en

PRODUCT DETAIL

Orladeyo 150 mg tvrdé kapsuly

Code 7610D
MA number EU/1/21/1544/002
Product Form: cps dur 98x150 mg (blis.PCTFE/PVC/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 87 - VARIA I
ATC:
B BLOOD AND BLOOD FORMING ORGANS
B06 OTHER HEMATOLOGICAL AGENTS
B06A OTHER HEMATOLOGICAL AGENTS
B06AC Drugs used in hereditary angioedema
B06AC06 Berotralstat
Shelf life: 48
Container: blister PCTFE/PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 30.04.2021
Validity: 30.04.2026
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 24.01.2024
eu-flag.png sk-flag.png