re: Ann: EU Marketing Authorisation Applicati... I agree TGA approval does not guarantee other approvals.
We have seen that with Bronchitol.
Movectro was rejected due to safety concerns. There was an increase in patients with cancer after being on the drug. It may or may not be linked but the EMEA won't take the risk and rightly so on this one.
Ann: EU Marketing Authorisation Application Revie, page-6
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