Code | 0816E | ||||||||||
MA number | EU/1/20/1494/002 | ||||||||||
Product Form: | sol inj 1x1,5 ml/284 mg (striek.inj.skl.+chránič ihly) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Novartis Europharm Limited, Ireland | ||||||||||
Therapeutic Class: | 31 - HYPOLIPIDAEMICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | injection syringe | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 09.12.2020 |
Validity: | 09.12.2025 |
SmPC + PL: |
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Dokument: |
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Safety feature | Yes |
Data update: | 17.05.2022 |