| Code | 2811F | ||||||||||
| MA number | 08/0052/26-S | ||||||||||
| Product Form: | sol ira 3x3 ml/18 mg (náplň skl. v napln.pere) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Zaklady Farmaceutyczne POLPHARMA S.A., Poland | ||||||||||
| Therapeutic Class: | 08 - ANOREXICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 18 | ||||||||||
| Container: | glass cartridge in pre-filled pen | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 17.03.2026 |
| Validity: | 17.03.2031 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Sudaclin_03.2025.pdf
|
| SPC: |
SPC_Sudaclin_03.2025.pdf
|
| Safety feature | Yes |
| Data update: | 20.03.2026 |
