Call for independent scientific experts to join EMA’s Pharmacovigilance Risk Assessment Committee (PRAC)

Expressions of interest to be submitted to European Commission by 30 September 2017 ... Read more

EMA seeks views of public during its safety review of valproate

Registration opens for first public hearing ... Read more

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 July 2017

PRAC concluded two referrals and issued provisional measures for treatment of multiple sclerosis; PRAC aware of contraindication for valproate in France ... Read more

EMA restricts use of multiple sclerosis medicine Zinbryta

Restrictions are provisional measures while review of liver safety is ongoing ... Read more

EMA and EUnetHTA step up interaction to align data requirements

A new joint platform for parallel consultation will provide advice to medicine developers and facilitate access to medicines for patients ... Read more

EMA and FDA encourage use of innovative approaches in the development of medicines for Gaucher disease

Approach aims to facilitate development of medicines for rare paediatric diseases in general ... Read more

First ever guidance for stem cell therapies in animals published

Document gives advice on sterile manufacturing processes for veterinary stem cell medicines ... Read more

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2017

Eight medicines recommended for approval, including two medicines for chronic hepatitis C virus (HCV) infection ... Read more

Two new medicines recommended for the treatment of chronic hepatitis C

Maviret and Vosevi evaluated under accelerated assessment ... Read more

EMA recommends that Symbioflor 2 can continue to be used for irritable bowel syndrome

Medicine should no longer be used for other disorders of the gut ... Read more

EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs

Medicines where suitable alternative data are available can remain on market ... Read more

SGLT2 inhibitors: information on potential risk of toe amputation to be included in prescribing information

Diabetes patients reminded of importance of preventative foot care. ... Read more

Dienogest/ethinylestradiol can be used for acne after certain other treatments have failed

Use should be limited to women who choose oral contraception ... Read more

Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B

Further studies needed to assess risk of liver cancer with these medicines ... Read more

Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function

Recommendations for patients with kidney impairment updated in product information ... Read more

EMA recommends measures to ensure safe use of Keppra oral solution

Medicine should only be used with dosing syringe included in the package ... Read more

CHMP confirms recommendations for use of Zydelig

Patients should be monitored for infection and given antibiotics during and after treatment ... Read more

PRAC concludes review of Zydelig and issues updated recommendations for use

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Zydelig ... Read more

CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections

Medicines to be withdrawn due to serious allergic reactions and limited evidence of benefit ... Read more

EMA recommends new safety measures for Zydelig

Measures include close monitoring and use of antibiotics to prevent pneumonia ... Read more

Besponsa:

inotuzumab ozogamicin

(0)

... Read more

Skilarence:

dimethyl fumarate

(0)

... Read more

Axumin:

fluciclovine (18F)

(0)

... Read more

Prevomax:

maropitant

(0)

... Read more

Ucedane:

carglumic acid

(0)

... Read more

Erelzi:

etanercept

(0)

... Read more

Kevzara:

sarilumab

(0)

... Read more

Fotivda:

tivozanib

... Read more

Vosevi: sofosbuvir / velpatasvir / voxilaprevi

... Read more

Nitisinone MendeliKABS: nitisinone

... Read more

Imraldi:

adalimumab

... Read more

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan:

efavirenz / emtricitabine / tenofovir disoproxil

... Read more

Mavenclad:

cladribine

... Read more

Kisqali:

ribociclib

... Read more

Maviret: glecaprevir / pibrentasvir

... Read more

Brineura:

cerliponase alfa

(0)

... Read more

Spinraza:

nusinersen

(0)

... Read more

Respiporc FLUpan H1N1:

inactivated influenza A virus/human

strain: A/Jena/VI5258/2009(H1N1)pdm09

(0)

... Read more

Elmiron:

pentosan polysulfate sodium

(0)

... Read more

Suvaxyn PRRS MLV:

porcine respiratory and reproductive syndrome virus, live

... Read more

Innovax-ND-IBD:

cell-associated live recombinant turkey herpesvirus expressing the fusion protein of ND virus and the VP2 protein of IBD virus

... Read more

Vepured:

recombinant verotoxin 2e

... Read more

Exzolt:

fluralaner

... Read more

Ingelvac PCV FLEX:

Porcine circovirus type 2 ORF2 protein

(0)

... Read more

Trumenba:

meningococcal group b vaccine (recombinant, adsorbed)

(0)

... Read more

Ivabradine Accord:

ivabradine

(0)

... Read more

Varuby:

rolapitant

(0)

... Read more

Zeleris:

florfenicol / meloxicam

(0)

... Read more

Pemetrexed Hospira UK Limited:

pemetrexed

(0)

... Read more

Reagila:

cariprazine

... Read more

Concept paper on an addendum on terms and concepts of pharmacogenomic features related to metabolism to the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (EMA/CHMP/37646/2009)

Concept paper on revision of the guideline on clinical development of vaccines

Concept paper on the need for the development of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)

Draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

Concept paper on a guideline on the evaluation of medicinal products indicated for treatment of influenza

Concept paper on the revision of the guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population

Draft guideline on Guideline on core summary of product characteristics (SmPC) and package leaflet for iopamidol 300

Draft guideline on Guideline on core summary of product characteristics (SmPC) and package leaflet for iopamidol 370

Guideline on core SmPC and Package Leaflet for sodium iodide (131I) therapy capsule

Draft revised guideline on the conduct of bioequivalence studies for veterinary medicinal products