conjugate of obeticholic acid was found in pups nursing from dams dosed with obeticholic acid
6. Pharmaceutical particulars
6.1 List of excipients
Tablet core
Microcrystalline cellulose (E460)
Sodium starch glycolate (Type A)
Magnesium stearate
Tablet coating
Poly(vinyl alcohol), partially hydrolysed (E1203)
Titanium dioxide (E171)
Macrogol 3350 (E1521)
Talc (E553b)
Iron oxide yellow (E172)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
High-density polyethylene (HDPE) bottles with a child resistant polypropylene closure and an aluminium foil induction seal.
Pack size: 30 or 100 film-coated 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
Intercept Pharma Ltd.
2 Pancras Square
London, N1C 4AG
United Kingdom
8. Marketing authorisation number(s)
EU/1/16/1139/001
EU/1/16/1139/002
EU/1/16/1139/003
EU/1/16/1139/004
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 12/12/2016
Date of latest renewal: 01 December 2017
10. Date of revision of the text
23/03/2018
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. |
