| Code | 5643C | ||||||||||
| MA number | 30/0289/17-S | ||||||||||
| Product Form: | cps end 10x90 mg (blis.OPA/Al/[HDPE/PE+DES z CaO/HDPE]/Al/PE) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
| Therapeutic Class: | 30 - ANTIDEPRESSIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | blister OPA/Al/[HDPE/PE+DES of CaO/HDPE]/Al/PE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 02.11.2017 |
| Pediatric warnings: | Yes |
| Dokument: |
VHS_Dulsevia 90 mg.pdf
|
| Dokument: |
VHS_súhrn_Dulsevia 90 mg.pdf
|
| PIL: |
PIL_Dulsevia 90 mg_cps end_10_2024.pdf
|
| SPC: |
SPC_Dulsevia 90 mg_cps end_10_2024.pdf
|
| Safety feature | Yes |
| Data update: | 20.05.2020 |
