Code | 5929E | ||||||||||
MA number | EU/1/24/1795/006 | ||||||||||
Product Form: | sus ijp 1x150 mg + 1x100 mg (striek.inj.napl.COC + 2 ihly - zač.liečba) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Neuraxpharm Pharmaceuticals, S.L. , Spain | ||||||||||
Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | pre-filled syringe | ||||||||||
Route of admin.: | Intramuscular use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 21.03.2024 |
Validity: | 21.03.2029 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 10.04.2024 |