Giotrif Tablets

Hazard statements (CLP)

H319, H361d, H362, H372, H411

Code

Statements

H319

Causes serious eye irritation

SECTION 2: Hazards identification

Regulation (EC) No. 1272/2008 Classification of the substance or mixture

Signal word

Danger

Hazard statements

H319 Causes serious eye irritation. H361d Suspected of damaging the unborn child. H362 May cause harm to breast-fed children. H372 Causes damage to organs (Skin, Gastro-intestinal system) through prolonged or repeated exposure. H411 Toxic to aquatic life with long lasting effects.

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. P263 Avoid contact during pregnancy and while nursing. P273 Avoid release to the environment. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.

Response

P391 Collect spillage.

Hazardous Ingredients

Afatinib dimaleate

Additional information

EUH212 Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.

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) Eye irritation, Category 2 H319: Causes serious eye irritation. Reproductive toxicity, Category 2 H361d: Suspected of damaging the unborn child. Effects on or via lactation H362: May cause harm to breast-fed children. Specific target organ toxicity - repeated H372: Causes damage to organs through pro- exposure, Category 1, Skin, Gastro- longed or repeated exposure. intestinal system Long-term (chronic) aquatic hazard, Cat- H411: Toxic to aquatic life with long lasting effects. egory 2