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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-01-09

RTF Template

Swedish Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	6.2.7-2023-088050
2. Name of Authorisation Holder	:	Kyowa Kirin AB (ORG-100001238 / LOC-100058238)
3. Address(es) of Site(s)	:	Torshamnsgatan 39, Spanga, Kista, 164 40, Sweden

4. Legally registered address of Authorisation Holder	:	Torshamnsgatan 39, Spanga, Kista, 164 40
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	:	2023-12-14
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: Kyowa Kirin AB

(ORG-100001238 / LOC-100058238)

, Torshamnsgatan 39, Spanga, Kista, 164 40, Sweden

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

3.1.1. Narcotic or psychotropic products

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Reason for Withdrawing:

Withdrawn 2025-01-09 at company's own request, dnr 5.9.4-2024-109673.

Union Format for a Wholesale Distribution Authorisation	6.2.7-2023-088050
	Page 1

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