| Code | 3214E | ||||||||
| MA number | 94/0069/23-S | ||||||||
| Product Form: | tbl obd 30x36 mg/36 mg/36 mg (blis.PVC/PVDC/Al) | ||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||
| MAH, country: | Bionorica SE, Germany | ||||||||
| Therapeutic Class: | 94 - FYTOPHARMACA | ||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||
| Container: | blister PVC/PVDC/Al | ||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 18.05.2023 |
| Validity: | 18.05.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Cystipret_03_2023.pdf
|
| SPC: |
SPC_Cystipret_03_2023.pdf
|
| Safety feature | No |
| Data update: | 13.03.2025 |
