NeuroBloc

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botulinum toxin type B

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for NeuroBloc has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 04/05/2023

Authorisation details

Product details
Name
NeuroBloc
Agency product number
EMEA/H/C/000301
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
Publication details
Marketing-authorisation holder
Sloan Pharma S.a.r.l
Revision
33
Date of issue of marketing authorisation valid throughout the European Union
22/01/2001
Contact address

33 Rue du Puits Romain
8070 Bertrange
Luxembourg

Product information

04/03/2021 NeuroBloc - EMEA/H/C/000301 - IAIN/0107

Other EU languages available icon 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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Muscle relaxants

Therapeutic 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.

Assessment history

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