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Name SMC ID No Manufacturer Status Sub. Type
 
Frovatriptan (Migard) 49/03 A Menarini Pharmaceuticals UK Ltd Accepted Resubmission
Frovatriptan (Migard) 49/03 A Menarini Pharmaceuticals UK Ltd Not Recommended Full submission
co-careldopa-levodopa (Duodopa) 316/06 AbbVie Ltd Restricted Resubmission
co-careldopa (Duodopa) 316/06 AbbVie Ltd Not Recommended Resubmission
Clostridium botulinum type A neurotoxin (Botox®) 80/03 Allergan Ltd Not Recommended Resubmission
Clostridium botulinum toxin type A neurotoxin (Botox®) 80/03 Allergan Ltd Not Recommended Full submission
clostridium botulinum type A neurotoxin (Botox) 80/03 Allergan Ltd Accepted Resubmission
botulinum toxin (Vistabel) 680/11 Allergan Ltd Not Recommended Non submission
botulinum toxin type a (Botox) 692/11 Allergan Ltd Not Recommended Full submission
botulinum toxin type a (Botox) 692/11 Allergan Ltd Not Recommended Resubmission
botulinum toxin type A (Botox) 986/14 Allergan Ltd Not Recommended Non submission
botulinum toxin A (Botox) 692/11 Allergan Ltd Restricted Resubmission
fentanyl pectin nasal spray (PecFent) 663/10 Archimedes Pharma UK Ltd Restricted Full submission
quetiapine fumerate (Seroquel XL) 433/07 AstraZeneca UK Ltd Accepted Abbreviated Submission
quetiapine fumerate (Seroquel) 549/09 AstraZeneca UK Ltd Not Recommended Full submission
quetiapine prolonged release and quetiapine immediate release (Seroquel XL and Seroquel IR) 549/09 AstraZeneca UK Ltd Not Recommended Resubmission
quetiapine (Seroquel XL) 744/11 AstraZeneca UK Ltd Not Recommended Non submission
Quetiapine (Seroquel) 104/04 AstraZeneca UK Ltd Accepted Full submission
opicapone (Ongentys) 1281/17 Bial Pharma UK Ltd Not Recommended Non submission
stiripentol (DIACOMIT) 524/08 BIOCODEX Not Recommended Full submission
stiripentol (Diacomit) 524/08 BIOCODEX Accepted Resubmission
pramipexole (Mirapexin) 247/06 Boehringer Ingelheim Ltd Accepted Full submission
pramipexole (Mirapexin) 580/09 Boehringer Ingelheim Ltd Accepted Abbreviated Submission
Aripiprazole (Abilify®) 95/04 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Full submission
Aripiprazole (Abilify®) 187/05 Bristol-Myers Squibb Pharmaceuticals Ltd Restricted Abbreviated Submission
aripiprazole (Abilify) 498/08 Bristol-Myers Squibb Pharmaceuticals Ltd Not Recommended Full submission
aripiprazole (Ablify) 498/09 Bristol-Myers Squibb Pharmaceuticals Ltd Not Recommended Resubmission
aripiprazole IM (Abilify) 522/08 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Abbreviated Submission
aripiprazole tablets, orodisperible tablets and oral solution (Abilify) 630/10 Bristol-Myers Squibb Pharmaceuticals Ltd Restricted Abbreviated Submission
Paracetamol 500mg/50ml intravenous infusion (Perfalgan®) 172/05 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Abbreviated Submission
Paracetamol infusion (Perfalgan®) 137/04 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Full submission
Palonosetron 250 micrograms solution for injection (Aloxi®) 208/05 Cambridge Laboratories Accepted Full submission
Methylphenidate (Equasym XL®) 99/04 Celltech Superseded Full submission
fentanyl buccal tablets (Effentora) 510/08 Cephalon UK Ltd Restricted Full submission
Modafinil (Provigil®) 63/03 Cephalon UK Ltd Withdrawn Resubmission
Modafinil (Provigil®) 63/03 Cephalon UK Ltd Withdrawn Full submission
Modafinil (Provigil®) 63/03 Cephalon UK Ltd Withdrawn Resubmission
Modafinil 100mg and 200mg tablets (Provigil®) 183/05 Cephalon UK Ltd Withdrawn Full submission
