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: |
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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 |