Nyxthracis (previously Obiltoxaximab SFL)
Withdrawn
This medicine's authorisation has been withdrawn
obiltoxaximab
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Nyxthracis has been withdrawn at the request of the marketing-authorisation holder.
Obiltoxaximab SFL : EPAR - Medicine overview
Reference Number: EMA/506632/2020
English (EN) (206.75 KB - PDF)
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български (BG) (269.92 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
español (ES) (205.65 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
čeština (CS) (248.01 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
dansk (DA) (202.61 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
Deutsch (DE) (215.2 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
eesti keel (ET) (196.39 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
ελληνικά (EL) (285.5 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
français (FR) (213.32 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
hrvatski (HR) (240.33 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
italiano (IT) (203.09 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
latviešu valoda (LV) (252.61 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
lietuvių kalba (LT) (244.11 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
magyar (HU) (238.54 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
Malti (MT) (254.15 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
Nederlands (NL) (209.84 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
polski (PL) (244.32 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
português (PT) (205.11 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
română (RO) (243.83 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
slovenčina (SK) (242.26 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
slovenščina (SL) (242.88 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
Suomi (FI) (202.64 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
svenska (SV) (203.15 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
Obiltoxaximab SFL : EPAR - Risk-management-plan summary
English (EN) (143.32 KB - PDF)
First published: Last updated:
Product information
Nyxthracis : EPAR - Product information
English (EN) (1.02 MB - PDF)
First published: Last updated:
български (BG) (1.39 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
español (ES) (1.12 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
čeština (CS) (1.24 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
dansk (DA) (1018.43 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
Deutsch (DE) (1.19 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
eesti keel (ET) (1.09 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
ελληνικά (EL) (1.48 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
français (FR) (1.16 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
hrvatski (HR) (1.3 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
íslenska (IS) (1.02 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
italiano (IT) (1.15 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
latviešu valoda (LV) (1.32 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
lietuvių kalba (LT) (1.33 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
magyar (HU) (1.35 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
Malti (MT) (1.4 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
Nederlands (NL) (1.14 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
norsk (NO) (1.08 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
polski (PL) (1.32 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
português (PT) (1.09 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
română (RO) (1.4 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
slovenčina (SK) (1.26 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
slovenščina (SL) (1.28 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
Suomi (FI) (1.12 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
svenska (SV) (1.08 MB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
Latest procedure affecting product information:
IAIN/0009
14/12/2022
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).
Nyxthracis (previously Obiltoxaximab SFL) : EPAR - All authorised presentations
English (EN) (72.55 KB - PDF)
First published: Last updated:
български (BG) (87.47 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
español (ES) (75.03 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
čeština (CS) (78.26 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
dansk (DA) (75.56 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
Deutsch (DE) (77.09 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
eesti keel (ET) (70.97 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
ελληνικά (EL) (82.14 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
français (FR) (73.97 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
hrvatski (HR) (75.81 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
íslenska (IS) (77.57 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
italiano (IT) (74.85 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
latviešu valoda (LV) (79.66 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
lietuvių kalba (LT) (78.16 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
magyar (HU) (77.6 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
Malti (MT) (81.82 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
Nederlands (NL) (73.07 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
norsk (NO) (80.13 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
polski (PL) (79.97 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
português (PT) (76.77 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
română (RO) (77.29 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
slovenčina (SK) (79.86 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
slovenščina (SL) (76.2 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
Suomi (FI) (70.89 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
svenska (SV) (73.9 KB - PDF)
First published: 27/11/2020Last updated: 09/09/2024
Product details
- Name of medicine
- Nyxthracis (previously Obiltoxaximab SFL)
- Active substance
- nyxthracis
- International non-proprietary name (INN) or common name
- obiltoxaximab
- Therapeutic area (MeSH)
- Anthrax
- Anatomical therapeutic chemical (ATC) code
- J06BB22
Pharmacotherapeutic group
Immune sera and immunoglobulinsTherapeutic indication
Obiltoxaximab SFL is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to Bacillus anthracis (see section 5.1).
Obiltoxaximab SFL is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.1).
Authorisation details
- EMA product number
- EMEA/H/C/005169
Exceptional circumstances
This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.
Orphan
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
- Marketing authorisation holder
- SFL Pharmaceuticals Deutschland GmbH
SFL Pharmaceuticals Deutschland GmbH
Marie-Curie-Strasse 8
79539 Lörrach
Germany - Opinion adopted
- 17/09/2020
- Marketing authorisation issued
- 18/11/2020
- Revision
- 3
Assessment history
Nyxthracis (previously Obiltoxaximab SFL) : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (349.54 KB - PDF)
First published: Last updated:
Obiltoxaximab SFL : EPAR - Public assessment report
AdoptedReference Number: EMA/524933/2020
English (EN) (7.89 MB - PDF)
First published: Last updated:
Obiltoxaximab SFL : Orphan maintenance assessment report (initial authorisation)
AdoptedReference Number: EMA/OD/0000037218
English (EN) (592.6 KB - PDF)
First published: Last updated:
CHMP summary of positive opinion for Obiltoxaximab SFL
AdoptedReference Number: EMA/CHMP/460994/2020
English (EN) (226.26 KB - PDF)
First published: Last updated:
News on Nyxthracis (previously Obiltoxaximab SFL)
More information on Nyxthracis
Public statement on Nyxthracis : Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/385873/2024
English (EN) (94.43 KB - PDF)
First published:
More information on Nyxthracis (previously Obiltoxaximab SFL)
Topics
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