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Forthcoming Submissions:

PACE medicines

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 7/08/2017
carfilzomib (Kyprolis) Amgen Ltd Full submission 3/04/2017 4/07/2017 7/08/2017
daratumumab (Darzalex) Janssen-Cilag Ltd Resubmission 31/07/2017 Q3 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) for Hodgkin lymphoma Bristol-Myers Squibb Pharmaceuticals Ltd Full submission 3/04/2017 6/06/2017 10/07/2017
nivolumab (Opdivo) SCCHN Bristol-Myers Squibb Pharmaceuticals Ltd Full submission 5/06/2017 1/08/2017 11/09/2017
olaratumab (Lartruvo) Eli Lilly and Company Ltd Full submission 31/07/2017 Q3 2017 Q4 2017
pegvisomant (Somavert) Pfizer Ltd Resubmission 31/07/2017 Q3 2017 Q4 2017
pembrolizumab (Keytruda) - 1st Line NSCLC MSD Full submission 3/04/2017 6/06/2017 10/07/2017
selexipag (Uptravi) Actelion Pharmaceuticals UK Ltd Full submission 6/03/2017 6/06/2017 10/07/2017
stiripentol (Diacomit) BIOCODEX Resubmission 1/05/2017 1/08/2017 11/09/2017
venetoclax (Venclyxto) AbbVie Ltd Full submission 1/05/2017 4/07/2017 7/08/2017

Non-PACE medicines

Name Manufacturer Submission Type Patient Group Submission Deadline SMC Meeting Date Advice Due
ustekinumab (Stelara) Janssen-Cilag Ltd Full submission 1/05/2017 6/06/2017 10/07/2017
5-aminolevulinic acid hydrochloride (Ameluz) Biofrontera Bioscience GmbH Full submission 5/06/2017 4/07/2017 7/08/2017
aprepitant (Emend) MSD Abbreviated Submission N/A 6/06/2017 10/07/2017
aviptadil/phentolamine mesilate (Invicorp) Evolan Pharma AB Full submission TBC TBC TBC
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 TBC TBC TBC
carbetocin (Pabal) Ferring Pharmaceuticals Ltd Full submission TBC TBC TBC
ciprofloxacin/dexamethasone (Cilodex) Novartis Pharmaceuticals UK Ltd Abbreviated Submission N/A 6/06/2017 10/07/2017
desmopressin oral lyophilisate (Noqdirna) Ferring Pharmaceuticals Ltd Resubmission 5/06/2017 4/07/2017 7/08/2017
dolutegravir (Tivicay) ViiV Healthcare/GSK Abbreviated Submission N/A 6/06/2017 10/07/2017
glycopyrronium bromide (Sialanar) Proveca Limited Abbreviated Submission N/A 6/06/2017 10/07/2017
midazolam Epistatus Prefilled Syringe (Epistatus PFS) Special Products Ltd Abbreviated Submission TBC TBC TBC
reslizumab (Cinqaero) Teva UK Limited Resubmission 3/07/2017 1/08/2017 11/09/2017
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
saxagliptin - dapagliflozin (Qtern) AstraZeneca UK Ltd Abbreviated Submission N/A 6/06/2017 10/07/2017
sofosbuvir/velpatasvir (Epclusa) Gilead Sciences Ltd Full submission 31/07/2017 5/09/2017 9/10/2017

Medicines with advice withheld pending product availability

Name Manufacturer Submission Type Patient Group Submission Deadline SMC Meeting Date Advice Due
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

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