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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-02-05

RTF Template

Finnish Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	FIMEA/2024/003928
2. Name of Authorisation Holder	:	Takeda Oy
3. Address(es) of Site(s)	:	Ilmalankuja 3, Helsinki, 00240, Finland

4. Legally registered address of Authorisation Holder	:	PL 1406, Helsinki, FI-00101, Finland
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	:	2024-07-18
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: Takeda Oy

(ORG-100004216 / LOC-100092011)

, Ilmalankuja 3, Helsinki, 00240, Finland

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

2.4. Export

2.5. Other activities(s): Export to other EEA countries and taking customer orders

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2.4 Export is limited to medicinal products that are not used in human or animals.
2.3 Supply and 2.5.2 Taking customer orders are limited only to medicinal product Alofisel

Reason for Withdrawing:

New WDA issued, Authorisation Number FIMEA/2025/000412-2.

Union Format for a Wholesale Distribution Authorisation	FIMEA/2024/003928
	Page 1

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