sp;Transparent PVC/PVDC aluminium blister or unit-dose perforated blister wrapped in an aluminium wrapper with a desiccant containing 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.
Go to top of the page6.6 Special precautions for disposal and other handling
No special requirements.
Go to top of the page7. Marketing authorisation holder
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
Netherlands
Go to top of the page8. 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
Go to top of the page9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 23 April 2007
Date of latest renewal: 13 April 2012
Go to top of the page10. Date of revision of the text
18 February 2013
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
More information about this product
•Patient Information Leaflets (PILs):
Advagraf 0.5mg, 1mg, 3mg and 5mg Prolonged-release hard capsules
Link to this document from your website: http://www.medicines.org.uk/emc/medicine/19814/SPC/
