Code | 4745E | ||||||||||
MA number | 56/0250/23-S | ||||||||||
Product Form: | tbl slg 90x1x240 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: |
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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 |