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19/10/2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2018

The CHMP recommended six medicines for approval, three extensions of indications and elected its new vice-chair at its October 2018 meeting.

19/10/2018

New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin

The European Medicines Agency has recommended granting a marketing authorisation for Takhzyro (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and...

19/10/2018

First treatment for rare inherited muscle contraction disorders

The European Medicines Agency has recommended granting a marketing authorisation for Namuscla (mexiletine hydrochloride) for the treatment of adult patients with non-dystrophic myotonia, a group of inherited muscle disorders where muscles are slow...

19/10/2018

First vaccine for prevention of dengue

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Dengvaxia (dengue tetravalent vaccine (live, attenuated)), for the prevention of dengue caused by dengue...

17/10/2018

Shaping regulatory science to 2025

EMA is hosting a workshop on Wednesday, 24 October to gather insight from stakeholders on the key areas in human medicines to be covered in its ‘Regulatory Science Strategy to 2025’, a proposed new high-level plan for advancing its engagement with...

15/10/2018

Sales of antibiotics for use in food-producing animals drop across the EU

A report published today by the European Medicines Agency (EMA) shows that the overall sales of veterinary antimicrobials across Europe have decreased by more than 20% between 2011 and 2016. This continues the downward trend seen over the last few...

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CHMP highlights 15-18 October 2018

CHMP highlights 15-18 October 2018

Shaping regulatory science to 2025

Shaping regulatory science to 2025

Sales of antibiotics for use in animals drop across the EU

Sales of antibiotics for use in animals drop across the EU

Update on Brexit preparations

Update on Brexit preparations

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2018

New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin

First treatment for rare inherited muscle contraction disorders

First vaccine for prevention of dengue

Shaping regulatory science to 2025

Sales of antibiotics for use in food-producing animals drop across the EU

Information for

Key content

Product emergency hotline

UK’s withdrawal from the EU

PRIME: Priority medicines

Pharmacovigilance (safety monitoring)

Data on medicines

Clinical data publication

Careers

Services & databases

Account Management portal

eSubmission

EudraVigilance (human)

EU Veterinary Medicinal Product Database

Suspected adverse drug reactions database

Clinical data

SPOR data management services

How does EMA work?

What we do

Our role in authorisation of medicines

Who we are

Our scientific experts

How we work

What we publish

CHMP highlights 15-18 October 2018

CHMP highlights 15-18 October 2018

Shaping regulatory science to 2025

Shaping regulatory science to 2025

Sales of antibiotics for use in animals drop across the EU

Sales of antibiotics for use in animals drop across the EU

Update on Brexit preparations

Update on Brexit preparations

Latest news

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2018

New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin

First treatment for rare inherited muscle contraction disorders

First vaccine for prevention of dengue

Shaping regulatory science to 2025

Sales of antibiotics for use in food-producing animals drop across the EU

Information for

Key content

Product emergency hotline

UK’s withdrawal from the EU

PRIME: Priority medicines

Pharmacovigilance (safety monitoring)

Data on medicines

Clinical data publication

Careers

Services & databases

Account Management portal

eSubmission

EudraVigilance (human)

EU Veterinary Medicinal Product Database

Suspected adverse drug reactions database

Clinical data

SPOR data management services

How does EMA work?

What we do

Our role in authorisation of medicines

Who we are

Our scientific experts

How we work

What we publish