NeuroBloc

Withdrawn

This medicine's authorisation has been withdrawn

botulinum toxin type B

Overview

The marketing authorisation for NeuroBloc has been withdrawn at the request of the marketing-authorisation holder.

NeuroBloc : EPAR - Summary for the public

Product information

NeuroBloc : EPAR - 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).

NeuroBloc : EPAR - All Authorised presentations

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 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.

Authorisation details

• EMA product number:
  EMEA/H/C/000301
• Marketing authorisation holder:
  Sloan Pharma S.a.r.l

  33 Rue du Puits Romain; 8070 Bertrange; Luxembourg

• Opinion adopted:
  19/10/2000
• Marketing authorisation issued:
  22/01/2001
• Revision:
  33

Assessment history

Changes since initial authorisation of medicine

NeuroBloc : EPAR - Procedural steps taken and scientific information after authorisation

NeuroBloc-H-C-PSUSA-00000428-201706 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Adopted

NeuroBloc : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

NeuroBloc : EPAR - Procedural steps taken before authorisation

NeuroBloc : EPAR - Scientific Discussion