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- PMLiVE

etesevimab

- 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

EMA application fees set for slower rise in 2013

European regulator expects rate to increase by 2.6 per cent

- 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

Bayer’s Diane 35 faces ban in France

Follows investigation into blood clot-related deaths

- PMLiVE

EMA starts contraceptive safety probe

Follows French investigation into Bayer’s Diane 35

Novartis building

Novartis withdraws application for Ruvise approval in EU

Had submitted imatinib mesylate for use in hypertension

- PMLiVE

EMA publishes marketing application guidance for pharma

Aims to clarify what to include in summaries of product characteristics

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