| Code | 6497D | ||||||||||
| MA number | EU/1/20/1508/001 | ||||||||||
| Product Form: | plc ifc 1x100 mg (liek.inj.skl.jantár.) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Daiichi Sankyo Europe GmbH, Germany | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 48 | ||||||||||
| Container: | glass vial | ||||||||||
| 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: | 18.01.2021 |
| Validity: | 20.01.2027 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
ENHERTU_Príručka pre zdravotníckych pracovníkov.pdf
|
| Dokument: |
ENHERTU_Karta pacienta.pdf
|
| Dokument: |
ENHERTU_Príručka pre zdravotníckych pracovníkov k prevencii chýb v liečbe.pdf
|
| Safety feature | Yes |
| Data update: | 05.12.2025 |
