| Code | 1213C | ||||||||||
| MA number | 87/0432/16-S | ||||||||||
| Product Form: | cps mol 30x0,5 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| 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: | 26.09.2016 |
| Pediatric contraindication: | Yes |
| SPC: |
SPC_Dutalan_11.2019.docx
|
| PIL: |
PIL_Dutalan_09.2023.pdf
|
| Safety feature | Yes |
| Data update: | 13.05.2022 |
