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PRODUCT DETAIL

Ketoconazole HRA 200 mg tablety

Code 2898B
MA number EU/1/14/965/001
Product Form: tbl 60x200 mg (blis.PVC/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
Therapeutic Class: 34 - ANTIHORMONA
ATC:
H SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H02C ANTIADRENAL PREPARATIONS
H02CA Anticorticosteroids
H02CA03 Ketoconazole
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: 19.11.2014
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 28.07.2021
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