Oxycodoni hydrochloridum, Naloxoni hydrochloridum

Medicinal product name Oxsynia 10 mg/5 mg prolonged-release tablets
Pharmaceutical form Prolonged-release tablet
Strength 10 mg/5 mg 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.I)
Package leafletMS Word document 08-07-2021
Summary of product characteristicsMS Word document 08-07-2021
ATC code N02AA55 Analgesics

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
(10 mg/5 mg)
PVC/Al blister    17-0268-01 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
(10 mg/5 mg)
PVC/Al blister    17-0268-02 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
(10 mg/5 mg)
PVC/Al blister    17-0268-03 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
(10 mg/5 mg)
PVC/Al blister    17-0268-04 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
(10 mg/5 mg)
PVC/Al blister    17-0268-05 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
(10 mg/5 mg)
PVC/Al blister    17-0268-06 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
(10 mg/5 mg)
PVC/Al blister    17-0268-07 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
(10 mg/5 mg)
PVC/Al blister    17-0268-08 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
(10 mg/5 mg)
PVC/Al blister    17-0268-09 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
(10 mg/5 mg)
PVC/Al blister    17-0268-10 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
(10 mg/5 mg)
PVC/Al blister    17-0268-11 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
(10 mg/5 mg)
HDPE bottle    17-0268-12 Labelling text Labelling text May 26, 2020
Labelling text Labelling text May 26, 2020

Registration information

Marketing authorisation No. 17-0268
Date of authorisation Dec 22, 2017
MA valid until For unlimited time
Marketing authorisation holder, country Mundipharma Gesellschaft m.b.H, Austria