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Atomoxetine (Strattera®) 153/05 Eli Lilly and Company Ltd Superseded Resubmission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

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