European Medicines Agency

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World Hypertension Day

The European Medicines Agency supports World Hypertension Day, which is taking place on Friday 17 May 2013.

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17/05/2013
European Medicines Agency reiterates PRAC recommendation for Diane 35 and generics
Following the conclusion of the Pharmacovigilance Risk Assessment Committee (PRAC) that the benefits of Diane 35 and its generics outweigh the risks in a specific patient group, the French National Agency for the Safety of Medicine and Health Products (ANSM) unexpectedly announced today the decision to suspend the marketing authorisations of these medicines in France. ... Read more
17/05/2013
International Clinical Trials Day: 20 May 2013
The European Medicines Agency supports International Clinical Trials Day, which is taking place on Monday 20 May 2013. ... Read more
17/05/2013
Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 14-16 May 2013
The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for ProZinc (insulin human) from Boehringer Ingelheim Vetmedica GmbH, for the treatment of diabetes mellitus in cats to achieve reduction of hyperglycaemia and improvement of associated clinical signs. ... Read more
17/05/2013
European Medicines Agency recommends first vaccine for foot-and-mouth disease for authorisation at EU level
The European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has recommended the marketing authorisation for Aftovaxpur DOE for use in response to outbreaks of foot-and-mouth disease (FMD). ... Read more
17/05/2013
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2013
European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefits of Diane 35 (cyproterone acetate 2 mg, ethinylestradiol 35 micrograms) and its generics outweigh the risks in a specific patient group, provided that several measures are taken to minimise the risk of thromboembolism, including new contraindications and warnings. ... Read more
17/05/2013
Benefits of Diane 35 and generics outweigh risks in specific patient group
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefits of Diane 35 (cyproterone acetate 2 mg, ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided that several measures are taken to minimise the risk of thromboembolism (formation of blood clots in the veins and arteries). ... Read more
16/05/2013
European Medicines Agency closed 20 May 2013
The European Medicines Agency will be closed from 6.30pm on Friday 17 May until 7.30am on Tuesday 21 May 2013. ... Read more
16/05/2013
World Hypertension Day: 17 May 2013
The European Medicines Agency supports World Hypertension Day, which is taking place on Friday 17 May 2013. ... Read more
08/05/2013
European Medicines Agency simplifies processing of fee reductions for orphan medicines
The European Medicines Agency has cancelled the procedure by which sponsors of medicines with an orphan designation need to inform the Agency of their intention to submit an application in order to be eligible for a fee reduction. ... Read more
08/05/2013
Comments invited on draft revised guideline on biosimilars
The European Medicines Agency (EMA) has revised its overarching guideline on similar biological medicines and published a draft for public consultation. ... Read more
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16/05/2013
veterinary
AFTOVAXPUR DOE:
1-3 inactivated, purified FMD virus(es) out of a set of 7 (multistrain)
... Read more
16/05/2013
veterinary
ProZinc:
insulin human
... Read more
16/05/2013
veterinary
Ecoporc Shiga:
genetically modified recombinant Shiga-toxin-2e antigen
(0)
... Read more
13/05/2013
veterinary
Meloxidolor:
meloxicam
(0)
... Read more
06/05/2013
human
Imatinib Actavis:
imatinib
(0)
... Read more
30/04/2013
human
Nemdatine:
memantine
(0)
... Read more
29/04/2013
human
Memantine Mylan:
memantine
(0)
... Read more
29/04/2013
human
Memantine LEK:
memantine
(0)
... Read more
21/03/2013
human
Capecitabine SUN:
capecitabine
... Read more
25/04/2013
human
Maci:
autologous cultured chondrocytes
... Read more
25/04/2013
human
Spedra:
avanafil
... Read more
25/04/2013
human
Nuedexta:
dextromethorphan hydrobromide/quinidine sulfate
... Read more
25/04/2013
human
Imatinib Accord:
imatinib
... Read more
25/04/2013
human
Xtandi:
enzalutamide
... Read more
25/04/2013
human
Erivedge:
vismodegib
... Read more
18/04/2013
human
Jetrea:
ocriplasmin
(0)
... Read more
11/04/2013
veterinary
Equilis West Nile:
inactivated chimeric Flavivirus strain YF-WN
... Read more
09/04/2013
human
Bosulif:
bosutinib
(0)
... Read more
08/04/2013
human
Tolucombi:
telmisartan / hydrochlorothiazide
(0)
... Read more
02/04/2013
human
Perjeta:
pertuzumab
(0)
... Read more
26/03/2013
veterinary
Pexion:
imepitoin
(0)
... Read more
26/03/2013
human
Actelsar HCT:
telmisartan / hydrochlorothiazide
(0)
... Read more
21/03/2013
human
HyQvia:
human normal immunoglobulin
... Read more
21/03/2013
human
Memantine ratiopharm:
memantine hydrochloride
... Read more
3/21/2013
human
Voriconazole Accord:
voriconazole
... Read more
21/03/2013
human
Stayveer:
bosentan monohydrate
... Read more
21/03/2013
human
Tecfidera:
dimethyl fumarate
... Read more
21/03/2013
human
Stribild:
elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil
... Read more
21/03/2013
human
Aubagio:
teriflunomide
... Read more
21/03/2013
human
Iclusig:
ponatinib
... Read more
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World Hypertension Day

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