JASCAYD (nerandomilast) tablets

Boehringer Ingelheim Pharmaceuticals Inc

Revision date : 2025-12-25

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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

9004-34-6

Name of the chemical

cellulose

Concentration

>=10-<20

EC/CAS

13463-67-7

Name of the chemical

Reaction mass of titanium dioxide and silver chloride

Concentration

>=0.1-<1

General Information

Version

3.1

Revision date

2025-12-25

Product name

JASCAYD (nerandomilast) tablets

Product Synonyms

BI 1015550 film-coated tablets 6 mg, BI 1015550 film-coated tablets 9 mg, BI 1015550 film-coated tablets 12 mg, BI 1015550 film-coated tablets 18 mg with active ingredient: Nerandomilast

1.2.1 Relevant identified uses

Pharmaceutical Development compound

1.2.2. Uses advised against

Safety Data Sheet only for the professional user

supplier name

Boehringer Ingelheim Pharmaceuticals Inc

Emergency telephone

+1 703-527-3887, +1 703-741-5970

Icons in SDS

GHS08 M004 M009 M010 M011 M017 M059

Company Information

company name

Boehringer Ingelheim Pharmaceuticals Inc

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)

H361, H372

Hazard statements

Code

Statements

H361

Suspected of damaging fertility or the unborn child

Section 2

SECTION 2: Hazards identification

2.3 Other hazards

This drug is not subject to the labelling requirements under the Globally Harmonized System (GHS) The pharmacological effect of the medicament has to be considered (see package leaflet). Hazards associated with a change in physical form: This product does not contain titanium dioxide in its respirable form and would not be considered carcinogenic; however, upon crushing, grinding or other processing that could result in the gener- ation of respirable particulates, the Category 2 carcinogenic classification would apply.

Signal word

Danger

Hazard statements

H361 Suspected of damaging fertility or the unborn child. H372 Causes damage to organs (Heart, Bone) through pro- longed or repeated exposure if swallowed.

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. P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.

Response

P308 + P313 IF exposed or concerned: Get medical advice/ attention.

Storage

P405 Store locked up.

Disposal

P501 Dispose of contents/ container to an approved waste dis- posal plant.

Ingredient(s) with unknown acute toxicity

2.92 %

2.1 Classification of the substance or mixture

1910.1200) Hazards for the product as supplied Reproductive toxicity : Category 2 Specific target organ toxicity : Category 1 (Heart, Bone) - repeated exposure (Oral) Other hazards This drug is not subject to the labelling requirements under the Globally Harmonized System (GHS) The pharmacological effect of the medicament has to be considered (see package leaflet). Hazards associated with a change in physical form: This product does not contain titanium dioxide in its respirable form and would not be considered carcinogenic; however, upon crushing, grinding or other processing that could result in the gener- ation of respirable particulates, the Category 2 carcinogenic classification would apply.

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