| Code | 53713 | ||||||||||
| MA number | EU/1/96/011/002 | ||||||||||
| Product Form: | con inf 10x10 ml (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Baxter Holding B.V., Netherland | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 20 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application |
| MA issued: | 21.06.1996 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHCP Caelyx 18 10 12.pdf
|
| Dokument: |
DHPC Caelyx 25 11 2011.pdf
|
| SPC: |
CAELYX_texty_marec 2020.pdf
|
| Safety feature | Yes |
| Data update: | 07.04.2020 |
