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- PMLiVE

Otsuka’s Pletal has use restricted in Europe

EMA recommends drug only be used in limited group of patients with blood supply disorder

- PMLiVE

Black triangle monitoring warning to be used across EU

Use of symbol is part of EMA plans to strengthen pharmacovigilance

- PMLiVE

Vanda withdraws EU application for schizophrenia drug

CHMP had previously refused to back the approval of Fanaptum

- PMLiVE

EMA’s Pharmacovigilance Risk Assessment Committee gains new members

Filip Babylon to represent HCP organisations and Albert van der Zeijden to represent patient organisations

- PMLiVE

AbbVie sues EMA to block Humira data release

Pharma company seeks injunction following FOI requests for raw data

- PMLiVE

Novartis provides multimedia support to Rare Diseases Day

Collaborates with Eurordis on multimedia education campaign

- PMLiVE

EMA application fees set for slower rise in 2013

European regulator expects rate to increase by 2.6 per cent

- PMLiVE

Shining a light on orphan medicines

Orphan diseases represent one of the most exciting and emotive areas in modern medicine and need a communications strategy that covers a spectrum of issues

- PMLiVE

CHMP upholds rejection of Vivus’ obesity drug

Still no recommendation for Qsiva in Europe

- PMLiVE

Gentium expects EMA rejection for defibrotide

Negative feedback for drug’s use in liver condition associated with stem cell transplantation

- PMLiVE

FDA says approval of generic Doxil will ease cancer drug shortage

Allows Sun Pharma to manufacture its own version of the medicine

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