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PRODUCT DETAIL

Ceplene 0,5 mg/0,5 ml injekčného roztoku

Code 53852
MA number EU/1/08/477/001
Product Form: sol inj 14x0,5 ml/0,5 mg (liek.inj.skl.)
MA Status: Ev - Valid centralised marketing authorisation under exceptional circumstances
Type of procedure: EU
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L03 Immunomodulators/-stimulants
L03A Immunostimulants
L03AX Other immunostimulants
L03AX14 Histamine dihydrochloride
Shelf life: 36
Container: brown glass vial
Route of admin.: Subcutaneous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 07.10.2008
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 20.09.2022
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