Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2016

Eight medicines recommended for approval, including four orphan medicines ... Read more

New medicine for rare, chronic liver disease

Ocaliva recommended for conditional approval ... 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

Sales of veterinary antibiotics continue to decline in most European countries

Quality of data improves as 29 countries collect and provide information ... Read more

First comprehensive overview of global initiatives on medicine regulation published

Mapping aims to improve international collaboration ... Read more

EMA Management Board: highlights of October 2016 meeting

Board elects Grzegorz Cessak as vice-chair, adopts Agency’s mid-year report and signs off reflection paper on European medicines web portal ... Read more

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 October 2016

CVMP opinions on veterinary medicinal products ... Read more

New medicine to protect honey bees against Varroa mites

VarroMed recommended for marketing authorisation ... Read more

IT systems unavailable from 28 October to 1 November 2016

EMA website and online applications will be temporarily unavailable ... 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Medicines to be withdrawn due to serious allergic reactions and limited evidence of benefit ...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

EMA confirms recommendations to minimise risk of brain infection PML with Tysabri

More frequent MRI scans should be considered for patients at higher risk ... Read more

EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes

Healthcare professionals should be aware of possible atypical cases ... Read more

EMA concludes defective device in ROCKET study does not impact Xarelto’s safety

Study is the main trial supporting use of Xarelto in atrial fibrillation ... Read more

EMA recommends avoidance of certain hepatitis C medicines and amiodarone together

Concomitant use may increase risk of slow heart rate and related problems ... Read more

Cystadrops:

mercaptamine

... Read more

Emtricitabine / Tenofovir disoproxil Krka:

emtricitabine / tenofovir disoproxil

... Read more

SomaKit TOC:

edotreotide

... Read more

Venclyxto:

venetoclax

... Read more

Ocaliva:

obeticholic acid

... Read more

Emtricitabine / Tenofovir disoproxil Mylan:

emtricitabine / tenofovir disoproxil

... Read more

Tenofovir disoproxil Mylan:

tenofovir disoproxil

... Read more

Rekovelle:

follitropin delta

... Read more

Cabometyx :

cabozantinib

(0)

... Read more

VarroMed:

oxalic acid dihydrate / formic acid

... Read more

Cepedex:

dexmedetomidine hydrochloride

... Read more

Halagon:

halofuginone

... Read more

Truberzi:

eluxadoline

(0)

... Read more

Sialanar:

glycopyrronium

(0)

... Read more

Nordimet:

methotrexate

(0)

... Read more

Glyxambi:

empagliflozin / linagliptin

... Read more

Granpidam:

sildenafil

... Read more

Ivabradine JensonR:

ivabradine

... Read more

Lartruvo:

olaratumab

... Read more

Emtricitabine/Tenofovir disoproxil Zentiva:

emtricitabine / tenofovir disoproxil

... Read more

Ivabradine Zentiva:

ivabradine

... Read more

Chenodeoxycholic acid sigma-tau:

chenodeoxycholic acid

... Read more

Parsabiv:

etelcalcetide

... Read more

Ibrance:

palbociclib

... Read more

Sedadex:

dexmedetomidine hydrochloride

(0)

... Read more

Zalmoxis:

allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)

(0)

... Read more

Airexar Spiromax:

salmeterol xinafoate / fluticasone propionate

(0)

... Read more

Aerivio Spiromax:

salmeterol / fluticasone propionate

(0)

... Read more

Cinqaero:

reslizumab

(0)

... Read more

Bortezomib Sun:

bortezomib

(0)

... Read more

Concept paper on good manufacturing practice and marketing authorisation holders

Concept paper for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza, blue tongue and foot and mouth disease

Concept paper for the revision of the note for guidance on the use of adjuvanted veterinary vaccines

Concept paper on the revision of the 'Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographical and mixed applications) and in applications for simplified registration'

Draft guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinal products

Draft questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies

Concept paper on the need for revision of the guideline on the clinical development of medicinal products for the treatment of cystic fibrosis (CHMP/EWP/9147/2008) - Revision 1

Draft exenatide powder and solvent for prolonged-release suspension for injection, 2 mg, and powder and solvent for prolonged-release suspension for injection in pre-filled pen, 2 mg product-specific bioequivalence guidance

Draft vemurafenib film-coated tablets 240 mg product-specific bioequivalence guidance

Draft paliperidone palmitate depot suspension for injection 25, 50, 75, 100 and 150 mg product-specific bioequivalence guidance