Latest hum. ProductsDetails
Product Name in the RMS: Intestat
MR Number: DK/H/2444/001
Date of outcome: 18.11.2015
| Type of application | |
|---|---|
|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Initial Application Generic Chemical Substance Prescription Only |
| Active Substances |
ezetimibe 10 mg |
| Form | Tablet |
| MA Holder in the RMS |
Gedeon Richter Plc. Gyömrői út 19-21 1103 Budapest Hungary |
| RMS | Denmark |
| Date of last change | 14.05.2019 |
| ATC-Code |
C10AX09 Ezetimib |
| CMS Country | Domestic Product Name |
|---|---|
| Czech Republic | Coltowan 10 mg tablety |
| Hungary | |
| Latvia | Coltowan 10 mg tabletes |
| Poland |
| Documents | |
|---|---|
| PAR: | DK_H_2444_001_PAR.pdf (05.01.2016) |
| PARSummary: | DK_H_2444_001_PARSummary.pdf (05.01.2016) |
| FinalSPC: | DK_H_2444_001_FinalSPC.pdf (22.02.2018) |
| FinalPL: | DK_H_2444_001_FinalPL.pdf (10.01.2018) |
| FinalLabelling: | DK_H_2444_001_FinalLabelling.pdf (10.01.2018) |
