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Forthcoming Submissions:

PACE medicines

Name Manufacturer Submission Type Patient Group Submission Deadline SMC Meeting Date Advice Due
daratumumab (Darzalex) Janssen-Cilag Ltd Resubmission 31/07/2017 5/09/2017 9/10/2017
eliglustat (Cerdelga) Sanofi Genzyme Full submission 4/09/2017 Q4 2017 Q4 2017
etelcalcetide (Parsabiv) Amgen Ltd Full submission 5/06/2017 1/08/2017 11/09/2017
mercaptamine (Procysbi) Horizon Pharma Full submission 31/07/2017 Q3 2017 Q4 2017
nivolumab (Opdivo) SCCHN Bristol-Myers Squibb Pharmaceuticals Ltd Full submission 5/06/2017 1/08/2017 11/09/2017
nivolumab (Opdivo) UC Bristol-Myers Squibb Pharmaceuticals Ltd Full submission 2/10/2017 Q4 2017 Q4 2018
obinutuzumab (Gazyvaro) FL Roche Full submission 2/10/2017 Q4 2017 Q4 2018
olaratumab (Lartruvo) Eli Lilly and Company Ltd Full submission 31/07/2017 3/10/2017 13/11/2017
palbociclib (Ibrance) Pfizer Ltd Full submission 4/09/2017 Q4 2017 Q4 2017
pegvisomant (Somavert) Pfizer Ltd Resubmission 31/07/2017 3/10/2017 13/11/2017
pembrolizumab (Keytruda) UC MSD Full submission TBC Q4 2018 Q4 2018
ribociclib (Kisquali) Novartis Pharmaceuticals UK Ltd Full submission TBC TBC TBC
stiripentol (Diacomit) BIOCODEX Resubmission 1/05/2017 1/08/2017 11/09/2017

Non-PACE medicines

Name Manufacturer Submission Type Patient Group Submission Deadline SMC Meeting Date Advice Due
aviptadil/phentolamine mesilate (Invicorp) Evolan Pharma AB Full submission 2/10/2017 7/11/2017 11/12/2017
baricitinib (Olumiant) Eli Lilly and Company Ltd Full submission 3/07/2017 1/08/2017 11/09/2017
beclometasone dipropionate anhydrous + formoterol fumarate dihydrate + glycopyrronium bromide (Trimbow) Chiesi Limited Abbreviated Submission TBC TBC TBC
brodalumab (Kyntheum) LEO Pharmaceuticals Full submission 2/10/2017 7/11/2017 11/12/2017
carbetocin (Pabal) Ferring Pharmaceuticals Ltd Full submission TBC TBC TBC
cladribine (Mavenclad) MSD Full submission TBC TBC TBC
eluxadoline (Truberzi) Allergan Ltd Full submission TBC TBC TBC
glecaprevir / pibrentasvir (Maviret) AbbVie Ltd Full submission 4/09/2017 3/10/2017 13/11/2017
glycopyrronium bromide (Sialanar) Proveca Limited Abbreviated Submission N/A 6/06/2017 10/07/2017
levonorgesterol (Kyleena) Bayer plc/Bayer Schering Pharma Full submission TBC TBC TBC
magnesium glycerophosphate (Neomag) Neoceuticals Ltd Abbreviated Submission TBC 1/08/2017 11/09/2017
midazolam (Epistatus PFS) Integ Health/Special Products Ltd Abbreviated Submission TBC 3/10/2017 13/11/2017
raltegravir (Isentress 600mg) MSD Abbreviated Submission TBC 3/10/2017 13/11/2017
roflumilast (Daxas) AstraZeneca UK Ltd Resubmission 3/07/2017 1/08/2017 11/09/2017
rolapitant (Varuby) Tesaro UK Ltd Full submission 3/07/2017 1/08/2017 11/09/2017
sofosbuvir/velpatasvir (Epclusa) Gilead Sciences Ltd Full submission 31/07/2017 5/09/2017 9/10/2017
tiotropium bromide monohydrate (Spiriva) Boehringer Ingelheim Ltd Abbreviated Submission TBC TBC TBC
tofacitinib citrate (Xeljanz) Pfizer Ltd Full submission TBC TBC TBC
tofactinib (Xeljanz) Pfizer Ltd Full submission TBC TBC TBC

Medicines with advice withheld pending product availability

Name Manufacturer Submission Type Patient Group Submission Deadline SMC Meeting Date Advice Due
afamelanotide (Scenesse) Clinuvel (UK) Ltd Full submission 1/05/2017 4/07/2017 TBC
empaglifozin linagliptin fixed-dose combination (Glyxambi) Boehringer Ingelheim Ltd Abbreviated Submission N/A 4/04/2017 TBC
oritavancin (Orbactiv) The Medicines Company Full submission 2/11/2015 1/12/2015 TBC
reslizumab (Cinqaero) Teva UK Limited Full submission 6/03/2017 4/04/2017 TBC
reslizumab (Cinqaero) Teva UK Limited Resubmission 3/07/2017 1/08/2017 TBC

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