Code | 6594E | ||||||||||
MA number | EU/1/24/1817/002 | ||||||||||
Product Form: | sol iru 1x1 ml/150 mg (striek.inj.napl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Celltrion Healthcare Hungary Kft., Hungary | ||||||||||
Therapeutic Class: | 14 - BRONCHODILATANTIA, ANTIASTHMATICA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 24 | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(4) similar biological application |
MA issued: | 16.05.2024 |
Validity: | 16.05.2029 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 13.06.2024 |