WC500185968

5. Risk Management Plans ......................................................................... 26
5.1. Medicines in the pre-authorisation phase ............................................................... 26
5.1.1. Allogeneic cells genetically modified to express suicide gene ................................. 26
5.1.2. Asfotase alfa ................................................................................................... 27
5.1.3. Bortezomib ..................................................................................................... 27
5.1.4. Dexamethasone .............................................................................................. 27
5.1.5. Duloxetine ...................................................................................................... 27
5.1.6. Empagliflozin, metformin .................................................................................. 27
5.1.7. Human papillomavirus [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant,
adsorbed) ................................................................................................................ 27
5.1.8. Lenvatinib ...................................................................................................... 28
5.1.9. Levodopa, carbidopa ........................................................................................ 28
5.1.10. Mepolizumab ................................................................................................. 28
5.1.11. Nivolumab .................................................................................................... 28
5.1.12. Panobinostat ................................................................................................. 28
5.2. Medicines already authorised ............................................................................... 28
RMP in the context of a variation – PRAC-led procedure ................................................. 28
5.2.1. Oseltamivir – TAMIFLU (CAP) ............................................................................ 28
RMP in the context of a variation – CHMP-led procedure ................................................ 29
5.2.2. Crizotinib – XALKORI (CAP) .............................................................................. 29
5.2.3. Lenalidomide – REVLIMID (CAP) ........................................................................ 30
5.2.4. Ritonavir – NORVIR (CAP) ................................................................................ 31
5.2.5. Tigecycline – TYGACIL (CAP) ............................................................................. 31
RMP evaluated in the context of a PSUR procedure ....................................................... 32
RMP evaluated in the context of PASS results ............................................................... 32
RMP evaluated in the context of a renewal of the marketing authorisation, conditional
renewal or annual reassessment ................................................................................. 32
RMP evaluated in the context of a stand-alone RMP procedure ........................................ 32
6. Periodic Safety Update Reports (PSURs) ............................................... 33
6.1. Evaluation of PSUR procedures ............................................................................ 33
6.1.1. Bexarotene – TARGRETIN (CAP) ........................................................................ 33
6.1.2. Brimonidine – MIRVASO (CAP) .......................................................................... 34
6.1.3. Duloxetine – ARICLAIM (CAP), CYMBALTA (CAP), XERISTAR (CAP), YENTREVE (CAP)
.............................................................................................................................. 35
6.1.4. Enzalutamide – XTANDI (CAP) .......................................................................... 36
6.1.5. Mecasermin – INCRELEX (CAP) ......................................................................... 37
6.1.6. Nalmefene – SELINCRO (CAP) ........................................................................... 37
6.1.7. Natalizumab – TYSABRI (CAP) ........................................................................... 38
6.1.8. Pomalidomide – IMNOVID (CAP) ........................................................................ 39
6.1.9. Sitagliptin – JANUVIA (CAP), RISTABEN (CAP), TESAVEL (CAP), XELEVIA (CAP) ...... 41
6.1.10. Temozolomide – TEMODAL (CAP) ..................................................................... 41
6.1.11. Vemurafenib – ZELBORAF (CAP) ...................................................................... 42
6.1.12. Vernakalant – BRINAVESS (CAP) ..................................................................... 43
6.1.13. Zaleplon – SONATA (CAP), NAP ....................................................................... 44
6.1.14. Zoledronic acid – ACLASTA (CAP) .................................................................... 45
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 4/89