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PRODUCT DETAIL

Spexotras 0,05 mg/ml prášok na perorálny roztok

Code 5267E
MA number EU/1/23/1781/001
Product Form: plo por 1x4,7 mg (fľ.skl.hnedá + 1 adaptér + striek.per.)
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
L01EE Mitogen-activated protein kinase (MEK) inhibitors
L01EE01 Trametinib
Shelf life: 36
Container: brown glass bottle
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10a well-established use application
MA issued: 05.01.2024
Validity: 05.01.2029
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 18.01.2024
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