Code | 0851E | ||||||||||
MA number | 20/0129/22-S | ||||||||||
Product Form: | sol inj 10(2x5)x2 ml/10 mg (amp.PP) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Noridem Enterprises Ltd., Cyprus | ||||||||||
Therapeutic Class: | 20 - ANTIEMETICA, ANTIVERTIGINOSA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 36 | ||||||||||
Container: | ampoule PP | ||||||||||
Route of admin.: | Intramuscular or intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 24.05.2022 |
Validity: | 24.05.2027 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Metoclopramide Noridem 5 mg/ml injekčný roztok 05_2022.pdf |
SPC: | SPC_Metoclopramide Noridem 5 mg_ml injekčný roztok_08_2023.pdf |
Safety feature | Yes |
Data update: | 25.08.2023 |