Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 December 2015

CVMP opinions on veterinary medicinal products ... Read more

“EMA ready to address challenges ahead”

Support to innovative medicines, transparency and patient involvement will be among the priorities of new EMA Executive Director Guido Rasi ... Read more

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 November - 3 December 2015

During its December meeting, the PRAC discussed two ongoing referrals. ... Read more

Safer use of medicines by preventing medication errors

EMA makes new webpage and good practice guide available ... Read more

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 November 2015

Ten medicines, including a first-in-class orphan medicine for narcolepsy, recommended for authorisation in the EU ... Read more

HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS

Reports after HPV vaccination consistent with what would be expected in this age group ... Read more

Narcolepsy treatment recommended for approval

Wakix to target excessive daytime sleepiness and cataplexy ... Read more

New strategy to fight antimicrobial resistance

EMA veterinary committee sets objectives to limit risks arising from use of antimicrobials in animals ... Read more

European Antibiotic Awareness Day 2015

EMA reinforces commitment to help combat antimicrobial resistance ... Read more

Guido Rasi takes office as head of EMA

Executive Director appointed for five-year term ... 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

Codeine not to be used in children below 12 years for cough and cold

The CMDh has agreed by consensus new measures to minimise the risk of serious side effects, including breathing problems, with codeine-containing medicines when used for cough and cold in children. ... Read more

New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines

Use to be avoided in patients at greatest risk and doses to be kept low ... Read more

Ambroxol and bromhexine expectorants: safety information to be updated

Risk of allergy and skin reactions to be included in the product information ... Read more

GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies

Medicines considered critically important for patients to remain available ... Read more

European Medicines Agency recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)

The European Medicines Agency (EMA) has completed a review of Corlentor/Procoralan (ivabradine) and has made recommendations aimed at reducing the risk of heart problems, including heart attack and bradycardia (excessively low heart rate), in patients taking the medicine for angina. ... Read more

European Medicines Agency recommends further measures to minimise risk of blood vessel blockage with Iclusig

The European Medicines Agency (EMA) has concluded its review of the benefits and risks of Iclusig (ponatinib), a medicine used for the treatment of leukaemia (cancer of the white blood cells), and has recommended strengthened warnings in the product information aimed at minimising the risk of blood clots and blockages in the arteries. ... Read more

European Medicines Agency completes review of polymyxin-based medicines

Recommendations issued for safe use in patients with serious infections resistant to standard antibiotics ... Read more

EMA confirms positive benefit-risk for antidepressant Valdoxan/Thymanax (agomelatine)

Measures introduced to improve monitoring of liver function during treatment ... Read more

CMDh endorses restricted use of bromocriptine for stopping breast milk production

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed by majority recommendations on the use of bromocriptine-containing medicines by mouth to prevent or suppress breast milk production (lactation) after childbirth. ... Read more

Elocta:

efmoroctocog alfa

(0)

... Read more

Cotellic:

cobimetinib

(0)

... Read more

Edistride:

dapagliflozin

(0)

... Read more

Pemetrexed medac:

pemetrexed

(0)

... Read more

Kolbam :

cholic acid

(0)

... Read more

Blincyto:

blinatumomab

(0)

... Read more

Nucala:

mepolizumab

(0)

... Read more

Genvoya:

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

(0)

... Read more

Pemetrexed Hospira:

pemetrexed

(0)

... Read more

Kyprolis:

carfilzomib

(0)

... Read more

Orkambi:

lumacaftor / ivacaftor

(0)

... Read more

Entresto:

sacubitril / valsartan

(0)

... Read more

Praxbind:

idarucizumab

(0)

... Read more

Ionsys:

fentanyl

(0)

... Read more

Cinacalcet Mylan:

cinacalcet

(0)

... Read more

Aripiprazole Accord:

aripiprazole

(0)

... Read more

Numient:

levodopa / carbidopa

(0)

... Read more

Obizur:

susoctocog alfa

(0)

... Read more

Ebymect:

dapagliflozin / metformin

(0)

... Read more

Wakix:

pitolisant

... Read more

Pemetrexed Actavis:

pemetrexed

... Read more

Pemetrexed Accord:

pemetrexed

... Read more

Lopinavir/Ritonavir Mylan:

lopinavir/ritonavir

... Read more

Benepali:

etanercept

... Read more

Episalvan:

birch bark extract

... Read more

Briviact:

brivaracetam

... Read more

Oncaspar:

pegaspargase

... Read more

Spectrila:

asparaginase

... Read more

Zycortal:

desoxycortone pivalate

(0)

... Read more

Cresemba:

isavuconazole

(0)

... Read more

Draft European Union herbal monograph on Althaea officinalis L., radix

Draft public statement on Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum

Draft public statement on Salvia fruticosa Mill., folium

Concept paper for revision of the recommendation for the basic surveillance of EudraVigilance Veterinary data

Draft Committee for Medicinal Products for Veterinary Use strategy on antimicrobials 2016-2020

Draft guideline on clinical investigation of medicinal products for prevention of venous thromboembolism in non-surgical patients (formerly CPMP/EWP/6235/04 Rev.1)

Draft scientific guidance on post-authorisation efficacy studies

Draft reflection paper on a proposal to enhance early dialogue to facilitate accelerated assessment of priority medicines (PRIME)

Draft European Union herbal monograph on Pelargonium sidoides DC and / or Pelargonium reniforme Curt., radix

Draft European Union herbal monograph on Polygonum aviculare L., herba