Code | 4647D | ||||||||||
MA number | 58/0121/20-S | ||||||||||
Product Form: | cps pld 30x90 mg (fľ.HDPE) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Medreg s.r.o., Czechia | ||||||||||
Therapeutic Class: | 58 - HYPOTENSIVA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 12.06.2020 |
Validity: | 12.06.2025 |
MA renewed: | Renewal application submitted |
PIL: | PIL_Urapidil Medreg_03_2021.pdf |
SPC: | SPC_Urapidil Medreg_07/2023.pdf |
Safety feature | Yes |
Data update: | 29.03.2021 |