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PRODUCT DETAIL

Inrebic 100 mg tvrdé kapsuly

Code 6938D
MA number EU/1/20/1514/001
Product Form: cps dur 120x100 mg (fľ.HDPE)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01E Protein kinase inhibitors
L01EJ Janus Associated Kinase (JAK) inhibitors
L01EJ02 Fedratinib
Shelf life: 48
Container: bottle HDPE
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 08.02.2021
Validity: 08.02.2026
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 26.10.2021
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