Buprenorphinum, Naloxonum
Medicinal product name | Bupensanduo 4 mg/1 mg sublingual tablets |
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Pharmaceutical form | Sublingual tablet |
Strength | 4 mg/1 mg |
Information from the MAH on shortages | No information on expected shortages |
Legal status | Prescription (Pr.I, Pr.II nark.) |
Package leaflet | 20-04-2023 |
Summary of product characteristics | 20-04-2023 |
ATC code | N07BC51 – Other nervous system drugs |
Information for Marketing authorisation holders | View |
Medicinal products (8)
Availability of medicinal product | Wholesalers | Package size, content | Primary packaging | Maximum admissible pharmacy price (€ incl. VAT) | Product No. | Labelling |
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Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N7 (4 mg/1 mg) |
OPA/Al/PVC/Al blister | € 24.00 | 18-0091-01 |
Labelling text Apr 20, 2023 Labelling text Apr 20, 2023 |
Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N28 (4 mg/1 mg) |
OPA/Al/PVC/Al blister | 18-0091-02 |
Labelling text Apr 20, 2023 Labelling text Apr 20, 2023 |
|
Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N49 (4 mg/1 mg) |
OPA/Al/PVC/Al blister | 18-0091-03 |
Labelling text Apr 20, 2023 Labelling text Apr 20, 2023 |
|
Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N56 (4 mg/1 mg) |
OPA/Al/PVC/Al blister | 18-0091-04 |
Labelling text Apr 20, 2023 Labelling text Apr 20, 2023 |
|
Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N7: 7 × 1 (4 mg/1 mg) |
OPA/Al/PVC/Al unit-dose blister | 18-0091-05 |
Labelling text Apr 20, 2023 Labelling text Apr 20, 2023 |
|
Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N28: 28 × 1 (4 mg/1 mg) |
OPA/Al/PVC/Al unit-dose blister | 18-0091-06 |
Labelling text Apr 20, 2023 Labelling text Apr 20, 2023 |
|
Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N49: 49 × 1 (4 mg/1 mg) |
OPA/Al/PVC/Al unit-dose blister | 18-0091-07 |
Labelling text Apr 20, 2023 Labelling text Apr 20, 2023 |
|
Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N56: 56 × 1 (4 mg/1 mg) |
OPA/Al/PVC/Al unit-dose blister | 18-0091-08 |
Labelling text Apr 20, 2023 Labelling text Apr 20, 2023 |
Registration information
Marketing authorisation No. | 18-0091 |
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Date of authorisation | Jun 5, 2018 |
Marketing authorisation holder, country | G.L. Pharma GmbH, Austria |