palonosetron (Aloxi) 1073/15 Chugai Pharma UK Ltd Accepted Abbreviated Submission
netupitant palonostron (Akynzeo) 1109/15 Chugai Pharma UK Ltd Restricted Full submission
eslicarbazepine acetate (Zebinix) 592/09 Eisai Ltd Not Recommended Full submission
eslicarbazepine (Zebinix) Resubmission 592/09 Eisai Ltd Restricted Resubmission
Zonisamide hard capsules 25 mg, 50 mg, 100 mg (Zonegran®) 216/05 Eisai Ltd Restricted Full submission
rufinamide (Inovelon) 795/12 Eisai Ltd Restricted Abbreviated Submission
zonisamide (Zonegran) 817/12 Eisai Ltd Not Recommended Non submission
perampanel (Fycompa) 819/12 Eisai Ltd Restricted Full submission
perampanel (Fycompa®) 1200/16 Eisai Ltd Not Recommended Non submission
zonisamide (Zonegran) 949/14 Eisai Ltd Restricted Abbreviated Submission
donepezil 5mg & 10mg orodispersible tablets (Aricept Evess) 307/06 Eisai Ltd Superseded Abbreviated Submission
ziconotide 100 micrograms/ml solution for infusion (Prialt) 405/07 Eisai Ltd Not Recommended Full submission
rufinamide 100mg, 200mg and 400mg tablets (Inovelon) 416/07 Eisai Ltd Not Recommended Full submission
rufinamide 100mg, 200mg, 400mg tablets (Inovelon) 416/07 Eisai Ltd Restricted Resubmission
Atomoxetine (Strattera®) 153/05 Eli Lilly and Company Ltd Superseded Resubmission
Atomoxetine (Strattera®) 153/05 Eli Lilly and Company Ltd Not Recommended Full submission
duloxetine (Cymbalta) 514/08 Eli Lilly and Company Ltd Not Recommended Non submission
olanzapine long acting injection (ZypAdhera) 624/10 Eli Lilly and Company Ltd Not Recommended Full submission
atomoxetine (Strattera) 1107/15 Eli Lilly and Company Ltd Restricted Abbreviated Submission
Duloxetine 30mg, 60mg capsules (Cymbalta®) 195/05 Eli Lilly and Company Ltd Restricted Full submission
Olanzapine (Zyprexa) 98/04 Eli Lilly and Company Ltd Accepted Full submission
Olanzapine (Zyprexa®) 44/03 Eli Lilly and Company Ltd Restricted Full submission
Olanzapine (Zyprexa®) 106/04 Eli Lilly and Company Ltd Accepted Full submission
duloxetine 30mg and 60mg capsules (Cymbalta) 285/06 Eli Lilly and Company Ltd Restricted Full submission
extended-release epidural morphine sulfate (Depodur) 528/09 Flynn Pharma Ltd Not Recommended Full submission
extended release morphine sulphate for epidural injection (Depodur) 528/09 Flynn Pharma Ltd Resubmission
botulinum toxin Type A (Azzalure) 679/11 Galderma (UK) Ltd Not Recommended Non submission
ropinirole prolonged release (Requip XL) 491/08 GlaxoSmithKline UK Ltd Accepted Abbreviated Submission
retigabine (Trobalt) 712/11 GlaxoSmithKline UK Ltd Restricted Full submission
ropinirole tablets (Adartrel) 165/05 GlaxoSmithKline UK Ltd Restricted Resubmission
Sumatriptan succinate (Imigran Radis®) 127/04 GlaxoSmithKline UK Ltd Accepted Abbreviated Submission
tapentadol prolonged-release tablets (Palexia SR) 654/10 Grünenthal Ltd Restricted Resubmission
tapentadol film-coated tablets (Palexia) 773/12 Grünenthal Ltd Not Recommended Non submission
sufentanil citrate (Zalviso) 1270/17 Grünenthal Ltd Not Recommended Non submission
clostridium botulinum type A toxin haemagglutinin complex (Dysport®) 353/07 Ipsen Ltd Not Recommended Full submission
clostridium botulinum toxin A (Dysport) 353/07 Ipsen Ltd Restricted Resubmission
transdermal fentanyl (Durogesic D Trans 12mcg/hr) 250/06 Janssen-Cilag Ltd Restricted Abbreviated Submission
paliperidone palmitate (Xeplion) 713/11 Janssen-Cilag Ltd Not Recommended Full submission
paliperidone palmitate (Xeplion) 713/11 Janssen-Cilag Ltd Accepted Resubmission
paliperidone (INVEGA) 702/11 Janssen-Cilag Ltd Not Recommended Non submission
