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PRODUCT DETAIL

Omarit

Code 04077
MA number 24/0912/10-S
Product Form: tbl 40x20 mg (blis.PA/Al/PVC/Al)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Decentralised
Therapeutic Class: 24 - ANTIHISTAMINICA, HISTAMIN
ATC:
R RESPIRATORY SYSTEM
R06 ANTIHISTAMINES FOR SYSTEMIC USE
R06A ANTIHISTAMINES FOR SYSTEMIC USE
R06AX Other antihistamines for systemic use
R06AX29 Bilastine
Shelf life: 60
Container: blister PA/Al/PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 25.01.2011
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_Omarit_05.2021.pdf  
PIL: PIL_Omarit_OTC_03.2024.pdf  
PIL: PIL_Omarit_Rx_03.2024.pdf  
Safety feature Yes
Data update: 09.03.2018
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