Active ingredients: Botulinum toxin type B
NeuroBloc 5000 U/ml solution for injection.
Solution for injection.
Clear and colourless to light yellow solution.
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.
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.
Human serum albumin
Hydrochloric acid (for pH adjustment)
Water for injections
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.
Sloan Pharma S.à.r.l., 33, Rue du Puits Romain, 8070 Bertrange, Luxembourg
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