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12.8.1. Post-Authorisation Safety Studies .................................................................... 46
12.9. Community Procedures ..................................................................................... 47
12.10. Risk communication and Transparency .............................................................. 47
12.11. Continuous pharmacovigilance ......................................................................... 47
12.11.1. Marketing cessation, marketing suspension and withdrawals of medicinal products
from the market ....................................................................................................... 47
12.12. Interaction with EMA Committees and Working Parties ........................................ 47
12.12.1. Paediatric Committee (PDCO) ........................................................................ 47
12.12.2. Pharmacovigilance Inspectors Working Group (PhV IWG) .................................. 47
12.13. Interaction within the EU regulatory network ...................................................... 47
12.14. Contacts of the PRAC with external parties and interaction of the EMA with interested
parties ..................................................................................................................... 47
12.14.1. International Organisation for Standardisation (ISO) - Identification of Medicinal
Products (IDMP) standards ......................................................................................... 47
13. Any other business .............................................................................. 48
13.1. EMA move in 2014 to new building ..................................................................... 48
13.2. EMA reorganisation ........................................................................................... 48
13.3. Procedural Advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment
principles, objective criteria and methodology .............................................................. 48
14. ANNEX I Risk Management Plans ........................................................ 49
Medicines in the pre-authorisation phase ..................................................................... 49
14.1.1. Clopidogrel, acetylsalicylic acid ........................................................................ 49
14.1.2. Daclatasvir .................................................................................................... 49
14.1.3. Darunavir, cobicistat ...................................................................................... 49
14.1.4. Edoxaban ..................................................................................................... 49
14.1.5. Flutemetamol F-18 ......................................................................................... 49
14.1.6. Lutetium, isotope of mass 177 ......................................................................... 49
14.1.7. Mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches ..................... 50
14.1.8. Naloxegol ..................................................................................................... 50
14.1.9. Ramucirumab ................................................................................................ 50
14.1.10. Tedizolid ..................................................................................................... 50
Medicines already authorised ...................................................................................... 50
RMP in the context of a variation – PRAC-led procedure ................................................. 50
14.1.11. Adalimumab – HUMIRA (CAP) ........................................................................ 50
14.1.12. Dabigatran – PRADAXA (CAP) ........................................................................ 51
14.1.13. Everolimus – VOTUBIA (CAP) ........................................................................ 51
14.1.14. Fondaparinux – ARIXTRA (CAP) ..................................................................... 51
14.1.15. Insulin glulisine – APIDRA (CAP) .................................................................... 51
14.1.16. Prucalopride – RESOLOR (CAP) ...................................................................... 51
14.1.17. Sildenafil – REVATIO (CAP) ........................................................................... 52
14.1.18. Strontium ranelate – OSSEOR (CAP), PROTELOS (CAP) .................................... 52
14.1.19. Telmisartan – KINZALMONO (CAP), MICARDIS (CAP), PRITOR (CAP) .................. 52
14.1.20. Telmisartan, hydrochlorothiazide – KINZALKOMB (CAP), MICARDISPLUS (CAP),
PRITORPLUS (CAP) ................................................................................................... 52
RMP in the context of a variation – CHMP-led procedure ................................................ 53
14.1.21. Abatacept – ORENCIA (CAP) .......................................................................... 53
14.1.22. Aflibercept – EYLEA (CAP) ............................................................................. 53
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 7/75