Code | 7754A | ||||||||||
MA number | EU/1/13/871/001 | ||||||||||
Product Form: | sol inj 1x300 IU/0,5 ml+10 inj.ihiel (náplň skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Theramex Ireland Limited, Ireland | ||||||||||
Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass cartrige | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(4) similar biological application |
MA issued: | 27.09.2013 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 06.07.2020 |