Latest hum. ProductsDetails
Product Name in the RMS: Zigilex ODT
MR Number: PL/H/0590/002
Date of outcome: 22.07.2015
| Type of application | |
|---|---|
|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Known Active Substance Additional Strength/Form Generic Chemical Substance Prescription Only |
| Active Substances |
azithromycin 100 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 | 14.01.2019 |
| ATC-Code |
J01FA10 Azithromycin |
| CMS Country | Domestic Product Name |
|---|---|
| Denmark | Zigilex ODT |
| Slovak Republic |
| Documents | |
|---|---|
| PAR: | PL_H_0590_002_PAR.pdf (02.03.2016) |
| PARSummary: | PL_H_0590_002_PARSummary.pdf (02.03.2016) |
| FinalSPC: | PL_H_0590_002_FinalSPC.pdf (04.07.2018) |
| FinalPL: | PL_H_0590_002_FinalPL.pdf (04.07.2018) |
| FinalLabelling: | PL_H_0590_002_FinalLabelling.pdf (04.08.2015) |
