Code | 3324B | ||||||||||
MA number | EU/1/07/431/035 | ||||||||||
Product Form: | sol inj 6x0,5 ml/5000 IU (striek.inj.napl.skl. s ochr.kr.ihly) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Pfizer Europe MA EEIG, Belgium | ||||||||||
Therapeutic Class: | 12 - ANTIANAEMICA | ||||||||||
ATC: |
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Shelf life: | 30 | ||||||||||
Container: | glass pre-filled syringe | ||||||||||
Route of admin.: | Subcutaneous and intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(4) similar biological application |
MA issued: | 18.12.2007 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 18.09.2023 |