag Ltd Accepted Abbreviated Submission
rilpivirine/emtricitabine/tenofovir alafenamide (Odefsey) 1189/16 Gilead Sciences Ltd Accepted Abbreviated Submission
simeprevir (Olysio) 988/14 Janssen-Cilag Ltd Accepted Full submission
sofosbuvir 400mg tablet (Sovaldi®) 964/14 Gilead Sciences Ltd Accepted Full submission
sofosbuvir/velpatasvir (Epclusa) 1195/16 Gilead Sciences Ltd Restricted Full submission
telbivudine (Sebivo) 438/08 Novartis Pharmaceuticals UK Ltd Accepted Full submission
tenofovir (Viread) 479/08 Gilead Sciences Ltd Accepted Full submission
tenofovir disoproxil (Viread) 720/11 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
Tenofovir disoproxil fumarate (Viread®) 03/02 Gilead Sciences Ltd 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
Tipranavir (Aptivus®) 226/05 Boehringer Ingelheim Ltd Not Recommended Full submission
tipranavir, 250 mg capsule (Aptivus) 226/06 Boehringer Ingelheim Ltd Restricted Resubmission
valganciclovir (Valcyle) 587/09 Roche Restricted Abbreviated Submission
valganciclovir (Valcyte) 586/09 Roche Restricted Abbreviated Submission
valganciclovir (Valcyte) 662/10 Roche Restricted Full submission
Valganciclovir (Valcyte) 21/02 Roche Restricted Full submission
Valganciclovir (Valcyte) 62/03 Roche Restricted Abbreviated Submission

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