Iron oxide, yellow (1 mg tablets only) (E172)

Iron oxide, red (2 mg tablets only) (E172)

6.2 Incompatibilities

 Not applicable.

6.3 Shelf life

 5 years.
6.4 Special precautions for storage

 Store in the original package.
6.5 Nature and contents of container

 The blister pack (aluminium/aluminium) contains 30, 90, 120 or 270 tablets, respectively.

Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling

 No special requirements.
7. MARKETING AUTHORISATION HOLDER

 Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

8. MARKETING AUTHORISATION NUMBER(S)
 NovoNorm 0.5 mg tablets EU/1/98/076/004-006, EU/1/98/076/023

NovoNorm 1 mg tablets EU/1/98/076/011-013, EU/1/98/076/024

NovoNorm 2 mg tablets EU/1/98/076/018-020, EU/1/98/076/022
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 17 August 1998

Date of last renewal: 23 July 2008

10. DATE OF REVISION OF THE TEXT

 12/2008