Note: Ingredients listed on restricted chemical lists
EC/CAS
9003-39-8
Name of the chemical
polyvinylpyrrolidone
Concentration
N/A
General Information
Revision date
2021-04-12
Product name
ELTROMBOPAG 50 MG TABLETS
Product Synonyms
ELTROMBOPAG OLAMINE, FORMULATED PRODUCT
1.2.1 Relevant identified uses
Bulk Formulated Product
Icons in SDS
Company Information
company name
GlaxoSmithKline UK
e-mail address of the competent person responsible for the Safety Data Sheet
msds@gsk.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H302, H373, H411
Hazard statements
Code
Statements
H302
Harmful if swallowed
Section 2
2.1 Classification of the substance or mixture
The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies.
EU Classification
Regulation (EC) No 1272/2008 as amended
Health hazards
Acute toxicity, oral Category 4 H302 - Harmful if swallowed. Specific target organ toxicity - repeated Category 2 H373 - May cause damage to exposure organs through prolonged or repeated exposure.
Environmental hazards
Hazardous to the aquatic environment, Category 2 H411 - Toxic to aquatic life with long-term aquatic hazard long lasting effects. Hazard summary Harmful if swallowed. May cause damage to organs through prolonged or repeated exposure. Prolonged exposure may cause chronic effects. Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards. Dangerous for the environment if discharged into watercourses.
2.2 Label elements
Label according to Regulation (EC) No. 1272/2008 as amended
Contains
ELTROMBOPAG OLAMINE, MICROCRYSTALLINE CELLULOSE
Signal word
Warning
Hazard statements
H302 Harmful if swallowed. H373 May cause damage to organs through prolonged or repeated exposure. H411 Toxic to aquatic life with long lasting effects.
Prevention
P260 Do not breathe dust/fume/gas/mist/vapours/spray. P264 Wash thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P273 Avoid release to the environment.
Response
P330 Rinse mouth. P314 Get medical advice/attention if you feel unwell. P391 Collect spillage.
Storage
Not available.
Disposal
P501 Dispose of contents/container in accordance with local/regional/national/international regulations.
Supplemental label elements
51.9 % of the mixture consists of component(s) of unknown acute oral toxicity. 78.85 % of the mixture consists of component(s) of unknown acute dermal toxicity. 78.85 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 59.6 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment.
2.3 Other hazards
Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.
