Code | 49993 | ||||||||||
MA number | 29/0003/03-S | ||||||||||
Product Form: | tbl flm 5x60 mg (blis.Al/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | N.V. Organon, Netherland | ||||||||||
Therapeutic Class: | 29 - ANTIRHEUMATICA, ANTIPHLOGISTICA, ANTIURATICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 17.01.2003 |
Pediatric indication: | Yes |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_ARCOXIA_01.2024.pdf |
SPC: | SPC_ARCOXIA_01.2024.pdf |
Safety feature | Yes |
Data update: | 12.04.2018 |