General Information
Version
4.5
Revision date
2025-10-06
Product name
Ofev , Vargatef , Cyendiv Capsules
Product Synonyms
Ofev® Capsules 25 mg, 100 mg and 150 mg; Cyendiv® Cap- sules 25 mg, 100 mg and 150 mg; Vargatef® Capsules 25
1.2.1 Relevant identified uses
Pharmaceutical
1.2.2. Uses advised against
Safety Data Sheet only for the professional user on use
Emergency telephone
+498007790900, +1 703-527-3887, +49800 1817059
Icons in SDS
Company Information
company name
Boehringer Ing. Pharma GmbH & Co. KG
e-mail address of the competent person responsible for the Safety Data Sheet
EHS-Services@Boehringer-Ingelheim.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H360Df, H372
Hazard statements
Code
Statements
H360Df
May damage the unborn child; Suspected of damaging fertility
Section 2
SECTION 2: Hazards identification
Regulation (EC) No. 1272/2008 Classification of the substance or mixture
Signal word
Danger
Hazard statements
H360Df May damage the unborn child. Suspected of dam- aging fertility. H372 Causes damage to organs (Gastro-intestinal sys- tem, Liver) through prolonged or repeated expo- sure.
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. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.
Response
P308 + P313 IF exposed or concerned: Get medical advice/ attention.
Disposal
P501 Dispose of contents/ container to an approved waste disposal plant.
Hazardous Ingredients
Salt of ethanesulfonic acid and methyl (Z)-3-({4-[N-methyl-2-(4-methylpiperazin-1- yl)acetamido]anilino}(phenyl)methylidene)-2-oxoindoline-6-carboxylate (1:1)
2.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumula- tive and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.
ECOLOGICAL INFORMATION
The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regu- lation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
TOXICOLOGICAL INFORMATION
The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher. The pharmacological effect of the medicament has to be considered (see package leaflet). This drug is not subject to the labelling requirements under the Globally Harmonized System (GHS)
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) Reproductive toxicity, Category 1B H360Df: May damage the unborn child. Suspected of damaging fertility. Specific target organ toxicity - repeated H372: Causes damage to organs through pro- exposure, Category 1, Gastro-intestinal longed or repeated exposure. system, Liver
