| Code | 3344E | ||||||||||
| MA number | 59/0078/23-S | ||||||||||
| Product Form: | sol inf 1x10 ml/1 000 U (liek.inj.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | BIOTEST PHARMA GMBH, Germany | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 03.05.2023 |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
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| SPC: |
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| Safety feature | Yes |
| Data update: | 27.10.2023 |