| Code | 9554D | ||||||||||
| MA number | 65/0022/22-S | ||||||||||
| Product Form: | tbl slg 5x1x400 µg (blis.PA/Al/PVC/Al/PET) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | G.L. Pharma GmbH, Austria | ||||||||||
| Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PA/Al/PVC/Al/PET | ||||||||||
| Route of admin.: | Sublingual use |
| Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 18.02.2022 |
| Validity: | 18.02.2027 |
| SPC: |
SPC_Submena_08.2024.pdf
|
| PIL: |
PIL_Submena_08.2024.pdf
|
| Safety feature | Yes |
| Data update: | 23.02.2022 |
