Table 2.
Methodological concerns expressed in CEESP reports.
| Brand name | INN | CEESP report publication date | Total methodological concerns | Minor methodological concerns | Important methodological concerns | Major methodological concerns | Major overall methodological concerns |
|---|---|---|---|---|---|---|---|
| Adempas® | Riociguat | 14/10/2014 | 14 | 6 | 4 | 4 |  |
| Botox® | Botulinum toxin | 25/11/2014 | 10 | 8 | 2 | 0 | |
| Daklinza® | Daclatasvir | 03/02/2015 | 12 | 4 | 8 | 0 | |
| Defitelio® | Defibrotide | 18/02/2014 | 14 | 2 | 10 | 2 |  |
| Entyvio® | Vedolizumab | 25/11/2014 | 11 | 7 | 4 | 0 | |
| Harvoni® | Ledipasvir /sofosbuvir | 26/05/2015 | 11 | 3 | 7 | 1 |  |
| Kadcyla® | Trastuzumab emtansine | 11/03/2014 | 2 | 2 | 0 | 0 | |
| Nexplanon® | Etonogestrel | 15/09/2015 | 9 | 9 | 0 | 0 | |
| Nplate® | Romiplostim | 03/02/2015 | 6 | 1 | 5 | 0 | |
| Olysio® | Simeprevir | 14/10/2014 | 17 | 12 | 4 | 1 |  |
| Rotarix® | Rotavirus | 22/07/2014 | 16 | 11 | 5 | 0 | |
| Rotateq® | Rotavirus | 16/09/2014 | 15 | 10 | 5 | 0 | |
| Sovaldi® | sofosbuvir | 15/04/2014 | 17 | 8 | 8 | 1 |  |
| Tecfidera® | dimethyl fumarate | 24/06/2014 | 23 | 20 | 3 | 0 | |
| Tivicay® | Dolutegravir | 27/05/2014 | 11 | 10 | 1 | 0 | |
| Viekirax® /Exviera® | Ombitasvir/ paritaprevir/ ritonavir Dasabuvir |
09/06/2015 | 11 | 5 | 5 | 1 |  |
| Xolair® | Omalizumab | 25/11/2014 | 16 | 9 | 7 | 0 | |
| Xtandi® | enzalutamide | 09/06/2015 | 12 | 9 | 2 | 1 |  |
| Zostavax® | Zoster vaccine | 15/04/2014 | 16 | 15 | 1 | 0 |