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Emgality Summary of Product Characteristics (SmPC)
Changes to the galcanezumab pre-filled pen carton and packaging materials occurred in August 2020. Slight changes to the carton size, carton closure and the location of the carton graphics were implemented.
tamper evident seal was removed and replaced by a glue dot.
orientation of the information contained on the label and
Instructions for Use was slightly changed. It might not be noticeable
to the user.1
lock ring position on the pre-filled pen should be in the locked
position when a new carton is first opened and the pre-filled pen is
first removed from the carton. There are multiple checks in the
manufacturing process to ensure the lock ring is in the locked
position during assembly and labeling.1
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions.
Date of Last Review:September 30, 2020
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