Ofev

nintedanib

Opinion

On 27 February 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Ofev. The marketing authorisation holder for this medicinal product is Boehringer Ingelheim International GmbH.

The CHMP adopted a new indication as follows:

“Ofev is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease.”

For information, the full indications for Ofev will be as follows:

“Ofev is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF).

“Ofev is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Key facts

Name
Ofev
Agency product number
EMEA/H/C/003821
International non-proprietary name (INN) or common name
  • nintedanib
Active substance
  • nintedanib
Therapeutic area
Idiopathic Pulmonary Fibrosis
Accelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
27/02/2020
Company name
Boehringer Ingelheim International GmbH
Status
Positive
Application type
Post-authorisation

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