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Glossary

International Birth Date (IBD)

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The date of the first marketing authorization for any product containing the active substance granted to any company in any country in the world.

Other glossary definitions

P

Patient Reported Outcome (PRO)

A measurement based on a report that comes directly from the patient (i.e., study subject)…

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P

Periodic Safety Update Report (PSUR)

The PSUR provides an evaluation of the risk-benefit balance of a medicinal product defined time…

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