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PRODUCT DETAIL

Malarone

Code 97767
MA number 25/0127/06-S
Product Form: tbl flm 12x250 mg/100 mg (blis.PVC/Al/papier-bezpeč.bal.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
Therapeutic Class: 25 - ANTIPARASITICA (ANTIPROTOZOICA, ANTIMALARICA)
ATC:
P ANTIPARASITIC PRODUCTS
P01 ANTIPROTOZOALS
P01B ANTIMALARIALS
P01BB Biguanides
P01BB51 Proguanil, combinations
Shelf life: 60
Container: blister PVC/Al/ paper
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10b fixed combination application
MA issued: 10.03.2006
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_Malarone tbl flm_ januar2021.docx  
PIL: PIL_Malarone_tbl flm_02_2022.pdf  
Safety feature Yes
Data update: 23.07.2018
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