Abobotulinumtoxin A Powder for Injection

Ipsen SA

Revision date : 2019-07-01

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Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

General Information

Revision date

2019-07-01

Product name

Abobotulinumtoxin A Powder for Injection

Product name

Abobotulinumtoxin A Powder for Injection

Identification on the label/Trade name

Dysport (125 to 500 Units strength for patient); Azzalure ; Dyslor

Product Synonyms

Clostridium botulinum-derived Botulinum Toxin A Powder for Injection; CNT52120 Powder for Injection; Clostridium BTX-A-haemagglutinin complex; Clostridium botulinum type A toxin-haemagglutinin complex Neurotoxic polypeptide complexed with hemagglutinin Muscle relaxant, peripherally acting

Chemical name

Neurotoxic polypeptide complexed with hemagglutinin

1.2.1 Relevant identified uses

Formulated pharmaceutical product packaged in final form for patient

supplier name

Ipsen SA

Emergency telephone

+44 (0) 3700-492-795

Icons in SDS

M004

Company Information

company name

Ipsen SA

e-mail address of the competent person responsible for the Safety Data Sheet

contact.web@ipsen.com

Section 2

SECTION 2: Hazards identification

(29 CFR 1910.1200) Exempt from the requirements of CLP as product is regulated as a medicinal product. Information is provided to inform users of the hazards associated with the use of the product.

2.2 Label elements

- Exempt from labelling requirements under CLP and HCS 2012

2.3 Other hazards

- Although this is not classified under CLP/GHS/HCS it contains a potent active pharmaceutical ingredient- a very small amount of botulinum toxin A - which may be fatal if swallowed or inhaled and which may cause neurological damage. - To the best of our knowledge, the ecological properties of this material have not been fully evaluated.

2.1 Classification of the substance or mixture

- Classification (REGULATION (EC) No 1272/2008) [CLP/GHS]: Not Classified Datasheet Number: IPS041 - v2.0.0 1 SECTION 2: Hazards identification (....) - Classification (29 CFR 1910.1200) [HCS 2012]: Not Classified - Additional information: For full text of Hazard- and EU Hazard-statements: see section 16

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