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PRODUCT DETAIL

Skyclarys 50 mg tvrdé kapsuly

Code 5446E
MA number EU/1/23/1786/001
Product Form: cps dur 90x50 mg (fľ.HDPE)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
MAH, country: Biogen Netherlands B.V., Netherland
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: 09.02.2024
Validity: 09.02.2029
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 13.02.2024
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