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MHRA approves for Epidyolex® (cannabidiol) for TSC seizure treatment

MHRA approves for Epidyolex® (cannabidiol) for TSC seizure treatment
europeanpharmaceuticalreview.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from europeanpharmaceuticalreview.com Daily Mail and Mail on Sunday newspapers.

United Kingdom , Northern Ireland , Chris Tovey , United Kingdom National Institute Of Health , European Commission , Jazz Pharmaceuticals , Drug Administration , Gw Pharmaceuticals , Regulatory Agency , European Union , European Medicines Agency , Executive Vice President , Reliance Procedure , National Institute , Care Excellence , ஒன்றுபட்டது கிஂக்டம் , வடக்கு ஐயர்ல்யாஂட் , கிறிஸ் டோவீ , ஒன்றுபட்டது கிஂக்டம் தேசிய நிறுவனம் ஆஃப் ஆரோக்கியம் , ஐரோப்பிய தரகு , ஜாஸ் மருந்துகள் , க்வ் மருந்துகள் , ஐரோப்பிய தொழிற்சங்கம் , நிர்வாகி துணை ப்ரெஸிடெஂட் , நம்பகத்தன்மை ப்ரொஸீஜர் , தேசிய நிறுவனம் ,

Celltrion secures EU approval for its adalimumab biosimilar

Celltrion secures EU approval for its adalimumab biosimilar
Celltrion’s adalimumab biosimilar, Yuflyma (CT-P17) has been approved by the European Commission for the treatment of multiple chronic inflammatory diseases, including rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis.
CT-P17 is the first approved adalimumab biosimilar in the EU with a high concentration, low-volume, and citrate-free formulation. Such formulations area said to reduce injection discomfort.
The EC approval of Yuflyma follows the recommendation for marketing authorization issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in December last year.
In terms of the administration device, Dr HoUng Kim, head of the medical and marketing division at Celltrion Healthcare, said the South Korean company looked to ensure improved convenience for patients in terms of the administration device - i ....

South Korea , United Kingdom , South Korean , European Medicines Agency , Drug Administration , Centre For Biosimilars , Committee For Medicinal Products Human Use , Medicinal Products , Human Use , Celltrion Healthcare , Reliance Procedure , Markets Amp Regulations , தெற்கு கொரியா , ஒன்றுபட்டது கிஂக்டம் , தெற்கு கொரியன் , குழு க்கு மருத்துவ ப்ராடக்ட்ஸ் மனிதன் பயன்பாடு , மருத்துவ ப்ராடக்ட்ஸ் , மனிதன் பயன்பாடு , நம்பகத்தன்மை ப்ரொஸீஜர் , சந்தைகள் ஆம்ப் ஒழுங்குமுறைகள் ,

Celltrion Healthcare receives European Commission (EC) approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab, YuflymaTM (CT-P17)

Celltrion Healthcare receives European Commission (EC) approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab, YuflymaTM (CT-P17)
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United Kingdom , Rieke Alten , Donna Curran , L Adalimumab Biosimilar , European Union , European Medicines Agency , European Commission , Head Of The Department Internal Medicine , Committee For Medicinal Products Human Use , Marketing Division At Celltrion Healthcare , Medicinal Products , Human Use , Houng Kim , Marketing Division , Internal Medicine , Clinical Immunology , Teaching Hospital , European Economic Area , Reliance Procedure , Proposed High Concentration , Adalimumab Biosimilar , Reference Adalimumab , Moderate To Severe Active Rheumatoid , Poster Presented , Crohns Disease , Marketing Authorisation ,

Apply for a licence to market a medicine in the UK

Apply for a licence to market a medicine in the UK
How to license a medicine for sale in the UK, including applications through national and international routes.
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This guidance also covers licensing a medicine in Northern Ireland through the centralised, decentralised and mutual recognition European procedures.
Which procedure to follow
There are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) or Northern Ireland. The options available will be determined by the intended market and the type of application. The markets in which each route is applicable are indicated in the following guidance: ....

United Kingdom , Northern Ireland , Great Britain , Canada Health , Committee For Medicinal Products , National Health Service , Regulatory Authority , National Rules Scheme , Department Of Health , European Union , Swiss Agency For Therapeutic Products Of Switzerland , Scottish Medicines Consortium , Food Branch , European Commission , Drug Administration , National Institute Of Heath Research , Council Of Europe , Community Procedures , Health Products , Group For Mutual Recognition , National Institute For Health , Health Research Authority , National Procedure , Health Sciences Authority , Access Consortium , Commission On Human Medicines ,