English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Sonata (zaleplon) – Conditions or restrictions regarding supply and use - N05CF03

Updated on site: 10-Oct-2017

Medication nameSonata
ATC CodeN05CF03
Substancezaleplon
ManufacturerMeda AB

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

MEDA Manufacturing GmbH

Neurather Ring 1

51063 Cologne

Germany

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The marketing authorisation holder shall submit periodic safety update reports f r this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the E ropean medicines web-portal.

authorised

 

 

 

longer

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE

USE OF THE MEDICINAL PRODUCT

 

 

Not applicable.

 

 

 

 

product

no

 

Medicinal

 

 

 

 

 

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed