| Code | 2618E | ||||||||||
| MA number | EU/1/22/1700/001 | ||||||||||
| Product Form: | dis inj 1-6x1 ml (liek.inj.COC) | ||||||||||
| MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Pierre Fabre Médicament, France | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
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| Shelf life: | 72 | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 16.12.2022 |
| Validity: | 16.12.2027 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | No |
| Data update: | 24.01.2025 |
