Code | 7083D | ||||||||||
MA number | EU/1/20/1506/004 | ||||||||||
Product Form: | sol inj 1x3 ml/300 U (pero napl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Biosimilar Collaborations Ireland Limited, Ireland | ||||||||||
Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
ATC: |
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Shelf life: | 30 | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(4) similar biological application |
MA issued: | 05.02.2021 |
Validity: | 05.02.2026 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 08.09.2023 |