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
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