| Code | 2154F | ||||||||||
| MA number | 56/0394/25-S | ||||||||||
| Product Form: | sol iru 3x0,5 ml/60 mg (striek.inj.napln.PP+ihla) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Zentiva, k.s., Czechia | ||||||||||
| Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | pre-filled syringe PP | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 18.12.2025 |
| Validity: | 18.12.2030 |
| SPC: |
SPC_Lanreotide Zentiva 60 mg_120 mg_12 2025.pdf
|
| PIL: |
PIL_Lanreotide Zentiva 60 mg_120 mg_01_2026.pdf
|
| Safety feature | Yes |
| Data update: | 08.01.2026 |
