| Code | 7004D | ||||||||||
| MA number | 58/0063/21-S | ||||||||||
| Product Form: | sol ijf 5x5 ml/25 mg (amp.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | AS KALCEKS, Latvia | ||||||||||
| Therapeutic Class: | 58 - HYPOTENSIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | glass ampoule | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 15.04.2021 |
| Validity: | 15.04.2026 |
| MA renewed: | Renewal application submitted |
| SPC: |
SPC_Urapidil Kalceks_08/2022.pdf
|
| PIL: |
PIL_Urapidil Kalceks _11/2022.pdf
|
| Safety feature | Yes |
| Data update: | 12.08.2022 |
