SAPHRIS

Allergan plc

Revision date : 2019-07-16

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GHS08
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

9000-70-8

Name of the chemical

gelatin

Concentration

N/A

EC/CAS

69-65-8

Name of the chemical

D-mannitol C6H14O6

Concentration

N/A

EC/CAS

57-55-6

Name of the chemical

1,2-propanediol

Concentration

N/A

EC/CAS

200-711-8

Name of the chemical

D-mannitol C6H14O6

Concentration

N/A

General Information

Revision date

2019-07-16

Product name

SAPHRIS

Product Synonyms

Asenapine Sublingual Tablets

1.2.1 Relevant identified uses

Schizophrenia in adults. Bipolar I disorder o Acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age o Adjunctive

Manufacturer Name

Allergan plc

Emergency telephone

Call CHEMTREC Day or Night

Icons in SDS

Company Information

company name

Allergan plc

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

SDS@Allergan.com

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H351, H361

Hazard statements

Code

Statements

H351

Suspected of causing cancer

Section 2

2.1 Classification of the substance or mixture

OSHA Regulatory Status This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Carcinogenicity Category 2 Reproductive toxicity Category 2

2.2 Label elements

Emergency Overview Warning

Hazard statements

H351 - Suspected of causing cancer H361 - Suspected of damaging fertility or the unborn child Appearance Tablet Physical state Solid Odor No information available Chemical Name Symptoms Asenapine The most common adverse events associated with asenapine were restlessness, decreased sensitivity of the mouth, sleepiness, dizziness, and weight increase. Chemical Name

Medical Conditions Generally Aggravated by Exposure

Asenapine Contradictions include severe hepatic impairment and hypersensitivity to SAPHRIS (asenapine), or to any components in the formulation.

Precautionary statements

P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood P281 - Use personal protective equipment as required P308 + P313 - IF exposed or concerned: Get medical advice/attention P405 - Store locked up P501 - Dispose of contents/ container to an approved waste disposal plant

Further information

Unknown Acute Toxicity 81% of the mixture consists of ingredient(s) of unknown toxicity Over the counter drugs in their solid form are considered exempt under the criteria of the Federal OSHA Hazard Communication Standard 20 CFR 1910.1200. However, in an industrial setting where a component's occupational exposure limit may be surpassed, than can be considered hazardous

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