Annovera

Mayne Pharma

Revision date : 2023-02-08

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GHS08
Health risk rating 5
Safety risk rating 1
Environmental risk rating 3

Note: Ingredients listed on restricted chemical lists

EC/CAS

13463-67-7

Name of the chemical

Reaction mass of titanium dioxide and silver chloride

Concentration

<5

General Information

Version

3.1

Revision date

2023-02-08

Product name

Annovera

Product Synonyms

Segesterone acetate and ethinyl estradiol vaginal system

Chemical name

Not Applicable

1.2.1 Relevant identified uses

Bulk formulated pharmaceutical mixture/Formulated pharmaceutical product/mixture packaged in final form for patient use Use according to manufacturer"s directions

Emergency telephone

1 800 424 9300, +1 703 527 3887, +61 1800 951 288, +61 3 9573 3188

Icons in SDS

GHS08 M004 M008 M009 M010

Company Information

company name

Mayne Pharma

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H341, H350, H360F, H362, H412

Hazard statements

Code

Statements

H341

Suspected of causing genetic defects

Section 2

SECTION 2: Hazards identification

No 1272/2008 Classification of the substance or mixture

2.2 Label elements

Page 1 continued...

Signal word

Danger

Hazard statements

H341 Suspected of causing genetic defects. H350 May cause cancer. H360F May damage fertility. H362 May cause harm to breast-fed children. H412 Harmful to aquatic life with long lasting effects. *LIMITED EVIDENCE

Prevention

P201 Obtain special instructions before use. P260 Do not breathe dust/fume. P263 Avoid contact during pregnancy and while nursing. P280 Wear protective gloves and protective clothing. P270 Do not eat, drink or smoke when using this product. P273 Avoid release to the environment. P264 Wash all exposed external body areas thoroughly after handling.

Response

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

Storage

P405 Store locked up.

Disposal

P501 Dispose of contents/container to authorised hazardous or special waste collection point in accordance with any local regulation.

2.1 Classification of the substance or mixture

[1] Lactation, Hazardous to the Aquatic Environment Long-Term Hazard Category 3 *LIMITED EVIDENCE Legend: 1. Classified by Chemwatch; 2. Classification drawn from HCIS; 3. Classification drawn from Regulation (EU) No 1272/2008 - Annex VI

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