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PRODUCT DETAIL

Dropizol 10 mg/ml

Code 8919C
MA number 49/0251/18-S
Product Form: gto por 10x10 ml (fľ.skl.hnedá)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
Therapeutic Class: 49 - DIGESTIVA, ADSORBENTIA, ACIDA
ATC:
A ALIMENTARY TRACT AND METABOLISM
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/INTESTINAL ANTIINFECTIVES
A07D ANTIPROPULSIVES
A07DA Antipropulsives
A07DA02 Opium
Shelf life: 36
Container: brown glass bottle
Route of admin.: Oral use
Prescription Status: Medicinal product subject to special medical prescription with skew blue stripe.
Legal basis: Article 10a well-established use application
MA issued: 12.09.2018
Validity: 12.09.2023
MA renewed: Renewal application submitted
SPC: SPC_Dropizol 10 mg_ml_gto por_08_2019.doc  
PIL: PIL_Dropizol 10 mg_ml_gto por_08_2019.doc  
Safety feature Yes
Data update: 26.08.2019
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