Prempro Tablets

Pfizer Inc

Revision date : 2025-07-26

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GHS08 GHS09
Health risk rating 5
Safety risk rating 1
Environmental risk rating 5

Note: Ingredients listed on restricted chemical lists

EC/CAS

200-334-9/57-50-1

Name of the chemical

Sucrose, pure C12H22O11

Concentration

N/A

EC/CAS

232-674-9/9004-67-5

Name of the chemical

methylcellulose

Concentration

N/A

EC/CAS

209-150-3/9004-34-6

Name of the chemical

cellulose

Concentration

N/A

EC/CAS

9003-39-8

Name of the chemical

polyvinylpyrrolidone

Concentration

N/A

EC/CAS

247-038-6/25322-68-3

Name of the chemical

polyethyleneglycol

Concentration

N/A

General Information

Version

3

Revision date

2025-07-26

Product name

Prempro Tablets

Product name

Prempro Tablets

Identification on the label/Trade name

PREMPRO, PREMIA, PREMELLE

Product Synonyms

Conjugated Estrogens and Medroxyprogesterone Acetate Tablets

Chemical name

Steroid

1.2.1 Relevant identified uses

Pharmaceutical product used for hormone replacement therapy

Emergency telephone

1-800-424-9300

Icons in SDS

GHS08 GHS09 M004 M009 M010 M011 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)

H350, H360DF, H360FD, H380, H400, H410, H430

Hazard statements

Code

Statements

H350

May cause 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

H350 - May cause cancer H360FD - May damage fertility. May damage the unborn child EUH380 - May cause endocrine disruption in humans H410 - Very toxic 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 and protective clothing 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

PBT Substances

& vPvB The product does not contain any substance(s) classified as PBT or vPvB. Endocrine Disruptor Information Contains a known or suspected endocrine disruptor. Chemical name Endocrine disrupting properties in accordance with the criteria set out in Commission Delegated Regulation (EU) 2017/2100(3) or Commission Regulation (EU) 2018/605(4) Medroxyprogesterone acetate Substance has endocrine disrupting properties Conjugated estrogens Substance has endocrine disrupting properties Note: This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.

2.1 Classification of the substance or mixture

GHS - Classification: Regulated according to Regulation (EC) 1272/2008 and/or other applicable regulations. Carcinogenicity Category 1A - (H350) Reproductive toxicity Category 1A - (H360DF) Endocrine disruption for human health Category 1 - (H380) Hazardous to the aquatic environment - acute Category 1 - (H400) Hazardous to the aquatic environment - chronic Category 1 - (H410) Endocrine disruption for the environment Category 1 - (H430) OSHA Classification Hazards not otherwise classified (HNOC) Not applicable Hazards classified under paragraph (d)(1)(ii) of 1910.1200 Not applicable

SDS Library

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