Product Name in the RMS: Rosuvastatin/omega-3-acid ethyl esters 90, 5 mg/1000 mg soft capsules
MR Number: NL/H/4611/001
Date of outcome: 15.01.2020
| Type of application | |
|---|---|
|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Known Active Substance Initial Application Fixed Combination Chemical Substance Prescription Only |
| Active Substances |
omega-3-acid ethyl esters 1000 mg rosuvastatin calcium 5 mg |
| Form | Capsule, soft |
| MA Holder in the RMS |
Oy Medfiles Ltd Volttikatu 5 70700 Kuopio Finland |
| RMS | Netherlands |
| Date of last change | 20.08.2020 |
| ATC-Code |
C10B LIPID MODIFYING AGENTS, COMBINATIONS |
| CMS Country | Domestic Product Name |
|---|---|
| Italy |
| Documents | |
|---|---|
| PAR: | NL_H_4611_001_PAR.pdf (29.07.2020) |
| PARSummary: | NL_H_4611_001_PARSummary.pdf (29.07.2020) |
| FinalLabelling: | NL_H_4611_001_FinalLabelling_1of3.pdf (15.01.2020) |
| FinalLabelling: | NL_H_4611_001_FinalLabelling_2of3.pdf (15.01.2020) |
| FinalLabelling: | NL_H_4611_001_FinalLabelling_3of3.pdf (15.01.2020) |