Revised SPC: Symkevi 100 mg (tezacaftor)/150 mg (ivacaftor) film coated tablets

SPC revised with addition of new strength (50 mg/75 mg) tablets and its indication and a table with dosing recommendations for patients aged 6 years and older as a result of the new strength.

SPS commentary:

Clarification has been added regarding tablet formulation in that they should not be chewed, crushed or broken before swallowing due to lack of clinical data currently to support other methods of administration.  Also advice that Seville oranges as example of a food and drink to be avoided during treatment has been removed.

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