| Code | 0743F | ||||||||||
| MA number | 24/0246/25-S | ||||||||||
| Product Form: | tbl 50x20 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Zaklady Farmaceutyczne POLPHARMA S.A., Poland | ||||||||||
| Therapeutic Class: | 24 - ANTIHISTAMINICA, HISTAMIN | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 30.07.2025 |
| Validity: | 30.07.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Bilastine Polpharma_OTC_07.2025.pdf
|
| PIL: |
PIL_Bilastine Polpharma_Rx_07.2025.pdf
|
| SPC: |
SPC_Bilastine Polpharma_07.2025.pdf
|
| Safety feature | Yes |
| Data update: | 01.08.2025 |