paliperidone (palmitate 3-monthly) (Trevicta) 1181/16 Janssen-Cilag Ltd Accepted Abbreviated Submission
Fentanyl transdermal (Durogesic®) 24/02 Janssen-Cilag Ltd Restricted Full submission
Methylphenidate OROS (Concerta®) 04/02 Janssen-Cilag Ltd Superseded Full submission
Risperidone (Risperdal Consta®) 22/02 Janssen-Cilag Ltd Restricted Full submission
Risperidone (Risperdal®) 113/04 Janssen-Cilag Ltd Accepted Full submission
Risperidone orodispersible tablets (Risperdal Quicklet®) 41/03 Janssen-Cilag Ltd Restricted Full submission
Topiramate (Topamax) 75/03 Janssen-Cilag Ltd Restricted Full submission
Tramadol 37.5mg/paracetamol 325mg tablet (Tramacet®) 236/06 Janssen-Cilag Ltd Not Recommended Full submission
Transdermal fentanyl (Durogesic D Trans®) Patches 189/05 Janssen-Cilag Ltd Restricted Full submission
topiramate 25, 50mg tablets, 25, 50mg sprinkle capsules (Topamax) 297/06 Janssen-Cilag Ltd Restricted Full submission
risperidone 3mg 4mg orodispersible tablets (Risperdal Quicklet) 403/07 Janssen-Cilag Ltd Restricted Abbreviated Submission
paliperidone prolonged-release tablets (INVEGA) 453/08 Janssen-Cilag Ltd Not Recommended Full submission
atomoxetine (Strattera) 909/13 Lilly UK Accepted Full submission
pitolisant (Wakix) 1229/17 Lincoln Medical Limited Not Recommended Non submission
escitalopram (Cipralex) 253/06 Lundbeck Ltd Accepted Full submission
Rasagiline 1mg tablet (Azilect®) 255/06 Lundbeck Ltd Not Recommended Full submission
rasagiline 1mg (Azilect) 255/06 Lundbeck Ltd Not Recommended Resubmission
melatonin 2mg prolonged-release tablets (Circadin) 500/08 Lundbeck Ltd Not Recommended Non submission
asenapine (Sycrest) 762/12 Lundbeck Ltd Not Recommended Full submission
vortioxetine (Brintellix) 1158/16 Lundbeck Ltd Restricted Full submission
nalmefene (Selincro) 917/13 Lundbeck Ltd Accepted Full submission
Escitalopram (Cipralex®) 17/02 Lundbeck Ltd Accepted Resubmission
Escitalopram (Cipralex®) 17/02 Lundbeck Ltd Not Recommended Full submission
Memantine (Ebixa) 57/03 Lundbeck Ltd Superseded Resubmission
Memantine (Ebixa®) 57/03 Lundbeck Ltd Superseded Full submission
Rasagiline 1mg tablet (Azilect®) 243/06 Lundbeck Ltd Not Recommended Full submission
rasagiline 1mg tablet monotherapy (Azilect) 243/06 Lundbeck Ltd Not Recommended Resubmission
escitalopram 5mg, 10mg, 15mg and 20mg tablets and 10mg/ml oral drops (Cipralex) 406/07 Lundbeck Ltd Not Recommended Full submission
escitalopram (Cipralex) 475/08 Lundbeck Ltd Not Recommended Non submission
buprenorphine oral lyophilisate (Espranor) 1245/17 Martindale Pharma Restricted Abbreviated Submission
fentanyl citrate (Breakyl) 947/13 Meda Pharmaceuticals Ltd Not Recommended Non submission
cladribine (Mavenclad) 1300/18 Merck Restricted Full submission
botulinum toxin type a (Bocouture) 695/11 Merz Pharma UK Ltd Not Recommended Non submission
botulinum neurotoxin type A (Xeomin) 464/08 Merz Pharma UK Ltd Accepted Full submission
botulinum toxin type A (Xeomin®) 731/11 Merz Pharma UK Ltd Accepted Abbreviated Submission
aprepitant (Emend) 242/06 MSD Not Recommended Full submission
aprepitant (Emend) 242/06 MSD Not Recommended Resubmission
fosaprepitant (Ivemend) 506/08 MSD Withdrawn Full submission
fosaprepitant dimeglumine (IVEmend 150mg) 678/11 MSD Accepted Abbreviated Submission
aprepitant (Emend) 1241/17 MSD Accepted Full submission
aprepitant (Emend) 1252/17 MSD Accepted Abbreviated Submission
aprepitant (Emend) 132/04 MSD Restricted Full submission
oxycodone (OxyNorm®) 266/06 Napp Pharmaceuticals Ltd Not Recommended Non submission
