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PRODUCT DETAIL

DUPHALAC

Code 92030
MA number 61/0141/92-S
Product Form: sir 1x1000 ml (fľ.HDPE)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
MAH, country: Viatris Healthcare Limited, Ireland
Therapeutic Class: 61 - LAXANTIA
ATC:
A ALIMENTARY TRACT AND METABOLISM
A06 DRUGS FOR CONSTIPATION
A06A DRUGS FOR CONSTIPATION
A06AD Osmotically acting laxatives
A06AD11 Lactulose
Shelf life: 36
Container: bottle HDPE
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 17.08.1992
Pediatric indication: Yes
Pediatric posology: Yes
PIL: PIL_DUPHALAC_sir_10_2022.pdf  
SPC: SPC_DUPHALAC_sir_10_2022.pdf  
Safety feature Yes
Data update: 16.01.2018
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