Details
Product Name in the RMS: Zigilex ODT
MR Number: PL/H/0590/001
Date of outcome: 22.07.2015
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Known Active Substance Initial Application Generic Chemical Substance Prescription Only |
Active Substances |
azithromycin 20 mg |
Form | Orodispersible tablet |
MA Holder in the RMS |
PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 170 00 Prague 7 Czech Republic |
RMS | Poland |
Date of last change | 11.08.2019 |
ATC-Code |
J01FA10 Azithromycin |
CMS Country | Domestic Product Name |
---|---|
Slovak Republic |
Documents | |
---|---|
PAR: | PL_H_0590_001_PAR.pdf (02.03.2016) |
PARSummary: | PL_H_0590_001_PARSummary.pdf (02.03.2016) |
FinalSPC: | PL_H_0590_001_FinalSPC.pdf (04.07.2018) |
FinalPL: | PL_H_0590_001_FinalPL.pdf (04.07.2018) |
FinalLabelling: | PL_H_0590_001_FinalLabelling.pdf (04.08.2015) |