| Code | 0851F | ||||||||||
| MA number | EU/1/25/1950/001 | ||||||||||
| Product Form: | tbl dsp 42x1 mg (fľ.HDPE) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | SpringWorks Therapeutics Ireland Limited, Ireland | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| 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: | 17.07.2025 |
| Validity: | 17.07.2026 |
| Safety feature | Yes |
| Data update: | 08.08.2025 |
