Committee for Medicinal Products for Veterinary Use re-elects Dr Anja Holm as chair

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) re-elected Dr Anja Holm as its chair for a second three-year term at its June 2013 meeting. ... Read more

European Medicines Agency revises MUMS / limited-market policy

The European Medicines Agency has published a public statement revising the operation of the minor-use-minor-species (MUMS) / limited-market policy (MUMS policy) for veterinary medicines. ... Read more

European Medicines Agency’s Management Board endorses revised EMA code of conduct

At its meeting held on 13 June 2013, the European Medicines Agency’s (EMA's) Management Board adopted the revised EMA code of conduct, which aims to ensure that the Agency maintains the highest professional standards of integrity, transparency and independence. ... Read more

Registration opens for workshop on EMA-HTA parallel scientific advice in drug development

The European Medicines Agency (EMA) is inviting expressions of interest in attending its workshop on parallel scientific advice in drug development with health-technology-assessment (HTA) bodies on 26 November 2013. ... Read more

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 June 2013

The Committee elected Dr Anja Holm from Denmark as its chair for a second three-year mandate. ... Read more

PRAC recommends the same cardiovascular precautions for diclofenac as for selective COX-2 inhibitors

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the effects of the painkiller diclofenac on the heart and circulation when given systemically (by means such as capsules, tablets or injections) are similar to those of selective COX-2 inhibitors, another group of painkillers. ... Read more

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2013

The Pharmacovigilance Risk Assessment Committee (PRAC) made recommendations on four safety referrals at its June 2013 meeting. ... Read more

PRAC recommends restricting the use of flupirtine-containing medicines

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of flupirtine-containing medicines and recommended restrictions in their use. ... Read more

PRAC recommends restricting the use of codeine when used for pain relief in children

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended a series of measures to address safety concerns with codeine-containing medicines when used for the management of pain in children. ... Read more

PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl starch

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded following a review of the available evidence that the benefits of infusion solutions containing hydroxyethyl starch (HES) no longer outweigh their risks and therefore recommended that the marketing authorisations for these medicines be suspended. ... Read more

European Medicines Agency recommends new advice on safer use of fibrin sealant spray applications

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European Medicines Agency recommends new advice to surgeons on safer use of fibrin sealants Evicel and Quixil

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European Medicines Agency starts infringement procedure to investigate Roche’s alleged non-compliance with pharmacovigilance obligations

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European Medicines Agency finalises review of recent published data on cardiovascular safety of NSAIDs

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European Medicines Agency gives recommendations to deal with sterility assurance concerns for DepoCyte

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European Medicines Agency recommends limiting long-term use of calcitonin medicines

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European Medicines Agency advises doctors treating patients with nosocomial pneumonia with Doribax

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European Medicines Agency recommends restricting use of trimetazidine-containing medicines

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European Medicines Agency recommends restricting use of tolperisone medicines

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European Medicines Agency confirms positive benefit-risk balance of MabThera

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Porcilis ColiClos:

Clostridium perfringens type C / Escherichia coli F4ab / E. coli F4ac / E. coli F5 / E. coli F6 / E. coli LT

(0)

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Stribild:

elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil

(0)

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Voriconazole Accord:

voriconazole

(0)

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HyQvia:

human normal immunoglobulin

(0)

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Voncento:

human coagulation factor VIII / Von Willebrand factor

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Somatropin Biopartners:

somatropin

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Lojuxta:

lomitapide

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Imvanex:

modified Vaccinia Ankara Virus

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Lonquex:

lipegfilgrasim

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Pomalidomide Celgene:

pomalidomide

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Atosiban Sun:

atosiban

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Maruxa:

memantine

(0)

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AFTOVAXPUR DOE:

1-3 inactivated, purified FMD virus(es) out of a set of 7 (multistrain)

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ProZinc:

insulin human

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Ecoporc Shiga:

genetically modified recombinant Shiga-toxin-2e antigen

(0)

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Meloxidolor:

meloxicam

(0)

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Imatinib Actavis:

imatinib

(0)

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Nemdatine:

memantine

(0)

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Memantine Mylan:

memantine

(0)

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Memantine LEK:

memantine

(0)

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Capecitabine SUN:

capecitabine

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Spedra:

avanafil

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Imatinib Accord:

imatinib

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Xtandi:

enzalutamide

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Erivedge:

vismodegib

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Maci:

autologous cultured chondrocytes

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Nuedexta:

dextromethorphan hydrobromide/quinidine sulfate

... Read more

Jetrea:

ocriplasmin

(0)

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Equilis West Nile:

inactivated chimeric Flavivirus strain YF-WN

... Read more

Bosulif:

bosutinib

(0)

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Draft Community herbal monograph on Curcuma xanthorrhiza roxb., rhizoma

Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure

Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products

Guideline on good pharmacovigilance practices: Module XVI – Risk-minimisation measures: selection of tools and effectiveness indicators

Revised provisional priority list for studies into off-patent paediatric medicinal products

Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease

Draft guideline on the clinical development of medicinal products intended for the treatment of pain

Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances

Draft inventory of paediatric medicines - Infectious diseases