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Active Substance: insulin human
Common Name: insulin human
ATC Code: A10AF01
Marketing Authorisation Holder: Pfizer Limited
Active Substance: insulin human
Status: Withdrawn
Authorisation Date: 2006-01-24
Therapeutic Area: Diabetes Mellitus
Pharmacotherapeutic Group: Drugs used in diabetes

Therapeutic Indication

EXUBERA is indicated for the treatment of adult patients with type 2 diabetes mellitus not
adequately controlled with oral antidiabetic agents and requiring insulin therapy.
EXUBERA is also indicated for the treatment of adult patients with type 1 diabetes mellitus, in
addition to long or intermediate acting subcutaneous insulin, for whom the potential benefits of
adding inhaled insulin outweigh the potential safety concerns (see section 4.4).

The marketing authorisation for Exubera has been withdrawn at the request of the marketing authorisation holder.

Source: European Medicines Agency

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