Table 1.
Details of the different evaluations leading to approval
| EPAR | Year | Drug | Route | Disease | Manufacturer |
|---|---|---|---|---|---|
| EMEA/H/C/000916 | 2008 | Agomelatine | O | Depressive disorders | Servier |
| a | 2004 | Aripiprazole | O | Schizophrenia | Otsuka |
| EMEA/H/C/000471/II/0015 | 2006 | Aripiprazole | IM | Agitation in patients with schizophrenia and/or bipolar disorders | Otsuka |
| EMEA/H/C/471/II/0039 | 2008 | Aripiprazole | O | Bipolar disorders | Otsuka |
| EMEA/H/C/471/II/0041 | 2008 | Aripiprazole | IM | Agitation in patients with schizophrenia and/or bipolar disorders | Otsuka |
| EMEA/H/C/002755/0000 | 2013 | Aripiprazole | IM | Schizophrenia | Otsuka |
| EMEA/H/C/001177 | 2010 | Asenapine | Sublingual | Bipolar disorders | Organon |
| a | 2006 | Buprenorphine/naloxone | Sublingual | Addictive disorders | Schering-Plough Europe |
| a | 2004 | Duloxetine | O | Depressive disorders | Eli Lilly Nederland BV |
| EMEA/H/C/572/II/27 | 2008 | Duloxetine | O | Anxiety disorders | Eli Lilly Nederland BV |
| EMEA/H/C/572/II/0036 | 2009 | Duloxetine | O | Depressive disorders | Eli Lilly Nederland BV |
| EMEA/H/C/002400 | 2012 | Loxapine | INH | Agitation in patients with schizophrenia and/or bipolar disorders | AlexzaUk |
| EMEA/H/C/002713/0000 | 2014 | Lurasidone | O | Schizophrenia | Takeda Pharma A/S |
| EMEA/H/C/002583/0000 | 2012 | Nalmefene | O | Addictive disorders | Lundbeck |
| EMEA/H/C/000890 | 2008 | Olanzapine | IM | Schizophrenia | Eli Lilly Nederland BV |
| CPMP/0646/96 | 1996 | Olanzapine | O | Schizophrenia | Eli Lilly Nederland BV |
| CPMP/0646/96 | 2003 | Olanzapine | O | Bipolar disorders | Eli Lilly Nederland BV |
| CPMP/0646/96 | 2001 | Olanzapine | IM | Agitation in patients with schizophrenia and/or bipolar disorders | Eli Lilly Nederland BV |
| CPMP/0646/96 | 2002 | Olanzapine | IM | Agitation in patients with schizophrenia and/or bipolar disorders | Eli Lilly Nederland BV |
| a | 2007 | Paliperidone | O | Schizophrenia | Janssen-Cilag |
| EMEA/H/C/000746/II/0023 | 2010 | Paliperidone | O | Schizoaffective disorder | Janssen-Cilag |
| EMEA/H/C/000746/II/0043 | 2015 | Paliperidone | O | Schizoaffective disorder | Janssen-Cilag |
| EMEA/H/C/004066/X/0007/G | 2016 | Paliperidone palmitate long acting injection | IM | Schizophrenia | Janssen-Cilag |
| EMEA/H/C/2105 | 2011 | Paliperidone palmitate long acting injection | IM | Schizophrenia | Janssen-Cilag |
| EMEA/H/C/000546/II/0004 | 2006 | Pregabalin | O | Anxiety disorders | Pfizer |
| a | 2006 | Varenicline | O | Addictive disorders | Pfizer |
| EMEA/H/C/002717 | 2013 | Vortioxetine | O | Depressive disorders | Lundbeck |
EPAR, European Public Assessment Report; O, oral route; IM, intramuscular; INH, inhalation.
a
These EPARs had no identifying number on EMA's website.