Amarin Corp Plc (AMRN)

[HDGabor]

l-

Does the EPAR have the final final say

EPAR is not a "body". It is

A set of documents describing the evaluation of a medicine authorised via the centralised procedure and including the product information, published on the European Medicines Agency website. European public assessment reports include the product information. Abbreviated as EPAR.

EPARs are updated periodically to reflect the latest regulatory information on medicines.

Timing of publication
The EPAR for each medicine is published or updated after the European Commission has issued a decision regarding the application. In addition, whenever the product information is updated, the medicine's EPAR is updated accordingly to reflect the latest version.

For a new marketing authorisation or a major change to the authorisation terms, this process takes around two months following the adoption of an EMA scientific opinion, so there is a delay between adoption of opinion and publication or updating of the EPAR. Pending the European Commission decision, the EMA publishes a 'summary of opinion' immediately after the scientific opinion is adopted.

European public assessment report

European public assessment reports: background and context

Vazkepa was approved ... it is done, no more evaluation / decision ... it was the final / last step (other than the necessary administrative actions, e.g. inform Amarin)

Please note: post on a website is not the official notification to Amarin ...

Best,
G