Medicinal Products

Awardix 100 mg otopina za injekciju/infuziju

Name Awardix 100 mg otopina za injekciju/infuziju
Marketing Authorisation Number HR-H-840360429
Active Substance tramadolklorid
Composition 2 ml otopine za injekciju/infuziju (1 ampula) sadrži 100 mg tramadolklorida 1 ml otopine za injekciju/infuziju sadrži 50 mg tramadolklorida
Pharmaceutical Form Otopina za injekciju / infuziju
Manufacturer Krka d.d., Novo mesto, Novo Mesto, Slovenija
TAD Pharma Gmbh, Cuxhaven, Njemačka
Marketing Authorisation Holder Krka d.d., Novo mesto, Šmarješka cesta 6, Novo Mesto, Slovenija
Marketing Authorisation Date 26.07.2022
MA Period of Validity unlimited
Classification Number UP/I-530-09/22-02/27
Registration Number 381-12-01/70-22-03
Prescription Medicinal product subject to medical prescription
Type of prescription Medicinal product subject to restricted medical prescription
Distribution Supply through pharmacies (community)
Advertising to general public not allowed
ATC Code N02AX02
Marketing status Never marketed
SmPC download
PL download
Public Assessment Report download

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