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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-05-04

RTF Template

Landesamt Fuer Soziales Jugend Und Versorgung

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_RP_01_WDA_2025/3112-0158/20250520
2. Name of Authorisation Holder	:	BIOTHERAX biochemisch-pharmazeutische GmbH (ORG-100018141 / LOC-100026922)
3. Address(es) of Site(s)	:	Binger Strasse 173, Ingelheim Am Rhein, Rhineland-Palatinate, 55216, Germany

4. Legally registered address of Authorisation Holder	:	Binger Strasse 173, Ingelheim Am Rhein, Rhineland-Palatinate, 55216
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	:	2025-05-20
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: BIOTHERAX biochemisch-pharmazeutische GmbH

(ORG-100018141 / LOC-100026922)

, Binger Strasse 173, Ingelheim Am Rhein, Rhineland-Palatinate, 55216, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

Any restrictions or clarifying remarks (for all users): Contracted company for storage and distribution:
Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany.
The competent authority is aware of the current product list, dated February 07, 2025.

Beauftragtes Unternehmen für Lagerung und Vertrieb:
Firma Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, 55216 Ingelheim am Rhein, Deutschland.
Die aktuelle Produktliste (Stand:07.02.2025) ist der zuständigen Behörde bekannt.

Reason for Withdrawing:

The authorisation issued on May 20, 2025, was suspended effective April 1, 2026, until May 31, 2027. The authorisation will be withdrawn thereafter.

Zum 01.04.2026 wurde das Ruhen der Erlaubnis vom 20.05.2025 mit Frist bis zum 31.05.2027 angeordnet. Danach erfolgt der Widerruf der Erlaubnis.

Union Format for a Wholesale Distribution Authorisation	DE_RP_01_WDA_2025/3112-0158/20250520
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