Code | 9571D | ||||||||||
MA number | EU/1/21/1607/001 | ||||||||||
Product Form: | plv iol 4x3 mg+4x0,279 ml solv.+6xihla (náplň dvojkom.skl.) | ||||||||||
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: | 36 | ||||||||||
Container: | double-chamber glass cartrige | ||||||||||
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: | 11.01.2022 |
Validity: | 11.01.2027 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 08.09.2022 |