Code | 3614E | ||||||||||
MA number | 29/0115/23-S | ||||||||||
Product Form: | tbl 50x0,5 mg (blis.PVC/PVDC/Al | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
Therapeutic Class: | 29 - ANTIRHEUMATICA, ANTIPHLOGISTICA, ANTIURATICA | ||||||||||
ATC: |
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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 |