European Medicines | The Truth About Skin Care

{ Tag Archives } European Medicines

Ipilimumab Receives FDA Priority Review Designation For Adult Patients With Previously Treated Advanced Melanoma

Main Category: Melanoma / Skin Cancer
Also Included In: Regulatory Affairs / Drug Approvals; Dermatology
Article Date: 20 Aug 2010 – 1:00 PDT

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Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted, for [...]

Also tagged Adequate Therapy, Adult Patients, American Society Of Clinical Oncology, Biologics License Application, Bmy, Bristol Myers, Bristol Myers Squibb, Bristol Myers Squibb Company, Ctla, England Journal Of Medicine, Fda Action, Food And Drug Administration, Food And Drug Administration Fda, Health Authorities, Medicines Agency, Myers Squibb Company, New England Journal, New England Journal Of Medicine, Rate Article

2010 08 20 Skin Care News Comments Off

European Medicines Agency Confirms Positive Benefit-Risk Balance Of Topical Formulations Of Ketoprofen

Main Category: Dermatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 23 Jul 2010 – 1:00 PDT

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Following a review of topical formulations of ketoprofen, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has [...]

Also tagged Binding Decision, Chmp, Drug Approvals, Eu Member States, Friendly View, Inflammatory Drug, Ketoprofen, Low Back Pain, Medicines Agency, Minor Trauma, Octocrylene, Photoallergy, Rate Article, Regulatory Affairs, Risk Minimisation, S Committee, Serious Skin, Sun Exposure, Sun Filter

2010 07 23 Skin Care News Comments Off

Clinuvel Unveils SCENESSE(R) Following European Brand Approval

Main Category: Dermatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 May 2010 – 15:00 PDT

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Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that the European Medicines Agency (EMA) Name Review Group (NRG) and the Agency’s Committee [...]

Also tagged Aifa, Biological Balance, Cell Survival, Clinuvel, Drug Approval Process, Drug Approvals, Erythropoietic Protoporphyria, Global Clinical Development, List Of Drugs, Medicines Agency, National Health System, New Skin, Programmed Cell Death, Rate Article, S Committee, Senescence, Skin Cells, Skin Diseases, Xetra Dax

2010 05 21 Skin Care News Comments Off

Clinuvel Unveils SCENESSE(R) Following European Brand Approval

Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that the European Medicines Agency (EMA) Name Review Group (NRG) and the Agency’s Committee for Human Medicinal Products (CHMP) has approved the company’s proposed trade name – SCENESSE® (pronounced “sen-esse”) – for its proprietary first-in-class medicinal photoprotective drug…

Also tagged Adr, Asx, Limited, Medicines Agency, Nrg, Pharmaceuticals, S Committee, Xetra Dax

2010 05 20 Skin Care News Comments Off

Arpida A/S Withdraws Its Marketing Authorisation Application For Mersarex (iclaprim), Europe

The European Medicines Agency has been formally notified by Arpida A/S of its decision to withdraw its application for a centralised marketing authorisation for the medicine Mersarex (iclaprim), 12.8 mg/ml concentrate for solution for infusion. Mersarex was expected to be used for the treatment of complicated skin and soft tissue infections. [...]

Also tagged Concentrate, Europe, Infusion, Marketing, Medicine, Medicines Agency, Ml, Soft Tissue Infections

2009 10 25 Skin Care News Comments Off

EMEA Grants Clinuvel New Orphan Drug – For Solar Urticaria – Designation

Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is pleased to announce that afamelanotide, its photoprotective drug, has been granted Orphan Medicinal Product (OMP) designation by the European Medicines Agency (EMEA) for the treatment of Solar Urticaria (SU). The EMEA granted afamelanotide its first OMP designation in March 2008 for the treatment of Erythropoietic [...]

Also tagged Adr, Asx, Clinical Trials, Clinuvel, Designation, Emea, Epp, Erythropoietic Protoporphyria, Grants, Lead, Limited, Medicines Agency, Orphan Drug, Pharmaceuticals, Phase Iii, Solar Urticaria, Urticaria, Xetra Dax

2009 06 19 Skin Care News Comments Off

CHMP Delays European Commission Decision Process To Approve ZEVTERATM

Janssen-Cilag announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has decided to delay the European Commission decision process on ZEVTERATM (ceftobiprole medocaril) pending completion of a Good Clinical Practice (GCP) inspection. ZEVTERA is in the final stage of approval for the treatment of complicated [...]

Also tagged Ceftobiprole, Chmp, Commission Decision, European Commission, Good Clinical Practice, Janssen Cilag, Medicines Agency, Soft Tissue Infections

2009 02 24 Skin Care News Comments Off

CHMP Delays European Commission Decision Process To Approve ZEVTERATM

Janssen-Cilag announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has decided to delay the European Commission decision process on ZEVTERATM (ceftobiprole medocaril) pending completion of a Good Clinical Practice (GCP) inspection. ZEVTERA is in the final stage of approval for the treatment of [...]

Also tagged Ceftobiprole, Chmp, Commission Decision, European Commission, Good Clinical Practice, Janssen Cilag, Medicines Agency, Soft Tissue Infections

2009 02 24 Skin Care News Comments Off

European Medicines Agency Recommends New Contraindication And Warning For Rasilez And Other Aliskiren Medicines

The European Medicines Agency (EMEA) has recommended adding a contra-indication to the Product Information for aliskiren, stating that it must not be used in patients who have experienced angioedema (swelling of the tissues beneath the skin) when taking aliskiren in the past. The Agency also recommended the [...]

Also tagged Aliskiren, Contraindication, Emea, Inclusion, Medical Attention, Medicines Agency, Product Information, Rasilez, Signs, Tissues

2009 02 20 Skin Care News Comments Off

European Medicines Agency Recommends Suspension Of The Marketing Authorisation Of Raptiva (efalizumab)

The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Raptiva (efalizumab), from Serono. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Raptiva no longer outweigh its risks, because of safety concerns, including the occurrence of progressive multifocal leukoencephalopathy (PML) in patients taking [...]

Also tagged Authorisation, Chmp, Efalizumab, Emea, Marketing, Medicine, Medicines Agency, Occurrence, Progressive Multifocal Leukoencephalopathy, Progressive Multifocal Leukoencephalopathy Pml, Raptiva, S Committee, Safety Concerns

2009 02 20 Skin Care News Comments Off

The Truth About Skin Care

{ Tag Archives } European Medicines

Ipilimumab Receives FDA Priority Review Designation For Adult Patients With Previously Treated Advanced Melanoma

European Medicines Agency Confirms Positive Benefit-Risk Balance Of Topical Formulations Of Ketoprofen

Clinuvel Unveils SCENESSE(R) Following European Brand Approval

Clinuvel Unveils SCENESSE(R) Following European Brand Approval

Arpida A/S Withdraws Its Marketing Authorisation Application For Mersarex (iclaprim), Europe

EMEA Grants Clinuvel New Orphan Drug – For Solar Urticaria – Designation

CHMP Delays European Commission Decision Process To Approve ZEVTERATM

CHMP Delays European Commission Decision Process To Approve ZEVTERATM

European Medicines Agency Recommends New Contraindication And Warning For Rasilez And Other Aliskiren Medicines

European Medicines Agency Recommends Suspension Of The Marketing Authorisation Of Raptiva (efalizumab)

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