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PRODUCT DETAIL

Orphacol 250 mg tvrdé kapsuly

Code 7401A
MA number EU/1/13/870/005
Product Form: cps dur 60x250 mg (blis.PVC/Al)
MA Status: Ev - Valid centralised marketing authorisation under exceptional circumstances
Type of procedure: EU Orphan
MAH, country: THERAVIA, France
Therapeutic Class: 43 - CHOLERETICA, CHOLEKINETICA
ATC:
A ALIMENTARY TRACT AND METABOLISM
A05 BILE AND LIVER THERAPY
A05A BILE THERAPY
A05AA Bile acids and derivatives
A05AA03 Cholic acid
Shelf life: 36
Container: blister PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10a well-established use application
MA issued: 12.09.2013
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 07.05.2019
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