Buprenorphine (Transtec®) matrix patches 116/04 Napp Pharmaceuticals Ltd Not Recommended Full submission
Buprenorphine transdermal patches (BuTrans) 234/06 Napp Pharmaceuticals Ltd Not Recommended Full submission
buprenorphine transdermal patches (BuTrans) 234/06 Napp Pharmaceuticals Ltd Not Recommended Resubmission
buprenorphine transdermal patch (BuTrans) 234/06 Napp Pharmaceuticals Ltd Not Recommended Resubmission
buprenorphine transdermal patch (BuTrans) 234/06 Napp Pharmaceuticals Ltd Not Recommended Resubmission
oxycodone / naloxone (Targinact) 541/09 Napp Pharmaceuticals Ltd Not Recommended Full submission
oxycodone (Oxynorm) 648/10 Napp Pharmaceuticals Ltd Restricted Full submission
Oxycodone (OxyNorm®) 125/04 Napp Pharmaceuticals Ltd Restricted Full submission
Oxycodone prolonged release tablets 5,10,20,40 and 80mg (OxyContin®) 197/05 Napp Pharmaceuticals Ltd Restricted Full submission
ondansetron (Setofilm) 912/13 Norgine Ltd Restricted Abbreviated Submission
rivastigmine (Exelon) 310/06 Novartis Pharmaceuticals UK Ltd Not Recommended Non submission
rivastigmine 4.6mg/24h and 9.5mg/24h transdermal Patch 414/07 Novartis Pharmaceuticals UK Ltd Superseded Abbreviated Submission
fentanyl (Instanyl) 579/09 Nycomed UK Ltd Restricted Full submission
fentanyl (Instanyl) 750/11 Nycomed UK Ltd Restricted Abbreviated Submission
Mirtazapine (Zispin Soltab®) 66/03 Organon Laboratories Ltd Accepted Abbreviated Submission
Levodopa, carbidopa and entacapone (Stalevo) 85/03 Orion Pharma (UK) Ltd Accepted Abbreviated Submission
aripiprazole (Abilify) 962/14 Otsuka Pharmaceutical Europe Accepted Full submission
aripiprazole (Abilify) 891/13 Otsuka Pharmaceutical Europe Restricted Full submission
pregabalin oral solution (Lyrica) 765/12 Pfizer Ltd Restricted Abbreviated Submission
tafamidis meglumine (Vyndaqel) 877/13 Pfizer Ltd Not Recommended Non submission
Pregabalin, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg and 300mg capsules (Lyrica®) 157/05 Pfizer Ltd Not Recommended Resubmission
Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg and 300mg capsules (Lyrica®) 157/05 Pfizer Ltd Not Recommended Full submission
Pregabalin 25, 50, 75, 100, 150, 200 and 300mg capsules (Lyrica) 157/05 Pfizer Ltd Not Recommended IRP
pregabalin (Lyrica) 157/05 Pfizer Ltd Restricted Resubmission
Pregabalin (Lyrica®) 145/04 Pfizer Ltd Restricted Full submission
Sertraline (Lustral®) 68/03 Pfizer Ltd Not Recommended Full submission
pregabalin (Lyrica) 339/06 Pfizer Ltd Not Recommended Non submission
varenicline 1mg tablets (Champix) 336/06 Pfizer Ltd Accepted Full submission
pregabalin, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg capsules (Lyrica) 389/07 Pfizer Ltd Not Recommended Full submission
fentanyl sublingual (Abstral) 534/09 ProStrakan Restricted Abbreviated Submission
granisetron (Sancuso) 895/13 ProStrakan Accepted Abbreviated Submission
buprenorphine transdermal patch (Butec) 1213/17 Qdem Pharmaceuticals Restricted Full submission
rimonabant 20mg tablet (Acomplia) In Oct 2008 the EMEA recommended temporary suspension of this product. The SMC advice has been withdrawn from the website 341/07 Sanofi-Aventis Advice has been withdrawn from the Website Full submission
buprenorphine/naloxone (Suboxone) 355/07 Schering-Plough Ltd Restricted Full submission
rotigotine 2mg/24 hours, 4mg/24 hours, 6mg/24 hours, 8mg/24 hours transdermal patch (Neupro) 289/06 Schwarz Pharma Ltd Not Recommended Full submission
rotigotine 2mg/24 hours, 4mg/24 hours, 6mg/24 hours, 8mg/24 hours transdermal patch (Neupro) 289/06 Schwarz Pharma Ltd Accepted Resubmission
rotigotine (Neupro) 392/07 Schwarz Pharma Ltd Restricted Full submission
