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Two new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended two medicines for approval at its February 2020 meeting.

The Committee recommended granting a marketing authorisation for Fetcroja (cefiderocol) for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.

cefiderocol

The generic medicine Tigecycline Accord (tigecycline) received a positive opinion for the treatment of complicated skin and soft tissue (i.e. tissues just below the skin) infections and complicated intra-abdominal infections.

tigecycline

Three recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Alunbrig, Ofev and Otezla.

The CHMP also recommended the addition of a new pharmaceutical form for Entyvio: a 108 mg solution for injection to be given subcutaneously.

Negative opinion on extension of therapeutic indication

The CHMP adopted a negative opinion for an extension of indication for Emgality (galcanezumab) to add prevention of attacks in adults who suffer from episodic cluster headache.

29/02/2020

https://www.ema.europa.eu/en/

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