VALCYTE(R) F.C. Tablets (450 mg)

Genentech, Inc

Revision date : 2020-02-28

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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

9003-39-8

Name of the chemical

polyvinylpyrrolidone

Concentration

N/A

EC/CAS

9004-34-6

Name of the chemical

cellulose

Concentration

N/A

EC/CAS

57-11-4

Name of the chemical

stearic acid

Concentration

N/A

EC/CAS

13463-67-7

Name of the chemical

Reaction mass of titanium dioxide and silver chloride

Concentration

N/A

General Information

Revision date

2020-02-28

Product name

VALCYTE(R) F.C. Tablets (450 mg)

Product Synonyms

syno- Valganciclovir Film Coated Tablets 450 mg nym(s) of the substance

1.2.1 Relevant identified uses

Formulated pharmaceutical active substance

supplier name

Genentech, Inc

Icons in SDS

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)

H340, H350, H360FD, H372

Hazard statements

Code

Statements

H340

May cause genetic defects

Section 2

SECTION 2: Hazards identification

OSHA Hazards GHS classification in accordance with the OSHA Hazard Communication Standard (29 CFR 1910.1200) Germ cell mutagenicity Category 1B Carcinogenicity Category 1A Reproductive toxicity Category 1B Specific target organ toxicity Category 1 - repeated exposure

Signal word

Danger

Hazard statements

H340 May cause genetic defects. H350 May cause cancer. H360FD May damage fertility. May damage the unborn child. H372 Causes damage to organs through prolonged or repeated exposure.

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/ vapors/ spray. P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.

Response

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 dis- posal plant.

2.3 Other hazards

None known.

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