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 |
SPC: | SPC_Urapidil Kalceks_08/2022.pdf |
PIL: | PIL_Urapidil Kalceks _11/2022.pdf |
Safety feature | Yes |
Data update: | 12.08.2022 |