| Code | 3615E | ||||||||||
| MA number | 29/0115/23-S | ||||||||||
| Product Form: | tbl 60x0,5 mg (blis.PVC/PVDC/Al | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| Therapeutic Class: | 29 - ANTIRHEUMATICA, ANTIPHLOGISTICA, ANTIURATICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 22.06.2023 |
| Validity: | 22.06.2028 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Colcamedin 0,5 mg tablety_05_2023.pdf
|
| PIL: |
PIL_Colcamedin 0,5 mg tablety_12.2023.pdf
|
| Safety feature | Yes |
| Data update: | 28.06.2023 |
