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Janssen-Cilag Ltd

Name SMC ID No Status Sub. Type
 
abiraterone (Zytiga) 764/12 Not Recommended Full submission
abiraterone (Zytiga) 764/12 Restricted Resubmission
abiraterone (Zytiga) 873/13 Not Recommended Non submission
abiraterone (Zytiga) 873/13 Accepted IRP
abiraterone (Zytiga) 873/13 Not Recommended Full submission
bortezomib (Velcade) 822/12 Accepted Abbreviated Submission
bortezomib (Velcade) 1075/15 Accepted Full submission
bortezomib (Velcade) 927/13 Restricted Full submission
canagliflozin (Invokana®) 963/14 Superseded Full submission
canagliflozin plus metformin (Vokanamet) 1019/14 Restricted Abbreviated Submission
daratumumab (Darzalex) 1205/17 Not Recommended Full submission
daratumumab (Darzalex) 1205/17 Restricted Resubmission
darunavir (Prezista) 566/09 Accepted Full submission
darunavir (Prezista) 604/10 Accepted Abbreviated Submission
darunavir (Prezista) 707/11 Accepted Full submission
darunavir (Prezista) 861/13 Restricted Abbreviated Submission
darunavir (Prezista) 948/14 Restricted Abbreviated Submission
darunavir (Prezista) 1069/15 Restricted Abbreviated Submission
darunavir 300mg tablets (Prezista) 378/07 Accepted Full submission
darunavir cobicistat (Rezolsta) 1081/15 Accepted Full submission
darunavir/cobicistat/emtricitabine/tenofovir alafenamide fumarate (Symtuza) 1290/18 Accepted Abbreviated Submission
decitabine (Dacogen) 846/12 Not Recommended Non submission
doripenem (Doribax) 529/09 Marketing Authorisation Withdrawn Full submission
doripenem (Doribax) 539/09 Marketing Authorisation Withdrawn Full submission
etravirine (Intelence) 530/09 Not Recommended Full submission
etravirine (Intelence) 530/09 Accepted Resubmission
etravirine (Intelence) 901/13 Restricted Abbreviated Submission
Fentanyl transdermal (Durogesic®) 24/02 Restricted Full submission
ibrutinib (Imbruvica) 1151/16 Restricted Resubmission
ibrutinib (Imbruvica) 1258/17 Not Recommended Non submission
ibrutinib (Imbruvica) 1289/17 Not Recommended Non submission
ibrutinib (Imbruvica) CLL 1151/16 Restricted Full submission
ibrutinib (Imbruvica) MCL 1150/16 Accepted Full submission
Methylphenidate OROS (Concerta®) 04/02 Superseded Full submission
Norelgestomic ethinyloestradiol (EVRA®) 48/03 Restricted Full submission
paliperidone (INVEGA) 702/11 Not Recommended Non submission
paliperidone (palmitate 3-monthly) (Trevicta) 1181/16 Accepted Abbreviated Submission
paliperidone palmitate (Xeplion) 713/11 Not Recommended Full submission
paliperidone palmitate (Xeplion) 713/11 Accepted Resubmission
paliperidone prolonged-release tablets (INVEGA) 453/08 Not Recommended Full submission
Rabeprazole (Pariet®) 118/04 Accepted Full submission
rilpivirine (Edurant) 758/12 Accepted Full submission
rilpivirine hydrochloride (Edurant) 1168/16 Accepted Abbreviated Submission
Risperidone (Risperdal Consta®) 22/02 Restricted Full submission
Risperidone (Risperdal®) 113/04 Accepted Full submission
risperidone 3mg 4mg orodispersible tablets (Risperdal Quicklet) 403/07 Restricted Abbreviated Submission
Risperidone orodispersible tablets (Risperdal Quicklet®) 41/03 Restricted Full submission
simeprevir (Olysio) 988/14 Accepted Full submission
telaprevir (Incivo) Exp 742/11 Accepted Full submission
telaprevir (Incivo) Naive 743/11 Accepted Full submission
Topiramate (Topamax) 75/03 Restricted Full submission
topiramate 25, 50mg tablets, 25, 50mg sprinkle capsules (Topamax) 297/06 Restricted Full submission
Tramadol 37.5mg/paracetamol 325mg tablet (Tramacet®) 236/06 Not Recommended Full submission
transdermal fentanyl (Durogesic D Trans 12mcg/hr) 250/06 Restricted Abbreviated Submission
Transdermal fentanyl (Durogesic D Trans®) Patches 189/05 Restricted Full submission
ustekinumab (Stelara) 572/09 Restricted Full submission
ustekinumab (Stelara) 944/14 Accepted Full submission
ustekinumab (Stelara) 1250/17 Accepted Full submission
ustekinumab (Stelara) 1115/15 Superseded Abbreviated Submission

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