利拉鲁肽欧洲申报资料WC.pdf

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Procedural steps taken and scientific information after the authorisation
No Scope Opinion/ Commission Product Summary
Notification1 Decision Information
issued on Issued2/ affected3
amended on
II/0016 Update of section of the SmPC after the 20/09/2012 23/10/2012 SPC, Annex II, Following the assessment of PSUR 3 (covering the period from 1
assessment of PSURs 3 and 4 to include the PL July 2010 to 30 December 2010) and PSUR 4 (from 31
adverse drug reactions (ADRs) of December 2010 to 30 June 2011), the MAH submitted responses
anaphylactic reactions, rash and pruritus. with regards to several safety concerns including pruritus,
Update of section of the SmPC to mod