| Code | 2448E | ||||||||||
| MA number | 44/0288/22-S | ||||||||||
| Product Form: | tbl flm 60x16 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Zentiva, k.s., Czechia | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 01.12.2022 |
| Validity: | 01.12.2027 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Daruph 16 mg_03.2023.pdf
|
| PIL: |
PIL_Daruph 16 mg_03.2023.pdf
|
| Dokument: |
Daruph_ Priručka pre zdravotníckych pracovníkov.pdf
|
| Safety feature | Yes |
| Data update: | 08.12.2022 |
