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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-07-22

RTF Template

Danish Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	104513
2. Name of Authorisation Holder	:	Grindeks Kalceks Danmark ApS (ORG-100051967 / LOC-100091394)
3. Address(es) of Site(s)	:	Klosterstraede 9, Copenhagen K, 1157, Denmark

4. Legally registered address of Authorisation Holder	:	Klosterstraede 9, Copenhagen K, 1157
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-04-25
10. Annexes attached	:	Annex 1 Scope of wholesale distribution authorisation Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number Annex 3 (Optional) Name(s) of responsible person(s) Annex 4 (Optional) Date of Inspection on which authorisation was granted Annex 5 (Optional) Additional provisions based on national requirements

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: Grindeks Kalceks Danmark ApS

(ORG-100051967 / LOC-100091394)

, Klosterstraede 9, Copenhagen K, 1157, Denmark

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Reason for Withdrawing:

Withdrawn due to no futher activites

Union Format for a Wholesale Distribution Authorisation	104513
	Page 1

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