Polyvinyl alcohol (partially hydrolysed) (E1203)
Titanium dioxide (E171)
Macrogol 3350 (E1521)
Talc (E553b)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
PVC/PCTFE/PVC/Al blister
The blisters are packaged in a carton.
Pack sizes of 90 and 180 tablets. Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
Ipsen Pharma
65 quai Georges Gorse
92100 Boulogne-Billancourt
France
8. Marketing authorisation number(s)
EU/1/17/1224/001
EU/1/17/1224/002
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 18 September 2017
10. Date of revision of the text
16 January 2018
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. |
