Code | 1431E | ||||||||||
MA number | 20/0186/22-S | ||||||||||
Product Form: | sol inf 20x50 ml/8 mg (fľ.LDPE) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Fresenius Kabi Deutschland GmbH, Germany | ||||||||||
Therapeutic Class: | 20 - ANTIEMETICA, ANTIVERTIGINOSA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | bottle LDPE | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 01.07.2022 |
Validity: | 01.07.2027 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: |
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SPC: |
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Safety feature | Yes |
Data update: | 11.04.2024 |