Oxycodoni hydrochloridum, Naloxoni hydrochloridum

Medicinal product name Oxsynia 5 mg/2.5 mg prolonged-release tablets
Pharmaceutical form Prolonged-release tablet
Strength 5 mg/2.5 mg 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.I)
Summary of product characteristicsPDF 23-02-2023
Package leafletPDF 28-12-2022
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
(5 mg/2,5 mg)
PVC/Al blister    17-0267-01 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
(5 mg/2,5 mg)
PVC/Al blister    17-0267-02 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
(5 mg/2,5 mg)
PVC/Al blister    17-0267-03 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
(5 mg/2,5 mg)
PVC/Al blister    17-0267-04 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
(5 mg/2,5 mg)
PVC/Al blister    17-0267-05 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
(5 mg/2,5 mg)
PVC/Al blister    17-0267-06 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
(5 mg/2,5 mg)
PVC/Al blister    17-0267-07 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
(5 mg/2,5 mg)
PVC/Al blister    17-0267-08 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
(5 mg/2,5 mg)
PVC/Al blister    17-0267-09 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
(5 mg/2,5 mg)
PVC/Al blister    17-0267-10 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
(5 mg/2,5 mg)
PVC/Al blister    17-0267-11 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
(5 mg/2,5 mg)
HDPE bottle    17-0267-12 Labelling text Labelling text May 26, 2020
Labelling text Labelling text May 26, 2020

Registration information

Marketing authorisation No. 17-0267
Date of authorisation Dec 22, 2017
Marketing authorisation holder, country Mundipharma Gesellschaft m.b.H, Austria