| Code | 0531C | ||||||||||
| MA number | 14/0371/16-S | ||||||||||
| Product Form: | tbl flm 70x10 mg (blis.Al/PVC/Al/OPA) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Medreg s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 14 - BRONCHODILATANTIA, ANTIASTHMATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister Al/PVC/Al/OPA | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 28.07.2016 |
| Pediatric posology: | Yes |
| SPC: |
SPC_Montelukast_medreg_12/2023.pdf
|
| PIL: |
PIL_Montelukast Medreg_12/2023.pdf
|
| Safety feature | Yes |
| Data update: | 12.02.2021 |
