Orbactiv

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oritavancin

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Orbactiv. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Orbactiv.

For practical information about using Orbactiv, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 07/02/2019

Authorisation details

Product details
Name
Orbactiv
Agency product number
EMEA/H/C/003785
Active substance
oritavancin diphosphate
International non-proprietary name (INN) or common name
oritavancin
Therapeutic area (MeSH)
  • Soft Tissue Infections
  • Skin Diseases, Bacterial
Anatomical therapeutic chemical (ATC) code
J01XA05
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Menarini International Operations Luxembourg S.A.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
18/03/2015
Contact address

1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg

Product information

11/01/2019 Orbactiv - EMEA/H/C/003785 - T/0022

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Orbactiv is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Assessment history

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