| Code | 8116D | ||||||||||
| MA number | 63/0206/21-S | ||||||||||
| Product Form: | sol inj 1x200 Speywoodových jednotiek/1 ml (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Ipsen Pharma, France | ||||||||||
| Therapeutic Class: | 63 - MYORELAXANTIA | ||||||||||
| ATC: |
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| Shelf life: | 12 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intramuscular use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 02.08.2021 |
| Validity: | 02.08.2026 |
| MA renewed: | Renewal application submitted |
| PIL: |
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| SPC: |
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| Safety feature | Yes |
| Data update: | 05.08.2021 |