| Code | 11445 | ||||||||||
| MA number | EU/1/01/176/009 | ||||||||||
| Product Form: | sol inf 5x100 ml/4 mg (fľ.inf.plast.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Phoenix Labs Unlimited Company, Ireland | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| 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: | 20.03.2001 |
| SmPC + PL: |
|
| Safety feature | Yes |
| Data update: | 07.04.2021 |