agomelatine (Valdoxan) 564/09 Servier Laboratories Ltd Not Recommended Full submission
agomelatine (Valdoxan) Resubmission 564/09 Servier Laboratories Ltd Not Recommended Resubmission
lisdexamfetamine dimesylate (Elvanse) 863/13 Shire Pharmaceuticals Accepted Full submission
guanfacine hydrochloride (Intuniv) 1123/16 Shire Pharmaceuticals Accepted Full submission
lisdexamfetamine dimesylate (Elvanse Adult) 1079/15 Shire Pharmaceuticals Accepted Full submission
Reminyl XL® 139/04 Shire Pharmaceuticals Superseded Abbreviated Submission
palonosetron (Aloxi) 838/13 Sinclair IS Pharma Accepted Abbreviated Submission
co-careldopa intestinal gel, 20mg/5mg levodopa/cabidopa per ml for continuous intestinal infusion (Duodopa) 316/06 Solvay Healthcare Ltd Not Recommended Full submission
midazolam (Epistatus) 1279/17 Special Products Ltd Accepted Abbreviated Submission
lurasidone (Latuda) 994/14 Sunovion Restricted Full submission
rolapitant (Varuby) 1266/17 Tesaro UK Ltd Restricted Full submission
fentanyl (Ionsys) 1207/16 The Medicines Company Not Recommended Non submission
sodium oxybate 500mg/ml oral solution (Xyrem®) 246/06 UCB Pharma Ltd Not Recommended Full submission
sodium oxybate 500mg/ml oral solution (Xyrem) 246/06 UCB Pharma Ltd Not Recommended Resubmission
lacosamide (Vimpat) 532/09 UCB Pharma Ltd Restricted Full submission
rotigotine (Neupro) 548/09 UCB Pharma Ltd Accepted Full submission
levetiracetam (Keppra) 661/10 UCB Pharma Ltd Restricted Abbreviated Submission
brivaracetam (Briviact) 1160/16 UCB Pharma Ltd Restricted Full submission
levetiracetam (Keppra®) 100mg oral solution 151/04 UCB Pharma Ltd Restricted Abbreviated Submission
levetiracetam (Keppra®) 750 mg tablets 150/04 UCB Pharma Ltd Restricted Abbreviated Submission
levetiracetam 500mg/5ml concentrate for infusion (Keppra) 311/06 UCB Pharma Ltd Accepted Abbreviated Submission
levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) 394/07 UCB Pharma Ltd Not Recommended Full submission
levetiracetam 250 500 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) 394/07 UCB Pharma Ltd Accepted Resubmission
levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) 395/07 UCB Pharma Ltd Not Recommended Full submission
levetiracetam 250 500 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) 395/07 UCB Pharma Ltd Accepted Resubmission
levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) 396/07 UCB Pharma Ltd Not Recommended Full submission
levetiracetam 250 500 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) 396/07 UCB Pharma Ltd Accepted Resubmission
levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) 397/07 UCB Pharma Ltd Not Recommended Full submission
levetiracetam 250 500 750 and 1000mg tablets and levetircetam oral solution 100mg/ml (Keppra) 397/07 UCB Pharma Ltd Restricted Resubmission
lacosamide (Vimpat) 1231/17 UCB Pharma Ltd Not Recommended Non submission
lacosamide (Vimpat) 1301/18 UCB Pharma Ltd Restricted Abbreviated Submission
methylphenidate HCI Prolonged release (Medikinet XL) 388/07 UK Distributer Flynn Pharma Ltd Restricted Abbreviated Submission
caffeine 5mg/ml solution for injection 550/09 Viridian Pharma Ltd (Cardinal Health) Restricted Full submission
midazolam (Buccolam oromucosal solution) 757/12 ViroPharma Ltd Accepted Full submission
diamorphine hydrochloride (Ayendi) 1172/16 Wockhardt UK Ltd Accepted Abbreviated Submission
venlafaxine extended release capsules (Efexor XL) 501/08 Wyeth Pharmaceuticals Not Recommended Non submission

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