Details
Product Name in the RMS: Valganciclovir Sandoz 450 mg
MR Number: NL/H/3010/001
Date of outcome: 10.11.2014
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Initial Application Generic Chemical Substance Prescription Only |
Active Substances |
valganciclovir hydrochloride 450 mg |
Form | Film-coated tablet |
MA Holder in the RMS |
Sandoz B.V. Veluwezoom 22 1327 AH Almere The Netherlands |
RMS | Netherlands |
Date of last change | 26.01.2019 |
ATC-Code |
J05AB14 Valganciclovir |
CMS Country | Domestic Product Name |
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Austria | Valganciclovir Sandoz 450 mg - Filmtabletten |
Belgium | Valganciclovir Sandoz 450mg filmomhulde tabletten |
Cyprus | VALGANCICLOVIR HLC SANDOZ TABS |
Czech Republic | Valganciclovir Sandoz 450 mg potahované tablety |
Denmark | |
Estonia | VALGANCICLOVIR SANDOZ |
Finland | |
France | |
Germany | Valganciclovir HEXAL 450 mg filmtabletten |
Ireland | |
Italy | |
Latvia | Valganciclovir Sandoz 450 mg apvalkotās tabletes |
Lithuania | Valganociclovir Sandoz 450 mg plėvele dengtos tabletės |
Luxembourg | |
Norway | Valganciclovir Sandoz |
Poland | Ceglar |
Portugal | |
Romania | VALGANCICLOVIR SANDOZ 450 mg comprimate filmate |
Slovenia | |
Spain | |
Sweden | |
United Kingdom |
Documents | |
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PAR: | NL_H_3010_001_PAR.pdf (18.03.2015) |
PARSummary: | NL_H_3010_001_PARSummary.pdf (18.03.2015) |
FinalLabelling: | NL_H_3010_001_FinalLabelling_1of3.pdf (25.10.2018) |
FinalLabelling: | NL_H_3010_001_FinalLabelling_2of3.pdf (25.10.2018) |
FinalLabelling: | NL_H_3010_001_FinalLabelling_3of3.pdf (25.10.2018) |