Code | 5057D | ||||||||||
MA number | EU/1/20/1445/001 | ||||||||||
Product Form: | sus inj 20x0,5 ml (liek.inj.skl.) | ||||||||||
MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Janssen - Cilag International N.V., Belgium | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 48 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intramuscular use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 01.07.2020 |
Validity: | 01.07.2025 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 07.07.2020 |