Wakix (pitolisant) 4.45 mg and 17.8 mg Tablets

Harmony Biosciences, LLC

Revision date : 2019-10-03

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GHS07
Health risk rating 4
Safety risk rating 1
Environmental risk rating 5

Note: Ingredients listed on restricted chemical lists

EC/CAS

25322-68-3

Name of the chemical

polyethyleneglycol

Concentration

N/A

General Information

Revision date

2019-10-03

Product name

Wakix (pitolisant) 4.45 mg and 17.8 mg Tablets

Product Synonyms

• Ciproxidine; Pitolisant Hydrochloride; Tiprolisant

1.2.1 Relevant identified uses

Pharmaceutical for human use in treatment of excessive daytime sleepiness in adult patients with narcolepsy

1.2.2. Uses advised against

Any use not directed by prescribing physician

Manufacturer Name

Harmony Biosciences, LLC

Icons in SDS

GHS07

Company Information

company name

Harmony Biosciences, LLC

GHS Information

Signal word

WARNING

Section 2

SECTION 2: Hazards identification

OSHA HCS 2012 United States (US) According to: OSHA 29 CFR 1910.1200 HCS

2.1 Classification of the substance or mixture

OSHA HCS 2012 • Skin Irritation 2 Eye Irritation 2 Effects on or via Lactation

2.2 Label elements

OSHA HCS 2012 WARNING

Hazard statements

Causes skin irritation Causes serious eye irritation

Prevention

Obtain special instructions before use Do not breathe dust. Avoid direct contact during pregnancy/while nursing. Wash thoroughly after handling. Do not eat, drink or smoke when handling this product. Wear protective gloves/protective clothing/eye protection/face protection.

Response

If on skin Wash with plenty of water Take off contaminated clothing and wash before reuse. Specific treatment, see supplemental first aid information. If skin irritation occurs: Get medical advice/attention. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. IF exposed or concerned: Get medical advice/attention.

2.3 Other hazards

OSHA HCS 2012 • Under United States Regulations (29 CFR 1910.1200 - Hazard Communication Standard), this product is considered hazardous.

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