Sustiva
Withdrawn
This medicine's authorisation has been withdrawn
efavirenz
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Sustiva has been withdrawn at the request of the marketing-authorisation holder.
Sustiva : EPAR - Summary for the public
English (EN) (182.37 KB - PDF)
First published: Last updated:
български (BG) (258.97 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
español (ES) (182.72 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
čeština (CS) (233.12 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
dansk (DA) (182.24 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
Deutsch (DE) (193.92 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
eesti keel (ET) (174.51 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
ελληνικά (EL) (267.72 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
français (FR) (190.13 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
hrvatski (HR) (225.5 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
italiano (IT) (182.03 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
latviešu valoda (LV) (231.22 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
lietuvių kalba (LT) (231.23 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
magyar (HU) (218.78 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
Malti (MT) (236.46 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
Nederlands (NL) (187.4 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
polski (PL) (234.35 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
português (PT) (185.1 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
română (RO) (239.14 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
slovenčina (SK) (228.61 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
slovenščina (SL) (218.25 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
Suomi (FI) (176.01 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
svenska (SV) (181.1 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
Product information
Sustiva : EPAR - Product Information
English (EN) (5.86 MB - PDF)
First published: Last updated:
български (BG) (17.63 MB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
español (ES) (6.36 MB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
čeština (CS) (14.64 MB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
dansk (DA) (5.99 MB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
Deutsch (DE) (7.34 MB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
eesti keel (ET) (5.79 MB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
ελληνικά (EL) (19.02 MB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
français (FR) (6.46 MB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
hrvatski (HR) (11.79 MB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
íslenska (IS) (5.93 MB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
italiano (IT) (82.01 KB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
latviešu valoda (LV) (100.85 KB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
lietuvių kalba (LT) (101.06 KB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
magyar (HU) (11.05 MB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
Malti (MT) (101.59 KB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
Nederlands (NL) (83.32 KB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
norsk (NO) (5.92 MB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
polski (PL) (100.82 KB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
português (PT) (82.47 KB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
română (RO) (95.5 KB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
slovenčina (SK) (96.27 KB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
slovenščina (SL) (90.6 KB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
Suomi (FI) (6.21 MB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
svenska (SV) (82.81 KB - PDF)
First published: 16/11/2009Last updated: 14/03/2024
Latest procedure affecting product information:
N/0161
23/05/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Sustiva : EPAR - All Authorised presentations
English (EN) (82.79 KB - PDF)
First published: Last updated:
български (BG) (106.92 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
español (ES) (82.95 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
čeština (CS) (91.71 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
dansk (DA) (83.65 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
Deutsch (DE) (84.27 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
eesti keel (ET) (83.76 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
ελληνικά (EL) (98.05 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
français (FR) (83.23 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
hrvatski (HR) (98.88 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
íslenska (IS) (83.88 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
italiano (IT) (82.01 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
latviešu valoda (LV) (100.85 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
lietuvių kalba (LT) (101.06 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
magyar (HU) (101.33 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
Malti (MT) (101.59 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
Nederlands (NL) (83.32 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
norsk (NO) (83.73 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
polski (PL) (100.82 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
português (PT) (82.47 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
română (RO) (95.5 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
slovenčina (SK) (96.27 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
slovenščina (SL) (90.6 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
Suomi (FI) (81.93 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
svenska (SV) (82.81 KB - PDF)
First published: 30/04/2009Last updated: 14/03/2024
Product details
- Name of medicine
- Sustiva
- Active substance
- efavirenz
- International non-proprietary name (INN) or common name
- efavirenz
- Therapeutic area (MeSH)
- HIV Infections
- Anatomical therapeutic chemical (ATC) code
- J05AG03
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Sustiva is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older.
Sustiva has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Sustiva.
Authorisation details
- EMA product number
- EMEA/H/C/000249
- Marketing authorisation holder
- Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland - Marketing authorisation issued
- 28/05/1999
- Revision
- 48
Assessment history
Sustiva : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (1.56 MB - PDF)
First published: Last updated:
Sustiva-H-C-PSUSA-00001200-201804 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Reference Number: EMA/132484/2019
English (EN) (116.29 KB - PDF)
First published: Last updated:
Sustiva-H-C-249-II-0126-G : EPAR - Scientific Discussion - Variation
AdoptedReference Number: EMA/260283/2015
English (EN) (4.13 MB - PDF)
First published: Last updated:
CHMP post-authorisation summary of positive opinion for Sustiva
AdoptedReference Number: EMA/CHMP/104007/2015
English (EN) (103.24 KB - PDF)
First published: Last updated:
Sustiva-H-C-249-P45-0056: EPAR - Assessment Report
AdoptedReference Number: EMA/815692/2012
English (EN) (187.48 KB - PDF)
First published: Last updated:
Sustiva : EPAR - Steps taken after authorisation when a cutoff date has been used
English (EN) (263.13 KB - PDF)
First published: Last updated:
News on Sustiva
More information on Sustiva
Public statement on Sustiva: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/576905/2023
English (EN) (115.51 KB - PDF)
First published:
Topics
This page was last updated on