Medroxyprogesterone Acetate Suspension - Uniject

Pfizer Inc

Revision date : 2025-08-01

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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

215-185-5/1310-73-2

Name of the chemical

sodium hydroxide

Concentration

0.5%< >=5% <5% 0.5%<

EC/CAS

231-595-7/7647-01-0

Name of the chemical

Hydrochloric acid

Concentration

<25% 017-002- >=25% <25% >=10%

EC/CAS

231-791-2/7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

10%<=C<25%

EC/CAS

231-598-3/25322-68-3

Name of the chemical

polyethyleneglycol

Concentration

*

EC/CAS

500-019-9/9003-39-8

Name of the chemical

polyvinylpyrrolidone

Concentration

*

EC/CAS

500-019-9/9005-65-6

Name of the chemical

polyethyleneglycol sorbitan monooleate

Concentration

0.05-0.1

EC/CAS

202-785-7/99-76-3

Name of the chemical

4-hydroxybenzoic acid, methyl ester

Concentration

N/A

EC/CAS

94-13-3

Name of the chemical

Propylparaben; propyl 4-hydroxybenzoate

Concentration

N/A

EC/CAS

202-307-7

Name of the chemical

Propylparaben; propyl 4-hydroxybenzoate

Concentration

0.01-0.1

General Information

Version

9

Revision date

2025-08-01

Product name

Medroxyprogesterone Acetate Suspension - Uniject

Product name

Medroxyprogesterone Acetate Suspension - Uniject

Identification on the label/Trade name

DEPO-PROVERA; SAYANA

Product Synonyms

Medroxyprogesterone Suspension for Injection, Subcutaneous; DEPO-SUBQ PROVERA; Medroxyprogesterone Suspension for Injection, Subcutaneous; DEPO-SUBQ PROVERA; depo-subQ provera 104

Chemical name

Mixture

1.2.1 Relevant identified uses

Pharmaceutical product used as contraceptive agent

Icons in SDS

GHS08 M004 M009 M010 M017

Company Information

company name

Pfizer Inc

e-mail address of the competent person responsible for the Safety Data Sheet

pfizer-MSDS@pfizer.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H351, H360FD, H402, H412

Hazard statements

Code

Statements

H351

Suspected of causing cancer

Section 2

SECTION 2: Hazards identification

OSHA Classification of the substance or mixture

2.3 Other hazards

Not applicable (HNOC) An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8).

Signal word

Danger

Hazard statements

H351 - Suspected of causing cancer H360FD - May damage fertility. May damage the unborn child EUH380 - May cause endocrine disruption in humans H412 - Harmful to aquatic life with long lasting effects EUH430 - May cause endocrine disruption in the environment

Precautionary statements

P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood P263 - Avoid contact during pregnancy/while nursing P273 - Avoid release to the environment P280 - Wear protective gloves, protective clothing, eye protection and face protection P308 + P313 - IF exposed or concerned: Get medical advice/attention P391 - Collect spillage P405 - Store locked up P501 - Dispose of contents/container in accordance with local, regional, national, and international regulations as applicable Unknown acute toxicity 16 % of the mixture consists of ingredient(s) of unknown acute dermal toxicity. 16 % of the mixture consists of ingredient(s) of unknown acute inhalation toxicity (dust/mist).

PBT Substances

& vPvB The product does not contain any substance(s) classified as PBT or vPvB. Endocrine Disruptor Information Chemical name Contains a known or suspected endocrine disruptor.

2.1 Classification of the substance or mixture

GHS - Classification. Regulated according to Regulation (EC) 1272/2008 and/or other applicable regulations. Carcinogenicity Category 2 - (H351) Reproductive toxicity Category 1A - (H360FD) Endocrine disruption for human health Category 1 - (EUH380) Hazardous to the aquatic environment - acute Category 3 - (H402) Hazardous to the aquatic environment - chronic Category 3 - (H412) Endocrine disruption for the environment Category 1 - (EUH430) OSHA Classification Hazards not otherwise classified (HNOC) Not applicable Hazards classified under paragraph (d)(1)(ii) of 1910.1200 Not applicable

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