WC500185968
WC500185968
WC500185968
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11. Other Safety issues for discussion requested by the<br />
Member States<br />
11.1. Safety related variations of the marketing authorisation<br />
11.1.1. Azithromycin oral and intravenous formulations (NAP)<br />
<br />
PRAC consultation on a safety-related variations upon Finland’s request<br />
Regulatory details:<br />
Lead member: Terhi Lehtinen (FI)<br />
Administrative details:<br />
Procedure number: FI/H/XXXX/WS/23<br />
Procedure scope: PRAC consultation on a variation procedure evaluating the draft PASS protocol<br />
(A0661209) for a non-imposed non-interventional study in the Kaiser Permanente databases to<br />
examine the effects of azithromycin use on cardiovascular outcome<br />
MAH(s): Pfizer (Zithromax)<br />
Background<br />
Azithromycin is a macrolide antibiotic indicated for the treatment of infections caused by susceptible<br />
organisms (respiratory, skin and subcutaneous tissue, sexually transmitted disease (STD)).<br />
Azithromycin is also indicated in long term use in patients with advanced HIV infection for prophylaxis<br />
and treatment against Mycobacterium avium intracellular complex (MAC/DMAC).<br />
For background information, see PRAC Minutes January 2015. Following previous advice, the PRAC was<br />
further consulted on the evaluation of the MAH’s responses to a list of questions.<br />
Summary of advice and conclusion(s)<br />
Based on the review of the available information, the PRAC acknowledged the limitations in the<br />
proposed Veterans Affairs (VA) database study, and supported Finland’s view on potential confounding<br />
by indication and severity. The PRAC also supported that the population in the proposed study might<br />
not be representative of the population of interest. Therefore, the PRAC agreed with Finland’s<br />
conclusions that did not support the proposal to perform the VA database study, while PRAC agreed<br />
with pursuing studies using the Kaiser Permanente databases (North and South California; KPNC and<br />
KPSC).<br />
11.2. Renewals of the Marketing Authorisation<br />
None<br />
11.3. Other requests<br />
11.3.1. Iron for intravenous (IV) use (NAP)<br />
<br />
PRAC consultation on the evaluation of a PASS feasibility study upon Member State’s request<br />
Regulatory details:<br />
Lead member: Arnaud Batz (FR)<br />
Administrative details:<br />
Procedure number: Not applicable<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/257790/2015 Page 53/89
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