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December 2016

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07/12/2016Report: Applications for new human medicines under evaluation by the CHMP: December 2016
07/12/2016Human medicines European public assessment report (EPAR): Multaq,

dronedarone

Revision: 9, Authorised
07/12/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Anti proprotein convertase subtilisin kexin type 9 humanized monoclonal antibody (PF-04950615)

Therapeutic area: Cardiovascular diseases/Endocrinology, -gynacology-fertility-metabolism (updated)
07/12/2016Referral: Article 31 referrals, Gadolinium-containing contrast agents,

gadobenic acid / gadobutrol / gadodiamide /  gadopentetic acid / gadoteric acid / gadoteridol /  gadoversetamide / gadoxetic acid

(updated)
07/12/2016Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201605
07/12/2016Agenda: Agenda - Adaptive pathways workshop (updated)
07/12/2016Human medicines European public assessment report (EPAR): Ninlaro,

ixazomib

Revision: 0, Authorised
07/12/2016Regulatory and procedural guideline: Procedural advice on the certification of quality and non-clinical data for small and medium-sized enterprises developing advanced therapy medicinal products , adopted (updated)
06/12/2016Referral: Article 31 referrals, Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions,

methylprednisolone

(updated)
06/12/2016Withdrawn application: Ertapenem Hospira,

ertapenem

Initial authorisation (updated)
06/12/2016Human medicines European public assessment report (EPAR): Sivextro,

tedizolid phosphate

Revision: 5, Authorised
05/12/2016Patient registries workshop, European Medicines Agency, London, UK, From: 28-Oct-2016, To: 28-Oct-2016 (updated)
05/12/2016Human medicines European public assessment report (EPAR): Portrazza,

necitumumab

Revision: 2, Authorised
05/12/2016Spinal muscular atrophy workshop, European Medicines Agency, London, From: 11-Nov-2016, To: 11-Nov-2016 (updated)
05/12/2016Human medicines European public assessment report (EPAR): Invirase,

saquinavir

Revision: 43, Authorised
05/12/2016Twelfth joint EMA/EUnetHTA dialogue meeting, European Medicines Agency, London, UK, From: 07-Dec-2016, To: 07-Dec-2016
05/12/2016Orphan designation:

Exon-55-specific phosphorothioate oligonucleotide

for the: Treatment of Duchenne muscular dystrophy (updated)
05/12/2016Orphan designation:

Exon-52-specific phosphorothioate oligonucleotide

for the: Treatment of Duchenne muscular dystrophy (updated)
05/12/2016Orphan designation:

Exon-53-specific phosphorothioate oligonucleotide

for the: Treatment of Duchenne muscular dystrophy (updated)
05/12/2016Orphan designation:

Exon-45-specific phosphorothioate oligonucleotide

for the: Treatment of Duchenne muscular dystrophy (updated)
05/12/2016Orphan designation:

2'-O-methyl phosphorothioate RNA oligonucleotide, 5'-m5CUGm5CUGm5CUGm5CUGm5CUGm5CUGm5CUG-3'

for the: Treatment of Huntington's disease (updated)
02/12/2016Orphan designation:

Exon 44 specific phosphorothioate oligonucleotide

for the: Treatment of Duchenne muscular dystrophy (updated)
02/12/2016Human medicines European public assessment report (EPAR): Invanz,

ertapenem

Revision: 19, Authorised
02/12/2016Organisation chart: Inspections, Human Medicines Pharmacovigilance and Committees Division (updated)
02/12/2016Herbal medicinal products: Harpagophytum , Harpagophyti radix, Harpagophytum procumbens DC.; Harpagophytum zeyheri Decne (updated)
02/12/2016Herbal medicinal products: Origanum, Origani majoranae herba, Origanum majorana L. (updated)
02/12/2016Herbal medicinal products: Arnica, Arnicae flos, Arnica montana L. (updated)
02/12/2016Human medicines European public assessment report (EPAR): Signifor,

pasireotide

Revision: 8, Authorised
02/12/2016News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November - 1 December 2016
02/12/2016News and press releases: PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C
02/12/2016Referral: Article 20 procedures, Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free),

daclatasvir / dasabuvir / sofosbuvir / ledipasvir / simeprevir / ombitasvir/paritaprevir / ritonavir

(updated)
02/12/2016Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue,

methylthioninium chloride

Revision: 15, Authorised
02/12/2016Human medicines European public assessment report (EPAR): Thymanax,

agomelatine

Revision: 15, Authorised
02/12/2016Referral: Article 31 referrals, Retinoid-containing medicinal products,

acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tretinoin, tazarotene

(updated)
02/12/2016List of the recruitment agencies used by the European Medicines Agency for interim staff (updated)
01/12/2016Regulatory and procedural guideline: Recommended submission dates for centralised and maximum-residue-limit procedures (updated)
01/12/2016News and press releases: Simpler website navigation for regulatory information on human medicines
01/12/2016Request for a joint ECDC, EFSA and EMA scientific opinion on a list of outcome indicators as regards surveillance of antimicrobial resistance and antimicrobial consumption in humans and food producing animals
01/12/2016Human medicines European public assessment report (EPAR): Descovy,

emtricitabine / tenofovir alafenamide

Revision: 1, Authorised
01/12/2016Antimicrobial resistance (updated)
01/12/2016News and press releases: Workshop on adaptive pathways – discussion on development approach for medicines addressing unmet medical needs
01/12/2016Advanced therapy classification (updated)
01/12/2016Human medicines European public assessment report (EPAR): Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 4, Authorised
01/12/2016Implementation of ISO IDMP standards (updated)
01/12/2016Organisation Management Services OMS operating model
01/12/2016SPOR data management services high level changes
01/12/2016Introduction to ISO Identification of Medicinal Products, SPOR programme
01/12/2016Referentials Management Services RMS operating model
01/12/2016Transition plan from Article 57 and XEVMPD data submission to SPOR
01/12/2016News and press releases: Kaisa Immonen elected as new co-chair of Patients’ and Consumers’ Working Party
01/12/2016Patients' and Consumers' Working Party (updated)