Module 12 2019

Your SPOR, Their SPOR

Levothyroxine 50 mcg film-coated tablets

Don´t forget!

Validation as performed by EMA.

RIMS

Production

EMA SPOR

Film coated tablets

Film-coated tablets

FCT

Changes in data as made in EVweb

50 micrograms

50 mcg

50 µg / 1 tablet

What is the truth? What to use for IDMP?

Levothyroxine Na

Levothyroxine Sodium

L-Thyroxine Na

The Organisation for Professionals in Regulatory Affairs

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