ROZLYTREK Capsules 200 mg

Genentech, Inc

Revision date : 2025-06-14

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GHS08 GHS05
Health risk rating 5
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

63-42-3

Name of the chemical

Lactose C12H22O11

Concentration

N/A

EC/CAS

87-69-4

Name of the chemical

L-(+)-tartaric acid

Concentration

N/A

EC/CAS

9003-39-8

Name of the chemical

polyvinylpyrrolidone

Concentration

N/A

EC/CAS

9004-65-3

Name of the chemical

methylhydroxypropylcellulose

Concentration

N/A

EC/CAS

9004-34-6

Name of the chemical

cellulose

Concentration

N/A

EC/CAS

13463-67-7

Name of the chemical

Reaction mass of titanium dioxide and silver chloride

Concentration

N/A

EC/CAS

7631-86-9

Name of the chemical

Silver adsorbed on silicon dioxide

Concentration

N/A

General Information

Revision date

2025-06-14

Product name

ROZLYTREK Capsules 200 mg

Product Synonyms

Entrectinib with other ingredients

1.2.1 Relevant identified uses

Formulated pharmaceutical active substance

supplier name

Genentech, Inc

Emergency telephone

001-(650) 225-1000, (800)-424-9300

Icons in SDS

GHS05 GHS08 M004 M009 M010 M011 M013 M017

Company Information

company name

Genentech, Inc

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

info.sds@roche.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H318, H350

Hazard statements

Code

Statements

H318

Causes serious eye damage

Section 2

SECTION 2: Hazards identification

Signal word

Danger

Hazard statements

H318 Causes serious eye damage. H350 May cause cancer.

Prevention

P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.

Response

P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor. P308 + P313 IF exposed or concerned: Get medical advice/ attention.

Storage

P405 Store locked up.

Disposal

P501 Dispose of contents/ container to an approved waste disposal plant.

Other hazards

None known

2.1 Classification of the substance or mixture

1910.1200) Serious eye damage : Category 1 Carcinogenicity

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