Code | 6349E | ||||||||||
MA number | 65/0133/24-S | ||||||||||
Product Form: | tbl plg 56x100 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 |