NEUROBLOC Solution for injection

Active ingredients: Botulinum toxin type B

Product name and form

NeuroBloc 5000 U/ml solution for injection.

Pharmaceutical Form

Solution for injection.

Clear and colourless to light yellow solution.

Qualitative and quantitative composition

Each ml contains 5000 U Botulinum Toxin Type B.

Each 0.5 ml vial contains 2500 U Botulinum Toxin Type B.
Each 1.0 ml vial contains 5000 U Botulinum Toxin Type B.
Each 2.0 ml vial contains 10,000 U Botulinum Toxin Type B.

Produced in Clostridium botulinum Serotype B (Bean Strain) cells.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Botulinum toxin type B is a neuromuscular blocking agent indicated for the treatment of cervical dystonia. When injected directly into a muscle, it causes a localised paralysis that gradually reverses over time.

List of Excipients

Disodium succinate
Sodium chloride
Human serum albumin
Hydrochloric acid (for pH adjustment)
Water for injections

Pack sizes and marketing

0.5 ml, 1 ml or 2 ml solution in a 3.5 ml Type I glass vial, with siliconised butyl rubber stoppers oversealed by aluminium crimped caps.

Pack size of 1.

Marketing authorization holder

Sloan Pharma S.à.r.l., 33, Rue du Puits Romain, 8070 Bertrange, Luxembourg

Marketing authorization dates and numbers

EU/1/00/166/001 – 2500 U
EU/1/00/166/002 – 5000 U
EU/1/00/166/003 – 10,000 U

Date of first authorisation: 22 January 2001
Date of latest renewal: 29 November 2010

Drugs

Drug
Countries
Austria, Cyprus, Estonia, Spain, Finland, France, Ireland, Lithuania, Poland