Bosulif (Bosutinib) Film Coated Tablets

Pfizer Inc

Revision date : 2025-06-16

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

Note: Ingredients listed on restricted chemical lists

EC/CAS

236-675-5/13463-67-7

Name of the chemical

Reaction mass of titanium dioxide and silver chloride

Concentration

*

EC/CAS

232-674-9/9004-34-6

Name of the chemical

cellulose

Concentration

limit (SCL

EC/CAS

106392-12-5

Name of the chemical

poly(ethylene propylene) glycol

Concentration

*

EC/CAS

9003-39-8

Name of the chemical

polyvinylpyrrolidone

Concentration

*

EC/CAS

209-150-3/25322-68-3

Name of the chemical

polyethyleneglycol

Concentration

*

EC/CAS

238-877-9/14807-96-6

Name of the chemical

Talc

Concentration

*

EC/CAS

257-098-5

Name of the chemical

Iron Oxide Yellow

Concentration

*

EC/CAS

215-168-2

Name of the chemical

Iron Oxide Red

Concentration

*

General Information

Version

9

Revision date

2025-06-16

Product name

Bosulif (Bosutinib) Film Coated Tablets

Product name

Bosulif (Bosutinib) Film Coated Tablets

Identification on the label/Trade name

BOSULIF

Chemical name

Not determined

1.2.1 Relevant identified uses

Pharmaceutical product Antineoplastic

Emergency telephone

1-800-424-9300, +1-703-527-3887

Icons in SDS

GHS07 GHS08 GHS09 M004 M009 M010 M011 M017

Company Information

company name

Pfizer Inc

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

pfizer-MSDS@pfizer.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H302, H317, H360FD, H400, H410

Hazard statements

Code

Statements

H302

Harmful if swallowed

Section 2

SECTION 2: Hazards identification

OSHA Classification of the substance or mixture

2.3 Other hazards

Not applicable (HNOC) An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8).

Signal word

Danger

Hazard statements

H302 - Harmful if swallowed H317 - May cause an allergic skin reaction H400 - Very toxic to aquatic life H410 - Very toxic to aquatic life with long lasting effects H360FD - May damage fertility. May damage the unborn child

Precautionary statements

P201 - Obtain special instructions before use P261 - Avoid breathing dust/fume/gas/mist/vapors/spray P264 - Wash hands thoroughly after handling P270 - Do not eat, drink or smoke when using this product P272 - Contaminated work clothing should not be allowed out of the workplace P273 - Avoid release to the environment P280 - Wear protective gloves/protective clothing/eye protection/face protection P308 + P313 - IF exposed or concerned: Get medical advice/attention P333 + P313 - If skin irritation or rash occurs: Get medical advice/attention P321 - Specific treatment (see supplemental first aid instructions on this label) P363 - Wash contaminated clothing before reuse P301 + P312 - IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell P330 - Rinse mouth P391 - Collect spillage P405 - Store locked up P501 - Dispose of contents/container in accordance with local, regional, national, and international regulations as applicable P302 + P352 - IF ON SKIN: Wash with plenty of soap and water

PBT Substances

& vPvB The product does not contain any substance(s) classified as PBT or vPvB. Endocrine Disruptor Information This product does not contain any known or suspected endocrine disruptors. Note This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.

2.1 Classification of the substance or mixture

GHS - Classification: Regulated according to Regulation (EC) 1272/2008 and/or other applicable regulations. Acute toxicity - Oral Category 4 - (H302) Skin sensitization Category 1 - (H317) Reproductive toxicity Category 1B - (H360FD) Hazardous to the aquatic environment - acute Category 1 - (H400) Hazardous to the aquatic environment - chronic Category 1 - (H410) OSHA Classification Hazards not otherwise classified (HNOC) Not applicable Hazards classified under paragraph (d)(1)(ii) of 1910.1200 Not applicable

SDS Library

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