| Code | 9027E | ||||||||||
| MA number | EU/1/24/1893/002 | ||||||||||
| Product Form: | tbl flm 90 (3x30)x40 mg (blis.Al/Al) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Merck Sharp & Dohme B.V., Netherland | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 48 | ||||||||||
| Container: | blister Al/Al | ||||||||||
| 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: | 12.02.2025 |
| Validity: | 12.02.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Welireg_Prirucka pre zdravotnickych pracovnikov.pdf
|
| Safety feature | Yes |
| Data update: | 17.02.2025 |
