| Code | 9837E | ||||||||||
| MA number | 83/0161/25-S | ||||||||||
| Product Form: | tbl 60x16 mg (blis. PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Medreg s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 83 - VASODILATANTIA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 48 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 04.06.2025 |
| Validity: | 04.06.2030 |
| PIL: |
PIL_Betahistine Medreg 16 mg_05_2025.pdf
|
| SPC: |
SPC_Betahistine Medreg 16 mg_05_2025.pdf
|
| Safety feature | Yes |
| Data update: | 12.06.2025 |
