EN PL

MHRA: Additional hypotensive effects following co-administration of non-selective alpha-blockers and phosphodiesterase-5-inhibitors: Guidance for marketing authorisation holders.

19.05.2009
Requirement for marketing authorisation holders to submit Type II variations by 15 June 2009 to update licences with additional guidance on hypotensive effects. During the discussion of this safety concern a relevant number of marketing authorisation holders (MAHs) for non-selective alpha-blockers may have incorporated some kind of wording in the SPC of their drugs on their own initiative to address this issue.