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8.3.15. Tafamidis – VYNDAQEL (CAP) - EMEA/H/C/0002294/R/0032 (without RMP)<br />
Applicant: Pfizer Limited<br />
PRAC Rapporteur: Isabelle Robine<br />
Scope: 5-year renewal of the marketing authorisation<br />
Action: For adoption of advice to CHMP<br />
9. Product related pharmacovigilance inspections<br />
9.1. List of planned pharmacovigilance inspections<br />
None<br />
9.2. Ongoing or concluded pharmacovigilance inspections<br />
9.3. Others<br />
Disclosure of information on results of pharmacovigilance inspections could undermine the<br />
protection of the purpose of these inspections, investigations and audits. Therefore such<br />
information is not reported in the agenda.<br />
10. Other safety issues for discussion requested by the CHMP or<br />
the EMA<br />
10.1. Safety related variations of the marketing authorisation<br />
None<br />
10.2. Timing and message content in relation to Member States’ safety<br />
announcements<br />
None<br />
10.3. Other requests<br />
None<br />
10.4. Scientific Advice<br />
Disclosure of information related to this section cannot be released at the present time as it<br />
is deemed to contain commercially confidential information.<br />
11. Other safety issues for discussion requested by the Member<br />
States<br />
11.1. Safety related variations of the marketing authorisation<br />
None<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/325452/2016 Page 47/52
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