| Medicinal product name | Agomelatine Mylan 25 mg film-coated tablets |
|---|---|
| Pharmaceutical form | Film-coated tablet |
| Strength | 25 mg |
| Information from the MAH on shortages |
Not available predicted availability date: Sep 1, 2025 |
| Legal status | Prescription (Pr.) |
| Summary of product characteristics |  14-09-2021
|
| Package leaflet |  29-09-2022
|
| Risk minimisation measures | Izglītojošie materiāli ārstam Izglītojošie materiāli pacientam |
| ATC code | N06AX22 – Psychoanaleptics |
| 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 |
|---|---|---|---|---|---|---|
| Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N7 (25 mg) |
OPA/Al/PVC/Al blister | 18-0130-01 |
Labelling text Sep 14, 2021 |
|
| Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N14 (25 mg) |
OPA/Al/PVC/Al blister | 18-0130-02 |
Labelling text Sep 14, 2021 |
|
|
Not available (according to the information provided by wholesalers) predicted availability date: Sep 1, 2025 |
currently no information on availability from any wholesaler |
N28 (25 mg) |
OPA/Al/PVC/Al blister | € 28.43 | 18-0130-03 |
Labelling text Sep 14, 2021 |
| Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N42 (25 mg) |
OPA/Al/PVC/Al blister | 18-0130-04 |
Labelling text Sep 14, 2021 |
|
| Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N56 (25 mg) |
OPA/Al/PVC/Al blister | 18-0130-05 |
Labelling text Sep 14, 2021 |
|
| Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N84 (25 mg) |
OPA/Al/PVC/Al blister | 18-0130-06 |
Labelling text Sep 14, 2021 |
|
| Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N98 (25 mg) |
OPA/Al/PVC/Al blister | 18-0130-07 |
Labelling text Sep 14, 2021 |
|
| Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N100 (25 mg) |
OPA/Al/PVC/Al blister | 18-0130-08 |
Labelling text Sep 14, 2021 |
Registration information
| Marketing authorisation No. | 18-0130 |
|---|---|
| Date of authorisation | Sep 4, 2018 |
| Marketing authorisation holder, country | Mylan Pharmaceuticals Limited, Ireland |
