n 1% of the parent drug is recovered in faeces.
5.3 Preclinical safety data
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Microcrystalline cellulose (E460)
Calcium hydrogen phosphate, anhydrous
Maize starch
Amberlite (polacrilin potassium)
Povidone (polyvidone)
Glycerol 85%
Magnesium stearate
Meglumine
Poloxamer
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
