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PRODUCT DETAIL

Zemcelpro

Code 1162F
MA number EU/1/25/1960/001
Product Form: dis inf 8x20 ml (vak EVA)
MA Status: Ex - Conditional centralised marketing authorisation
Type of procedure: EU Orphan
MAH, country: Cordex Biologics International Limited, Ireland
Therapeutic Class: 75 - SUBSTITUTIO SANGUINIS (A KRVNÉ DERIVÁTY)
ATC:
B BLOOD AND BLOOD FORMING ORGANS
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B05A BLOOD AND RELATED PRODUCTS
B05AX Other blood products
B05AX04 Stem cells from umbilical cord blood
Shelf life: 12
Container: bag ethylene vinyl acetate (EVA)
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 25.08.2025
Validity: 25.08.2026
Safety feature No
Data update: 17.09.2025
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