Code | 9529D | ||||||||||
MA number | 76/0019/22-S | ||||||||||
Product Form: | emu inf 4x1 539 ml (vak Biofine) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Fresenius Kabi s.r.o., Czechia | ||||||||||
Therapeutic Class: | 76 - INFUNDIBILIA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | bag Biofin | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 01.02.2022 |
Validity: | 01.02.2027 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
PIL: |
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SPC: |
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Safety feature | No |
Data update: | 15.12.2022 |