ERIVEDGE(R) Capsules (150 mg)

Hoffmann-La Roche Inc

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

Note: Ingredients listed on restricted chemical lists

EC/CAS

9004-34-6

Name of the chemical

cellulose

Concentration

25%

EC/CAS

9003-39-8

Name of the chemical

polyvinylpyrrolidone

Concentration

3%

EC/CAS

14807-96-6

Name of the chemical

Talc

Concentration

1%

General Information

Product name

ERIVEDGE(R) Capsules (150 mg)

Product Synonyms

- Hedgehog signaling pathway antagonist RO5450815

Icons in SDS

GHS08

Company Information

company name

Hoffmann-La Roche 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)

H360D, H360F, H373

Hazard statements

Code

Statements

H360D

May damage the unborn child

Section 2

SECTION 2: Hazards identification

GHS Classification Emergency Overview Form capsules Color grey pink Hazard Overview - May cause birth defects based on animal data. - may cause reproductive system effects based on animal data

Potential health effects

Exposure: Inhalation, Ingestion, Skin contact, Eye contact - Target Organs: gastrointestinal system, Skeletal system - Acute Effects: This material has not been tested as a whole; therefore, the information described below is based on one or more of its ingredients., May cause gastrointestinal effects., Signs and symptoms may include nausea, vomiting, diarrhea, constipation, cramps, and loss of appetite., May cause musculoskeletal effects., Signs and symptoms may include muscle weakness or pain and skeletal abnormalities., May cause loss of hair., May cause general body weakness, fatigue and nausea.

Potential chronic health

No adverse effects known - Carcinogenicity not listed by NTP IARC or

Health hazards

3.7 D Reproductive toxicity (Category 1B) H360D May damage the unborn child. 3.7 F Reproductive toxicity (Category 1B) H360F May damage fertility. 3.9 Specific target organ toxicity - Repeated exposure (Category 2) H373 May cause damage to organs.

Signal word

Danger Label:

Precautionary statements

P201 Obtain special instructions before use. - P260 Do not breathe dust - P308 + P313 IF exposed or concerned: Get medical advice/attention. - P273 Avoid release to the environment. - P501 Dispose of contents/container to waste disposal as hazardous waste Additional Health Information - Reproductive Toxicity: May cause birth defects based on animal data. May affect fertility (including sperm production, ovulation, motility and impotence) based on animal data. - Since this material may affect reproductive capabilities and the developing fetus, females and males planning to have a child, pregnant women and nursing mothers should exercise caution regarding potential exposure. *2 referring to: Povidone K29/32

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