Details
Product Name in the RMS: Vesicare 1 mg/ml oral suspension
MR Number: NL/H/0487/003
Date of outcome: 10.08.2015
Type of application | |
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Level 1: Level 2: Level 3: Level 4: Level 5: |
Known Active Substance Initial Application Full Dossier Chemical Substance Prescription Only |
Active Substances |
solifenacin succinate 1 mg/ml |
Form | Oral suspension |
MA Holder in the RMS |
Astellas Pharma Europe BV Sylviusweg 62 2333 BE Leiden The Netherlands |
RMS | Netherlands |
Date of last change | 04.12.2020 |
ATC-Code |
G04BD08 Solifenacin |
CMS Country | Domestic Product Name |
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Austria | Vesicare 1 mg/ml Suspension zum Einnehmen |
Belgium | Vesicare 1mg/ml suspensie voor oraal gebruik/ suspension buvable /Suspension zum Einnehmen |
Bulgaria | Vesicare |
Croatia | Vesicare 1 mg/ml oralna suspenzija |
Cyprus | VESICARE ORAL SUSPENSION 1MG/ML |
Czech Republic | VESICARE 1 MG/ML PERORÁLNÍ SUSPENZE |
Denmark | Vesicare |
Estonia | VESICARE |
Finland | |
France | |
Germany | Vesikur 1 mg/ml Suspension zum Einnehmen |
Greece | VESICARE |
Hungary | VESICARE 1 mg/ml belsőleges szuszpenzió |
Iceland | Vesicare 1 mg/ml Mixtúra, dreifa |
Ireland | |
Italy | |
Latvia | Vesicare 1 mg/ml suspensija iekšķīgai lietošanai |
Liechtenstein | |
Lithuania | Vesicare 1 mg/ml geriamoji suspensija |
Luxembourg | |
Malta | Vesicare 1 mg/ml oral suspension |
Norway | Vesicare |
Poland | Vesicare |
Portugal | |
Romania | Vesicare 1 mg/ml suspensie orală |
Slovak Republic | Vesicare 1 mg/ml perorálna suspenzia |
Slovenia | Vesicare 1mg/ml peroralna suspenzija |
Spain | |
Sweden | |
United Kingdom |
Documents | |
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PAR: | NL_H_0487_003_PAR.pdf (31.10.2016) |
PARSummary: | NL_H_0487_003_PARSummary.pdf (31.10.2016) |
FinalSPC: | NL_H_0487_003_FinalSPC.pdf (23.10.2019) |
FinalPL: | NL_H_0487_003_FinalPL.pdf (23.10.2019) |
FinalLabelling: | NL_H_0487_003_FinalLabelling.pdf (23.10.2019) |