Code | 8874E | ||||||||||
MA number | EU/1/24/1886/004 | ||||||||||
Product Form: | tbl flm 14(1x14)x240 mg (blis.PVC/PCTFE/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Janssen - Cilag International N.V., Belgium | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
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: | 20.01.2025 |
Validity: | 20.01.2030 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 30.01.2025 |