PAZOPANIB 200 MG AND 400 MG TABLETS

Hazard statements (CLP)

H351, H360, H372, H411

Code

Statements

H351

Suspected of causing cancer

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

Carcinogenicity Category 2 H351 - Suspected of causing cancer. Reproductive toxicity Category 1B H360 - May damage fertility or the unborn child. Specific target organ toxicity - repeated Category 1 H372 - Causes damage to organs exposure 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 Causes damage to organs through prolonged or repeated exposure. Suspected of causing cancer. May cause reproductive effects. 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

MICROCRYSTALLINE CELLULOSE, PAZOPANIB HYDROCHLORIDE

Signal word

Danger

Hazard statements

H351 Suspected of causing cancer. H360 May damage fertility or the unborn child. H372 Causes damage to organs through prolonged or repeated exposure. H411 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 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/hearing protection.

Response

P308 + P313 IF exposed or concerned: Get medical advice/attention. P391 Collect spillage.

Storage

P405 Store locked up.

Disposal

P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

Supplemental label elements

19.4 % of the mixture consists of component(s) of unknown acute oral toxicity. 99.3 % of the mixture consists of component(s) of unknown acute dermal toxicity. 30.7 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 25.8 % 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.