| Code | 8982E | ||||||||||
| MA number | 54/0039/25-S | ||||||||||
| Product Form: | cps vad 8x10^8 CFU/10^8 CFU (obal Al viacdávk.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Onapharm s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 54 - GYNAECOLOGICA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | multidose container | ||||||||||
| Route of admin.: | Vaginal use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 10.02.2025 |
| Validity: | 10.02.2030 |
| Pediatric posology: | Yes |
| SPC: |
SPC_Gynium_02 2025.pdf
|
| PIL: |
PIL_Gynium_08 2025.pdf
|
| Safety feature | No |
| Data update: | 11.02.2025 |
