Note: Ingredients listed on restricted chemical lists
EC/CAS
9004-65-3
Name of the chemical
methylhydroxypropylcellulose
Concentration
25%
EC/CAS
209-151-9
Name of the chemical
Aluminium, zinc, magnesium and calcium stearates
Concentration
1.50%
General Information
Revision date
2015-07-12
Product name
Nevirapine ER
Product Synonyms
C15-H14-N4-O, Nevarapine, NVP, “NNRTI dipyridodiazepinone antiviral/ antiretroviral/ HIV-I treatment”, cyclopropyl-4-methyl
1.2.1 Relevant identified uses
For treatment of human immunodeficiency virus (HIV), reduce the risk of HIV transmission from HIV pregnant women to the fetus
Manufacturer Name
Alvogen, Inc
Emergency telephone
1-844-842-8672
Icons in SDS
Company Information
company name
Alvogen, Inc
GHS Information
Signal word
None
Section 2
SECTION 2: Hazards identification
1999/45/EC EMERGENCY OVERVIEW
Product definition
This product is a white tablet (solid) with no odor
Health hazards
Intact Nevirapine Tablets are not considered to be a health hazard with normal handling Flammability Hazards: This product is non-flammable. Reactivity Hazards: None known
Environmental hazards
The Environmental effects of this product have not been investigated. Release of this product is not expected to have significant adverse effects in the aquatic environment. US DOT SYMBOLS CANADA (WHMIS) SYMBOLS EUROPEAN and (GHS) Hazard Symbols None Non-Regulated Material Complies with WHMIS 2015
Signal word
None
Classification according to GHS
None known
Precautionary statements
None known P264: Wash skin after handling. 2.3 HEALTH HAZARDS OR RISKS FROM EXPOSURE: SYMPTOMS OF OVEREXPOSURE BY ROUTE OF EXPOSURE: The most significant routes of exposure for this product are by skin contact or eye contact. ACUTE: INHALATION: No health effects are expected due to physical properties of the product. CONTACT WITH SKIN: No health effects are expected due to physical properties of the product EYE CONTACT: No health effects are expected due to physical properties of the product INGESTION: Not expected to cause gastrointestinal irritation. CHRONIC: None known TARGET ORGANS Acute None known Chronic: None known
2.1 Classification of the substance or mixture
EUROPEAN UNION DIRECTIVES: This product does not meet the definition of a hazardous substance or preparation as defined by 29 CFR 1910. 1200 AND the European Union Council Directives 67/548/EEC, 1999/45/EC, 1272/2008/EC and subsequent Directives. EU HAZARD CLASSIFICATION OF INGREDIENTS PER DIRECTIVE 1272/2008/EC: CAS# 129618-40-2 is not listed in ESIS CAS# 64044-51-5 is not listed in ESIS CAS# 9004-65-3 is not listed in ESIS EC# 209-151-9 This substance is not classified in the Annex VI of Directive 67/548/EEC Substances not listed either individually or in group entries must be self classified. Component(s) Contributing to Classification(s) All Ingredients
