e shell:
Gelatin
Brilliant Blue (E133)
Allura Red AC (E129)
Titanium dioxide (E171)
Sunset Yellow FCF (E110)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
21months
Shelf-life after first opening container: 45 days.
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
HDPE bottles with a child-proof polypropylene push-lock. Each bottle contains 56 capsules.
6.6 Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorisation holder
Norgine B.V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
Netherlands
8. Marketing authorisation number(s)
EU/1/15/1075/001
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 18 February 2016
10. Date of revision of the text
31 January 2019
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. |