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Envarsus

1. NAME OF THE MEDICINAL PRODUCT
Envarsus 0.75 mg prolonged-release tablets
Envarsus 1 mg prolonged-release tablets
Envarsus 4 mg prolonged-release tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 0.75 mg of tacrolimus (in monohydrate form); or 1 mg of tacrolimus (in monohydrate form); or 4 mg of tacrolimus (in monohydrate form).
Excipient with known effect:
Each prolonged-release tablet contains 41.7 mg of lactose (in monohydrate form) in the 0.75 mg tablet; 41.7 mg of lactose (in monohydrate form) in the 1 mg tablet; or 104 mg of lactose (in monohydrate form) in the 4 mg tablet.

Further information can be found on the website:

http://www.ema.europa.eu