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50MG/850MG TBL FLM 168 I

SPC - Summary of product characteristics sipactimet-spc.pdf
NR - Registration decision NR6136721.pdf
PIL - Package leaflet sipactimet-pil.pdf
PAR - Public assessment report  
Text on the wrap sipactimet-obal.pdf
Braills Approved – name of the medicinal product in Braille on the packaging was confirmed.
SPCs and PILs of centralised medicinal products (registration number beginning EU) are included as a link to website of the European Medicines Agency (EMEA) Information is available on this website in section Product Information. Please note that the texts refer to all strenghts and pharmaceutical forms of the given medicinal product. SUKL is not responsible for update SPCs and PILs on EMEA web site.

EAN – more specific information about EAN code is available in the Overview

I - neregistrovaný léčivý přípravek jehož distribuce, výdej a použití je umožněno na základě opatření Ministerstva zdravotnictví ČR podle § 8 odst. 6 zákona o léčivech.

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