| Code | 6357E | ||||||||||
| MA number | 65/0134/24-S | ||||||||||
| Product Form: | tbl plg 24x150 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | MEDOCHEMIE Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PE/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 09.07.2024 |
| Validity: | 09.07.2029 |
| SPC: |
SPC_DOLTEN RETARD_06.2024.pdf
|
| PIL: |
PIL_DOLTEN RETARD_06.2024.pdf
|
| Safety feature | Yes |
| Data update: | 15.07.2024 |
