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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-06-06

RTF Template

Norwegian Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products

1. Authorisation Number	:	22/07957-2
2. Name of Authorisation Holder	:	Nextmune AS (ORG-100037025 / LOC-100075568)
3. Address(es) of Site(s)	:	Grensevegen 811, Magnor, 2240, Norway

4. Legally registered address of Authorisation Holder	:	Grensevegen 811, Magnor, 2240
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2022-04-21
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: Nextmune AS

(ORG-100037025 / LOC-100075568)

, Grensevegen 811, Magnor, 2240, Norway

Veterinary medicinal products

1. MEDICINAL PRODUCTS

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): The authorsation is limited to Heska Immucept solution for injection and Heska Immucept Sublingual Allergy Treatment exempted from marketing authorisation by the Norwegian Medicines Agency for use on animals.

Reason for Withdrawing:

The authorisation has been terminated by the company from 1 May 2025.

Union Format for a Wholesale Distribution Authorisation	22/07957-2
	Page 1

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