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PRODUCT DETAIL

ROMLA 25 mg/g + 25 mg/g krém

Code 3113D
MA number 01/0390/19-S
Product Form: crm 5x5 g (tuba Al+12 okluzív.krytí)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Decentralised
Therapeutic Class: 01 - ANAESTHETICA (LOKÁLNE)
ATC:
N NERVOUS SYSTEM
N01 ANESTHETICS
N01B ANESTHETICS, LOCAL
N01BB Amides
N01BB20 Amides, combinations
Shelf life: 30
Container: tube Al
Route of admin.: Cutaneous use
Prescription Status: Medicinal product not subject to medical prescription.
Legal basis: Article 10(3) hybrid application
MA issued: 18.12.2019
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_ROMLA_11_2021.pdf  
PIL: PIL_ROMLA_11_2021.pdf  
Safety feature No
Data update: 23.09.2021
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