| Code | 2908E | ||||||||||
| MA number | 63/0139/18-S | ||||||||||
| Product Form: | sol inf 10x5 ml/10 mg (amp.skl.-fialový krúž.v steril.plast.blis.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Sintetica GmbH, Germany | ||||||||||
| Therapeutic Class: | 63 - MYORELAXANTIA | ||||||||||
| ATC: |
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| Shelf life: | 60 | ||||||||||
| Container: | glass ampoule | ||||||||||
| Route of admin.: | Intrathecal use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 28.06.2018 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| SPC: |
SPC_Baclofen Sintetica 2mg_ml infúzny roztok_01_2023.pdf
|
| PIL: |
PIL_Baclofen Sintetica 2mg_ml infúzny roztok_02_2023.pdf
|
| Safety feature | Yes |
| Data update: | 17.03.2023 |
