Oxycodoni hydrochloridum, Naloxoni hydrochloridum

Medicinal product name Oxsynia 40 mg/20 mg prolonged-release tablets
Pharmaceutical form Prolonged-release tablet
Strength 40 mg/20 mg 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.I)
Package leafletPDF 01-08-2023
Summary of product characteristicsPDF 01-08-2023
ATC code N02AA55 Analgesics
Information for Marketing authorisation holdersView

Medicinal products (12)

Availability of medicinal product Wholesalers Package size, content Primary packaging Maximum admissible pharmacy price (€ incl. VAT) Product No. Labelling
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N10
(40 mg/20 mg)
PVC/Al blister    17-0272-01 Labelling text Labelling text May 26, 2020
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N14
(40 mg/20 mg)
PVC/Al blister    17-0272-02 Labelling text Labelling text May 26, 2020
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N20
(40 mg/20 mg)
PVC/Al blister    17-0272-03 Labelling text Labelling text May 26, 2020
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N28
(40 mg/20 mg)
PVC/Al blister    17-0272-04 Labelling text Labelling text May 26, 2020
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N30
(40 mg/20 mg)
PVC/Al blister    17-0272-05 Labelling text Labelling text May 26, 2020
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N50
(40 mg/20 mg)
PVC/Al blister    17-0272-06 Labelling text Labelling text May 26, 2020
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N56
(40 mg/20 mg)
PVC/Al blister    17-0272-07 Labelling text Labelling text May 26, 2020
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N60
(40 mg/20 mg)
PVC/Al blister    17-0272-08 Labelling text Labelling text May 26, 2020
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N98
(40 mg/20 mg)
PVC/Al blister    17-0272-09 Labelling text Labelling text May 26, 2020
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N100
(40 mg/20 mg)
PVC/Al blister    17-0272-10 Labelling text Labelling text May 26, 2020
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N100: 10 × 10
(40 mg/20 mg)
PVC/Al blister    17-0272-11 Labelling text Labelling text May 26, 2020
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N100
(40 mg/20 mg)
HDPE bottle    17-0272-12 Labelling text Labelling text May 26, 2020
Labelling text Labelling text May 26, 2020

Registration information

Marketing authorisation No. 17-0272
MA suspended from the medicinal product register by request of Mundipharma Gesellschaft m.b.H, Austria Sep 15, 2023
Permitted to distribute until Mar 15, 2024
Marketing authorisation holder, country Mundipharma Gesellschaft m.b.H, Austria