Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1728749
Name of medicinal product: EMPESIN
Active substances:
Estonian, English, Latin
ATC code: H01BA01
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 20RÜ 1ml
Amount in package: 2ml 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Empressin is indicated for the treatment of catecholamine refractory hypotension following septic shock in patients older than 18 years. A catecholamine refractory hypotension is present if the mean arterial blood pressure cannot be stabilised to target despite adequate volume substitution and application of catecholamines (see section 5.1).
Safety features: Yes
Summary of product characteristics (SPC):  (last updated November 26, 2020)
Package information leaflet (PIL): EST  (last updated December 27, 2021)
Labelling:  (last updated April 3, 2018)
Last imported to Estonia: March 27, 2024
Marketing authorization holder: Orpha-Devel Handels und Vertriebs GmbH 
Marketing authorization number: 963118 
Marketing authorization issued on: April 3, 2018 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: December 29, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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