| Code | 0780F | ||||||||||
| MA number | 34/0214/25-S | ||||||||||
| Product Form: | sol inj 1x0,9 ml/6,75 mg (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | ARDEZ Pharma, spol. s r.o., Czechia | ||||||||||
| Therapeutic Class: | 34 - ANTIHORMONA | ||||||||||
| ATC: |
|
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| Shelf life: | 30 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 19.08.2025 |
| Validity: | 19.08.2030 |
| SPC: |
SPC_Atosiban Ardez 6,75 mg_0,9 ml_07 2025.pdf
|
| PIL: |
PIL_Atosiban Ardez 6,75 mg_0,9 ml_07 2025.pdf
|
| Safety feature | Yes |
| Data update: | 08.09.2025 |
