IE
IE · IE · IE-PA-EU/1/20/1457/002
Xenleta 600 mg film-coated tablets
ATC J01XX12
Last synced from HPRA (Ireland) on
Identification
ManufacturerNabriva Therapeutics Ireland Designated Activity Company
CountryIE (IE)
ATC codeJ01XX12
Dispensing—
ReimbursedNo
SourceHPRA (Ireland)
Last synced6/15/2026
Packs · 1
- ie_pa_numberEU/1/20/1457/002
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Raw payload (JSON)
{
"form": "Film-coated tablet",
"routes": [
"Intravenous use",
"Oral use"
],
"source": "hpra",
"atc_all": [
"J01XX",
"J01XX12"
],
"strength": null,
"pa_number": "EU/1/20/1457/002",
"substances": [
"Lefamulin"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "27/07/2020",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}Related drugs
Other records sharing ATC code J01XX12.
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