Code | 4191E | ||||||||||
MA number | EU/1/20/1501/004 | ||||||||||
Product Form: | sol inj 5 (5x1)x1,5 ml/5 mg (pero napl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | pre-filled pen | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 31.03.2021 |
Validity: | 31.03.2026 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 28.07.2023 |