ontaining 10 capsules per blister.
Advagraf 0.5 mg prolonged-release hard capsules
Pack sizes: 30, 50 and 100 prolonged-release hard capsules in blisters or 30×1, 50×1 and 100×1 prolonged-release hard capsules in unit-dose perforated blisters.
Advagraf 1 mg prolonged-release hard capsules
Pack sizes: 30, 50, 60 and 100 prolonged-release hard capsules in blisters or 30×1, 50×1, 60×1 and 100×1 prolonged-release hard capsules in unit-dose perforated blisters.
Advagraf 3 mg prolonged-release hard capsules
Pack sizes: 30, 50 and 100 prolonged-release hard capsules in blisters or 30×1, 50×1 and 100×1 prolonged-release hard capsules in unit-dose perforated blisters.
Advagraf 5 mg prolonged-release hard capsules
Pack sizes: 30, 50 and 100 prolonged-release hard capsules in blisters or 30×1, 50×1 and 100×1 prolonged-release hard capsules in unit-dose perforated blisters.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements.
7. Marketing authorisation holder
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
Netherlands
8. Marketing authorisation number(s)
Advagraf 0.5 mg prolonged-release hard capsules
EU/1/07/387/001
EU/1/07/387/002
EU/1/07/387/009
EU/1/07/387/014
EU/1/07/387/015
EU/1/07/387/016
Advagraf 1 mg prolonged-release hard capsules
EU/1/07/387/003
EU/1/07/387/004
EU/1/07/387/005
EU/1/07/387/006
EU/1/07/387/017
EU/1/07/387/018
EU/1/07/387/019
EU/1/07/387/020
Advagraf 3 mg prolonged-release hard capsules
EU/1/07/387/011
EU/1/07/387/012
EU/1/07/387/013
EU/1/07/387/021
EU/1/07/387/022
EU/1/07/387/023
Advagraf 5 mg prolonged-release hard capsules
EU/1/07/387/007
EU/1/07/387/008
EU/1/07/387/010
EU/1/07/387/024
EU/1/07/387/025
EU/1/07/387/026
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 23 April 2007
Date of latest renewal: 13 April 2012
10. Date of revision of the text
25 June 2015
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.