| Code | 2762F | ||||||||||
| MA number | 78/0057/26-S | ||||||||||
| Product Form: | tbl plg 60 (2x30) x36 mg (fľ.HDPE-multibal.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Exeltis Slovakia s.r.o., Slovakia | ||||||||||
| Therapeutic Class: | 78 - SYMPATHOMIMETICA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 13.03.2026 |
| Validity: | 13.03.2031 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Balipre_02_2026.pdf
|
| SPC: |
SPC_Balipre_02_2026.pdf
|
| Safety feature | Yes |
| Data update: | 13.03.2026 |
