Code | 4338D | ||||||||||
MA number | 76/0093/20-S | ||||||||||
Product Form: | sol inf 1x1000 ml (vak dvojkomor.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Fresenius Kabi s.r.o., Czechia | ||||||||||
Therapeutic Class: | 76 - INFUNDIBILIA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | bag | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 29.04.2020 |
Validity: | 29.04.2025 |
MA renewed: | Renewal application submitted |
Pediatric contraindication: | Yes |
SPC: |
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PIL: |
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Safety feature | No |
Data update: | 30.04.2020 |