| Code | 1212A | ||||||||||
| MA number | EU/1/12/753/001 | ||||||||||
| Product Form: | sol inj 6x1 ml/0,3 mg (amp.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Recordati Rare Diseases, France | ||||||||||
| Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 24.04.2012 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 17.06.2025 |
