NeuroBloc

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botulinum toxin type B

Authorised
This medicine is authorised for use in the European Union.

Overview

NeuroBloc is a medicine used to treat cervical dystonia in adults. Cervical dystonia, which is also known as torticollis, is a disorder when the neck muscles contract, causing abnormal movement and twisting of the neck and unusual positioning of the head.

NeuroBloc contains the active substance botulinum toxin type B.

This EPAR was last updated on 05/10/2018

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
30
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

05/10/2018 NeuroBloc - EMEA/H/C/000301 - T/0101

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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