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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-08-18

RTF Template

Danish Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	102875
2. Name of Authorisation Holder	:	Ascendis Pharma Bone Diseases A/S (ORG-100012658 / LOC-100018347)
3. Address(es) of Site(s)	:	Tuborg Boulevard 12, Hellerup, 2900, Denmark Tuborg Boulevard 5, Hellerup, 2900, Denmark

4. Legally registered address of Authorisation Holder	:	Tuborg Boulevard 12, Hellerup, 2900
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	:	2023-09-27
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: Ascendis Pharma Bone Diseases A/S

(ORG-100012658 / LOC-100018347)

, Tuborg Boulevard 12, Hellerup, 2900, Denmark

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Name and address of the site: Ascendis Pharma Bone Diseases A/S

(ORG-100012658 / LOC-100080180)

, Tuborg Boulevard 5, Hellerup, 2900, Denmark

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Reason for Withdrawing:

Withdrawn due to no further GDP activities

Union Format for a Wholesale Distribution Authorisation	102875
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