- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for NeuroBloc has been withdrawn at the request of the marketing-authorisation holder.
Product information
Latest procedure affecting product information:
IAIN/0107
04/03/2021
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).
Product details
- Name of medicine
- NeuroBloc
- Active substance
- botulinum toxin type B
- International non-proprietary name (INN) or common name
- botulinum toxin type B
- Therapeutic area (MeSH)
- Torticollis
- Anatomical therapeutic chemical (ATC) code
- M03AX01
Pharmacotherapeutic group
Muscle relaxantsTherapeutic indication
NeuroBloc is indicated for the treatment of cervical dystonia (torticollis).
See section 5.1 for data on efficacy in patients responsive / resistant to botulinum toxin type A.
Topics
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