ZEJULA TABLETS

GlaxoSmithKline Korea

Revision date : 2021-01-12

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GHS07 GHS08 GHS09
Health risk rating 5
Safety risk rating 1
Environmental risk rating 5

Note: Ingredients listed on restricted chemical lists

EC/CAS

13463-67-7

Name of the chemical

Reaction mass of titanium dioxide and silver chloride

Concentration

N/A

EC/CAS

9003-39-8

Name of the chemical

polyvinylpyrrolidone

Concentration

N/A

General Information

Revision date

2021-01-12

Product name

ZEJULA TABLETS

Product Synonyms

NIRAPARIB TOSYLATE MONOHYDRATE, FORMULATED PRODUCT

supplier name

GlaxoSmithKline Korea

Emergency telephone

VERISK 3E GLOBAL INCIDENT RESPONSE

Icons in SDS

Company Information

company name

GlaxoSmithKline Korea

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

msds@gsk.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H302, H340, H361, H373, H410

Hazard statements

Code

Statements

H302

Harmful if swallowed

Section 2

SECTION 2: Hazards identification

A. Hazard category/Classification

Physical hazards

Not classified.

Health hazards

Acute toxicity, oral Category 4 Germ cell mutagenicity Category 1B Reproductive toxicity Category 2 Specific target organ toxicity following Category 2 repeated exposure

Environmental hazards

Hazardous to the aquatic environment, Category 1

Long term hazards

B. Warning label items including precautionary statement

Signal word

Danger

Hazard statements

H302 Harmful if swallowed. H340 May cause genetic defects. H361 Suspected of damaging fertility or the unborn child. H373 May cause damage to organs through prolonged or repeated exposure. H410 Very toxic to aquatic life with long lasting effects.

Prevention

P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P260 Do not breathe dust/fume/gas/mist/vapours/spray. P264 Wash hands thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P273 Avoid release to the environment. P280 Wear protective gloves/protective clothing/eye protection/face protection.

Response

P301 + P312 IF SWALLOWED: Call a POISON CENTRE or doctor/physician if you feel unwell. P330 Rinse mouth. P308 + P313 IF exposed or concerned: Get medical advice/attention. P320 Specific treatment is urgent (see Information on this label). P391 Collect spillage.

Storage

P405 Store locked up.

Disposal

P501 Dispose of contents/container in accordance with local/regional/national/international regulations. C. Other hazards not included Caution - Potent pharmaceutical agent. See section 11 for additional information on health in the hazard category criteria hazards. (e.g. dust explosion hazard)

Additional information

36.265 % of the mixture consists of component(s) of unknown acute oral toxicity. 99.565 % of the mixture consists of component(s) of unknown acute dermal toxicity. 49.285 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment.

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