| Code | 8096E | ||||||||||
| MA number | 14/0283/24-S | ||||||||||
| Product Form: | plv icd 30 (3x10)x18 µg (blis.PA/Al/PVC//Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Glenmark Pharmaceuticals s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 14 - BRONCHODILATANTIA, ANTIASTHMATICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | blister PA/Al/PVC/Al | ||||||||||
| Route of admin.: | Inhalation use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 27.11.2024 |
| Validity: | 27.11.2029 |
| PIL: |
PIL_Tiotropium Glenmark_11_2024.pdf
|
| SPC: |
SPC_Tiotropium Glenmark_11_2024.pdf
|
| Safety feature | Yes |
| Data update: | 28.11.2024 |
