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European CHMP recommends approval of Exparel (bupivacaine dispersion for injection) for treatment of post-operative pain

Remove: European Medicines Agency - EMA source - 18 September 2020 - Publisher: European Medicines Agency

Exparel is intended for use as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from...

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European CHMP recommends approval of MenQuadfi (meningococcal vaccine) for prophylaxis against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y

Remove: European Medicines Agency - EMA source - 18 September 2020 - Publisher: European Medicines Agency

MenQuadfi is intended for use for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and...

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European CHMP recommends approval of Obiltoxaximab SFL for treatment or post-exposure prophylaxis of inhalational anthrax

Remove: European Medicines Agency - EMA source - 18 September 2020 - Publisher: European Medicines Agency

Obiltoxaximab is a monoclonal antibody that binds to the protective antigen (PA) of Bacillus anthracis toxin, thereby inhibiting binding of PA to its cellular receptors and preventing intracellular...

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European CHMP recommends extension of delamanid (Deltyba) indication to include treatment of adolescents and children with weight ≥30 kg

Remove: European Medicines Agency - EMA source - 18 September 2020 - Publisher: European Medicines Agency

Deltyba is currently licensed for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults when an effective treatment regimen cannot...

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European CHMP recommends approval of use of perampanel in younger patients

Remove: European Medicines Agency - EMA source - 18 September 2020 - Publisher: European Medicines Agency

The CHMP has recommended the approval of its use from age 4 years for the partial-onset seizures indication and from 7 years for the primary generalised tonic-clonic indication (currently both are...

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European CHMP recommends approval of use of Flucelvax Tetra in a wider age range

Remove: European Medicines Agency - EMA source - 18 September 2020 - Publisher: European Medicines Agency

The CHMP has adopted a positive opinion, recommending that its use for the prophylaxis of influenza in adults and children be extended to include children from 2 years of age (currently 9 years).

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European CHMP recommends approval of extension to existing indication for Kalydeco (ivacaftor) and new tablet strength

Remove: European Medicines Agency - EMA source - 18 September 2020 - Publisher: European Medicines Agency

The CHMP has recommended the approval of a new 75mg strength for Kalydeco tablets and an extension to the existing indication in combination with Symkevi (tezacaftor/ivacaftor) to allow use in...

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European CHMP recommends approval of new indications for olaparib

Remove: European Medicines Agency - EMA source - 18 September 2020 - Publisher: European Medicines Agency

The CHMP has recommended the approval of olaparib as monotherapy for the treatment of adults with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who...

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European CHMP recommends approval of baricitinib for the treatment of moderate to severe atopic dermatitis in adults

Remove: European Medicines Agency - EMA source - 18 September 2020 - Publisher: European Medicines Agency

Baricitinib is currently approved in the EU to treat moderate to severe active rheumatoid arthritis in adults who have responded inadequately to, or who are intolerant to one or more...

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European CHMP recommends approval of an extension to the existing indication for nivolumab for non-small cell lung cancer

Remove: European Medicines Agency - EMA source - 18 September 2020 - Publisher: European Medicines Agency

The CHMP has recommended its approval for use in combination with ipilimumab and 2 cycles of platinum-based chemotherapy for the first-line treatment of metastatic NSCLC in adults whose tumours have...

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Results for all evidence | Drugs and Technologies | Medicines Current Awareness | European Medicines Agency - EMA 1 - 10 of 66 sorted by relevance / date

European CHMP recommends approval of Exparel (bupivacaine dispersion for injection) for treatment of post-operative pain

European CHMP recommends approval of MenQuadfi (meningococcal vaccine) for prophylaxis against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y

European CHMP recommends approval of Obiltoxaximab SFL for treatment or post-exposure prophylaxis of inhalational anthrax

European CHMP recommends extension of delamanid (Deltyba) indication to include treatment of adolescents and children with weight ≥30 kg

European CHMP recommends approval of use of perampanel in younger patients

European CHMP recommends approval of use of Flucelvax Tetra in a wider age range

European CHMP recommends approval of extension to existing indication for Kalydeco (ivacaftor) and new tablet strength

European CHMP recommends approval of new indications for olaparib

European CHMP recommends approval of baricitinib for the treatment of moderate to severe atopic dermatitis in adults

European CHMP recommends approval of an extension to the existing indication for nivolumab for non-small cell lung cancer