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PRODUCT DETAIL

Evrysdi 0,75 mg/ml prášok na perorálny roztok

Code 7302D
MA number EU/1/21/1531/001
Product Form: plo por 1x60 mg ((fľ.skl.jantár+adapter+striek.(2x1 ml+2x6 ml+1x12 ml))
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Roche Registration GmbH, Germany
Therapeutic Class: 87 - VARIA I
ATC:
M MUSCULO-SKELETAL SYSTEM
M09 OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL
M09A OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL
M09AX Other drugs for disorders of the musculo-skeletal
M09AX10 Risdiplam
Shelf life: 24
Container: amber glass bottle
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 26.03.2021
Validity: 26.03.2026
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 14.11.2023
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