Details

Product Name in the RMS: Folinato de Cálcio Kabi

MR Number: PT/H/1204/001
Date of outcome: 15.10.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	calcium folinate 10 mg/ml
Form	Solution for injection/infusion
MA Holder in the RMS	Fresenius Kabi Deutchland GmbH
RMS	Portugal
Date of last change	28.10.2018
ATC-Code	V03AF03 Calcium folinate

CMS Country	Domestic Product Name
Austria	Calciumfolinat Kabi 10 mg/ml Injektions-/Infusionslösung
Belgium	Folikabi 10 mg/ml, oplossing voor injectie/infusie
Czech Republic	Calcium Folinate Kabi 10 mg/ml, injekční/infuzní roztok
Denmark	Calciumfolinat Fresenius Kabi
Finland
Germany	Calciumfolinat Kabi 10 mg/ml Injektions- oder Infusionslösung
Hungary
Ireland
Luxembourg	Calcium Folinate, Solution injectable/pour perfusion
Malta	Calcium Folinate 10 mg/ml, Solution for Injection or Infusion
Netherlands	Folikabi 10 mg/ml oplossing voor injectie/infusie
Poland	Calcium Folinate Kabi
Romania	Foliat de calciu Kabi 10 mg/ml solutie injectabila/perfuzabila
Spain
United Kingdom

Documents
PAR:	PT_H_1204_001_PAR.pdf (16.12.2015)
Finalised Product Information:	PT_H_1204_001_FinalPI.pdf (15.10.2015)