| Code | 2404F | ||||||||||
| MA number | 87/0008/26-S | ||||||||||
| Product Form: | plv fol 1x4 000 mg+1x160 ml solv. (liek.inj.skl.+liek.inj.skl.+prenos.súprava) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Grifols Deutschland GmbH, Germany | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 07.02.2026 |
| Validity: | 07.02.2031 |
| PIL: |
PIL_Prolastina 4 000 mg; 5 000 mg prášok a rozpúšťadlo na infúzny roztok_01.2026.pdf
|
| SPC: |
SPC_Prolastina 4 000 mg; 5 000 mg prášok a rozpúšťadlo na infúzny roztok_01.2026.pdf
|
| Safety feature | Yes |
| Data update: | 12.02.2026 |
