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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-03-16

RTF Template

Austrian Federal Office For Safety In Health Care

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	483904
2. Name of Authorisation Holder	:	Novartis Pharma GmbH (ORG-100000218 / LOC-100045276)
3. Address(es) of Site(s)	:	Schemmerlstrasse 72, Simmering, Vienna, 1110, Austria

4. Legally registered address of Authorisation Holder	:	Jakov-Lind-Strasse 5, Top 3.05, Leopoldstadt, Vienna, 1020
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	:	2020-10-07
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: Novartis Pharma GmbH

(ORG-100000218 / LOC-100075700)

, Schemmerlstrasse 72, Simmering, Vienna, 1110, Austria

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

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): Novartis Pharma GmbH - Außenlager SCHACHINGER pharmalogistik GmbH; Keine / none

Novartis Pharma GmbH - Außenlager SCHACHINGER pharmalogistik GmbH; Keine / none

Reason for Withdrawing:

The licence issued in accordance with § 63 para 1 or § 63a para 2 or 3 or § 65 para 1 shall become void if the operating licence holder relinquishes it (austrian medicinal products act).

Union Format for a Wholesale Distribution Authorisation	483904
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