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PRODUCT DETAIL

Koselugo 25 mg tvrdé kapsuly

Code 8009D
MA number EU/1/21/1552/002
Product Form: cps dur 60x25 mg (fľ.HDPE)
MA Status: Ex - Conditional 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
L01EE Mitogen-activated protein kinase (MEK) inhibitors
L01EE04 Selumetinib
Shelf life: 36
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: 17.06.2021
Validity: 19.06.2023
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 03.05.2022
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