| Code | 0139F | ||||||||||
| MA number | 73/0200/25-S | ||||||||||
| Product Form: | tbl plg 50x50 mg (blis.ALU-OPA/ALU/PVC) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Glenmark Pharmaceuticals s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 73 - SPASMOLYTICA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | blister Al/OPA/Al/PVC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 30.05.2025 |
| Validity: | 30.05.2030 |
| SPC: |
SPC_Mirabegron Glenmark 50 mg_tbl plg_05/2025_REG.pdf
|
| PIL: |
PIL_Mirabegron Glenmark 50 mg_tbl plg_05/2025_REG.pdf
|
| Safety feature | Yes |
| Data update: | 20.06.2025 |
