Code | 7997D | ||||||||||
MA number | 41/0170/21-S | ||||||||||
Product Form: | sol inf 5x50 ml (liek.inj.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | hameln pharma gmbh, Germany | ||||||||||
Therapeutic Class: | 41 - CARDIACA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 36 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 16.07.2021 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Dobutamin hameln 5 mg/ml infúzny roztok_09_2022.pdf |
PIL: | PIL_Dobutamin hameln 5 mg/ml infúzny roztok_09_2022.pdf |
Safety feature | Yes |
Data update: | 17.06.2022 |