List of medicinal products registered by competent authorities (18.10.2019)

21.10.2019 5558 views

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LIST OF MEDICINAL PRODUCTS FOR WHICH THE REVIEW OF REGISTRATION MATERIALS SUBMITTED FOR STATE REGISTRATION HAS BEEN COMPLETED, WHICH ARE REGISTERED BY THE COMPETENT AUTHORITIES OF THE UNITED STATES OF AMERICA, SWITZERLAND, JAPAN, AUSTRALIA, CANADA, AND MEDICINAL PRODUCTS REGISTERED UNDER THE CENTRALIZED PROCEDURE BY THE COMPETENT AUTHORITY OF THE EUROPEAN UNION

*No.*	*Name of the medicinal product*	*Presentation (pharmaceutical form, packaging)*	*Applicant*	*Country*	*Manufacturer*	*Country*	*Registration procedure*	*Conditions of dispensing*	*Advertising*	*Registration certificate number*
1.	VERDAI	powder for solution for injection, 25 mg; 25 mg in a dark glass vial; 5 vials in a cardboard box	Diagnostic Green GmbH	Germany	manufacturer responsible for batch release: Diagnostik Grün GmbH, Germany; manufacture of bulk product and primary packaging: PATHEON ITALIA S.P.A., Italy; secondary packaging: Sixarp, LLC, USA	Germany/ Italy/ USA	registration for 5 years	by prescription	Not applicable	UA/17747/01/01

No.

Name of the medicinal product

Presentation (pharmaceutical form, packaging)

Applicant

Country

Manufacturer

Country

Registration procedure

Conditions of dispensing

Advertising

Registration certificate number

VERDAI

powder for solution for injection, 25 mg; 25 mg in a dark glass vial; 5 vials in a cardboard box

Diagnostic Green GmbH

Germany

manufacturer responsible for batch release:

Diagnostik Grün GmbH, Germany;

manufacture of bulk product and primary packaging:

PATHEON ITALIA S.P.A., Italy;

secondary packaging:

Sixarp, LLC, USA

Germany/

Italy/

USA

registration for 5 years

by prescription

Not applicable

UA/17747/01/01