| Code | 6496C | ||||||||||
| MA number | 01/0416/17-S | ||||||||||
| Product Form: | sol ifp 1x250 ml (fľ.HDPE+vrecko+katéter 15 cm ) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | BioQ Pharma B.V., Netherland | ||||||||||
| Therapeutic Class: | 01 - ANAESTHETICA (LOKÁLNE) | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Perineural use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 22.12.2017 |
| Validity: | 22.12.2022 |
| MA renewed: | Renewal application submitted |
| PIL: |
pil_ropivacaine readyfusor_02_2019.docx
|
| SPC: |
SPC_Ropivacaine Readyfusor_04_2019.docx
|
| Safety feature | Yes |
| Data update: | 24.04.2019 |
