WHO Collaborating Centre for Drug Statistics Methodology
Norwegian Institute of Public Health
P.O.Box 4404 Nydalen
0403 Oslo
Norway
Visiting address:
Marcus Thranes gate 6,
0473 Oslo, Norway
Tel: + 47 21 07 81 60
Fax: +47 21 07 81 46
E-mail:

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Application form

Print version

ATC
DDD (Marketing authorization is needed)

Requested by

Name:
Company:
Address:
Country:
Email:

Active ingredients (preferably INN names):
INN request number:
Brand name:
Dosage form:
Strengths:
Manufacturer:
Main indication*:
Other indications*:		* References should be given and submitted (e.g. from SPC)
Approved dose recommendations*:
ATC code proposal:
DDD proposal:

Status concerning Marketing Authorization

Marketing Authorization (MA) has been approved in the following countries¹⁾²⁾:

Date of approval:

MA application has been submitted in the following countries²⁾:

Date of submission:

A MA application has not yet been submitted, but is planned , in the following countries:

1) If the indication(s) in any country differ from those given in the application form, please describe these differences in a separate enclosure.
2) Please indicate type of application (e.g. National, Centralised Procedure, etc)

Documentation and references (e.g SPC/Prescribing information), in English only, should be uploaded on the next page.

Last updated: 2009-10-28