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엠파글리플로진-메트포르민 복합제(서방정) 4품목 허가사항 변경 (변경일자: 2025-12-01)

2025.09.08

첨부파일: 「반출」엠파글리플로진-메트포르민 복합제서방정 통일조정 허가사항 변경대비표.hwpx

ㅇ제품명:
엠파프로메트서방정5/1000밀리그램 (엠파글리플로진,메트포르민)
엠파프로메트서방정12.5/1000밀리그램 (엠파글리플로진,메트포르민)
엠파프로메트서방정10/1000밀리그램 (엠파글리플로진,메트포르민)
엠파프로메트서방정25/1000밀리그램 (엠파글리플로진,메트포르민)

ㅇ변경항목: 효능효과, 사용상의 주의사항
ㅇ변경사유: 식품의약품안전처 변경명령
ㅇ변경일자: 2025.12.01
ㅇ첨부파일: 변경대비표

다음글: 비리얼정(테노포비르디소프록실오로트산염) 허가사항 변경 (변경일자: 2025-11-18)
2025.09.08

이전글: 다파프로메트서방정5/1000밀리그램, 다파프로메트서방정5/500밀리그램, 다파프로메트서방정10/1000밀리그램, 다파프로메트서방정10/500밀리그램 허가사항 변경 (변경일자: 2025-11-07)
2025.08.11

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DMB-3115 Data Protection Notice

Last Edited on [2023-05-02]

This Privacy Notice describes the personal data that Dong-A ST Co., Ltd. (hereafter “Dong-A”, “us”, “we”, “our”") collects through our website located at http://en.donga-st.com/Main.da that are specific to our product coded DMB-3115 in relation to all clinical trials and regulatory approvals in Europe and how we use and keep safe that information.

Dong-A as the Controller of the personal data has committed to comply with the General Data Protection Regulation N°EU 2016/679 (hereinafter, the "GDPR") and all EU applicable laws and regulations regarding data protection collectively referred as "Data Protection Laws". In compliance with the GDPR, we appointed Data Protection Officer listed below who performs his or her the tasks as required by the GDPR.

With this Privacy Notice, Dong-A aims at ensuring that you understand what personal information is collected about you, how your personal information is used and how it is kept safe.

GENERAL WARNING AND USE OF SOCIAL MEDIA

Access to the Website implies the User’s full and unreserved acceptance of this Privacy Notice (hereinafter the “Notice”), as well as its general terms of use. The User acknowledges having read the information below.

The Notice is valid for all pages hosted on the Website. It is not valid for the pages hosted by third parties to which we may refer and whose privacy notices may differ. Dong-A cannot therefore be held responsible for any data processed on these websites or by third parties. This Notice also applies to any other website that Dong-A may operate.

1. Why, how and for how long do we collect your personal data?

We will only process your personal data in connection with specific purposes. We will keep them for no longer than necessary to fulfill the purposes for which we collected it, including any legal requirements.

Depending on each case, the processing will therefore be as follows:

Purposes	Types of personal data	Legal basis	Retention period
To answer to your queries	Name, email address, Please note that other Personal Data may be processed by Dong-A depending on your request and the information you provide us.	This processing is based on our legitimate interest in answering the requests or queries raised by you through the existing different contact channels We understand that the processing of these data is also beneficial to you to the extent that it enables us to assist you adequately and answer to the queries raised.	We will process your data for the time necessary to meet your request.
For statistical purposes	Aggregate statistical data	We consider that we have lawful interest to understand the way our page is consulted (e.g., how many times our page is consulted, from which country, etc.).	We may export statistical reports, but we guarantee that this is only in an anonymous form.

2. Data sharing

We do not sell or trade your personal data to third parties.

However, Dong-A has contracted with the following Services Providers to manage the Website that may have access to your personal data:

- DA Information for Hosting.

Sharing your personal data as explained above may involve a transfer of personal data to a country outside the European Economic Area (EEA), we are therefore committed to complying with the transfer rules under applicable Data Protection Laws and therefore ensure to:

• Transfer your data to countries where the data recipient is located that has been recognized as adequate by the European Commission; or

• Where a country has not received an adequacy decision from the European Commission, to implement appropriate safeguards, such as the EU Standard Contractual Clauses ("SCCs").

You can contact our DPO (see contact details below) if you want to have more details about the mechanism supporting data transfer.

3. How do we protect your information?

We process your personal data in a confidential manner and provide a sufficient and adequate level of protection of your personal data.

Your personal data is housed behind secured networks and are only accessible by a limited number of persons who have special access rights to such systems and are required to keep the information confidential.

4. Your rights

According to the GDPR, you have the following rights:

- Access. You have the right to obtain confirmation as to whether or not personal data concerning you are being processed, and, where that is the case, information related to the processing of data and a copy of the data being processed.

- Rectification. You have the right to require rectification of inaccurate data about you.

- Right to be forgotten. To obtain the deletion of your personal data in the situations set forth by applicable data protection law.

- Restrict processing. You have the right to restrict processing of data under certain specified circumstances.

- Rectification. You have the right to require rectification of inaccurate data about you.

- Data portability. You have the right to request for the receipt or the transfer to another organization, in a machine-readable form, of your personal data.

- Object to processing. You have the right to object, on grounds relating to your particular situation, at any time to the processing of your data.

- Right to withdraw consent. When you have given your explicit consent for the processing of your data (e.g., Subscription to the Newsletter), you can withdraw it at any time without justification.

Please note that all these rights are not absolute and will be assessed on a case-by-case basis by our Data Protection Officer (DPO).

If you would like to exercise your rights, please let us know by contacting our DPO at dong-a.dpo@mydata-trust.info.

You have also the right to lodge a complaint if you consider that your personal data is not processed in accordance with the GDPR.

If you are an EEA resident: You have the right to lodge a complaint with the Data Protection Authority in the Member State of the European Union of your habitual residence, place of work or place of the alleged infringement.

Please find the contact information of all Authorities in section 6 "Contacts".

5. Changes to this Privacy Notice

This Notice is effective as of the date stated at the top of this page. We may change this Notice from time to time. Please refer back to this Notice on a regular basis.

6. Contacts

If you have any questions or comments about this Notice or our practices regarding your personal data, please contact us.

Dong-A ST Co. Ltd., acting as Controller

64, Cheonho-Daero, Dongdaemun-Gu

Seoul 02587, Republic of Korea

email: st_ciso@donga.co.kr

telephone: +82 2 920 8254

Data Protection Officer

MyData-TRUST SA

Boulevard Initialis, 7 bt 3 – 7000 Mons (BELGIUM)

For EU Data Protection Authorities

https://edpb.europa.eu/about-edpb/about-edpb/members_en