GSK3368715B TABLETS

GlaxoSmithKline UK

Revision date : 2020-01-17

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GHS07 GHS08
Health risk rating 4
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

N/A

EC/CAS

13463-67-7

Name of the chemical

Reaction mass of titanium dioxide and silver chloride

Concentration

N/A

EC/CAS

209-150-3

Name of the chemical

Aluminium, zinc, magnesium and calcium stearates

Concentration

N/A

EC/CAS

236-675-5

Name of the chemical

Titandioxid; [in Pulverform mit mindestens 1 % Partikel mit aerodynamischem Durchmesser ≤ 10 μm] (2020/217)

Concentration

N/A

General Information

Revision date

2020-01-17

Product name

GSK3368715B TABLETS

Product Synonyms

ETHER CYCLOHEXYL DERIVATIVE * GSK3368715 TABLETS, FORMULATED PRODUCT

1.2.1 Relevant identified uses

Investigational Medicinal Product

Emergency telephone

VERISK 3E GLOBAL INCIDENT RESPONSE

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Company Information

company name

GlaxoSmithKline UK

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

msds@gsk.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H302, H361, H372

Hazard statements

Code

Statements

H302

Harmful if swallowed

Section 2

EU Classification

Regulation (EC) No 1272/2008 as amended

Health hazards

Acute toxicity, oral Category 4 H302 - Harmful if swallowed. Reproductive toxicity Category 2 H361 - Suspected of damaging fertility or the unborn child. Specific target organ toxicity - repeated Category 1 H372 - Causes damage to organs exposure through prolonged or repeated exposure. Hazard summary Assume that this product is capable of sustaining combustion. Caution - Potent pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.

2.2 Label elements

Label according to Regulation (EC) No. 1272/2008 as amended

Contains

CROSCARMELLOSE SODIUM, GSK3368715B, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, Titanium dioxide

Signal word

Danger

Hazard statements

H302 Harmful if swallowed. H361 Suspected of damaging fertility or 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/vapours/spray. P264 Wash 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

P301 + P312 IF SWALLOWED: Call a POISON CENTRE/doctor/ if you feel unwell. P330 Rinse mouth. P308 + P313 IF exposed or concerned: Get medical advice/attention.

Storage

P405 Store locked up.

Disposal

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

Supplemental label elements

37,7 % of the mixture consists of component(s) of unknown acute oral toxicity. 73,25 % of the mixture consists of component(s) of unknown acute dermal toxicity. 73,25 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 73,25 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment.

2.3 Other hazards

Assume that this product is capable of sustaining combustion. Caution - Potent pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.

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