| Code | 4758E | ||||||||||
| MA number | 56/0249/23-S | ||||||||||
| Product Form: | tbl slg 60x1x120 µg (blis.OPA/Al/PVC/PE-Al - jednotk.bal.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Teva B.V., Netherland | ||||||||||
| Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 30 | ||||||||||
| Route of admin.: | Sublingual use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 25.10.2023 |
| Validity: | 25.10.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Dezmopresín Teva_10.2023.pdf
|
| PIL: |
PIL_Dezmopresín Teva_02_2024.pdf
|
| Safety feature | Yes |
| Data update: | 14.11.2023 |
