NeuroBloc

Withdrawn

This medicine's authorisation has been withdrawn

botulinum toxin type B

Overview

On 9 December 2022, the European Commission withdrew the marketing authorisation for NeuroBloc (botulinum toxin type B) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Sloan Pharma S.a.r.l, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

NeuroBloc was granted marketing authorisation in the EU on 22 January 2001 for the treatment of cervical dystonia in adults. Therapeutic alternatives are available throughout the European Union. Patients taking Neurobloc or participating in a clinical trial are advised to consult their physician. 

The European Public Assessment Report (EPAR) for NeuroBloc (SRD) is updated to indicate that the marketing authorisation is no longer valid.

NeuroBloc : EPAR - Summary for the public

Product information

NeuroBloc : EPAR - Product Information

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