| Code | 4024B | ||||||||||
| MA number | 30/0169/15-S | ||||||||||
| Product Form: | cps end 100x60 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(1) generic application |
| MA issued: | 29.04.2015 |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Dulsevia 30 mg_60 mg_cps end_10_2024.pdf
|
| SPC: |
SPC_Dulsevia 30 mg_60 mg_cps end_10_2024.pdf
|
| Safety feature | Yes |
| Data update: | 27.01.2020 |
