Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2012
At the start of its September 2012 meeting, the Committee for Medicinal Products for Human Use (CHMP) elected Tomas Salmonson as its new chair for a three-year mandate.
Dr Salmonson brings outstanding experience and expertise from a long career in the regulation of medicines both on a national and European level to his new role. A pharmacist by training, he is currently senior scientific advisor at the Swedish Medical Products Agency (MPA). He has been a member of the CHMP for more than 12 years.
The opinions adopted by the CHMP at the September 2012 meeting and other important outcomes are listed in the table below.
The Agency publishes a new page following each month's CHMP meeting.
Positive recommendations on new medicines
Name of medicine | BindRen |
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International non-proprietary name (INN) | colestilan |
Marketing-authorisation applicant | Mitsubishi Pharma Europe Ltd. |
Therapeutic indication | Treatment of hyperphosphataemia in adult patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis |
More information |
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Name of medicine | Constella |
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International non-proprietary name (INN) | linaclotide |
Marketing-authorisation applicant | Almirall, SA. |
Therapeutic indication | Treatment of irritable bowel syndrome |
More information |
Name of medicine | Eylea |
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International non-proprietary name (INN) | aflibercept |
Marketing-authorisation applicant | Bayer Pharma AG |
Therapeutic indication | Treatment of neovascular (wet) age-related macular degeneration |
More information |
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Name of medicine | NexoBrid |
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International non-proprietary name (INN) | concentrate of proteolytic enzymes enriched in bromelain |
Marketing-authorisation applicant | Teva Pharma GmbH |
Therapeutic indication | Removal of eschar |
More information |
Name of medicine | Picato |
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International non-proprietary name (INN) | ingenol mebutate |
Marketing-authorisation applicant | Leo Pharma A/S |
Therapeutic indication | Treatment of actinic keratosis |
More information |
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Positive recommendation on a new informed-consent application
Name of medicine | Memantine Merz |
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International non-proprietary name (INN) | memantine |
Marketing-authorisation applicant | Merz Pharmaceuticals GmbH |
Therapeutic indication | Treatment of Alzheimer's disease |
More information |
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Positive recommendations on extensions of therapeutic indications
Name of medicine | Eliquis |
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International non-proprietary name (INN) | apixaban |
Marketing-authorisation holder | Bristol-Myers Squibb / Pfizer EEIG |
New therapeutic indication | The CHMP adopted a new indication, prevention of stroke and systemic embolism in certain adult patients, and two new contraindications. |
More information |
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Name of medicine | Avastin |
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International non-proprietary name (INN) | bevacizumab |
Marketing-authorisation holder | Roche Registration Ltd |
New therapeutic indication | Bevacizumab, in combination with carboplatin and gemcitabine, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelian ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular-endothelial-growth-factor (VEGF) inhibitors or VEGF receptor–targeted agents. |
More information |
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Name of medicine | Cialis |
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International non-proprietary name (INN) | tadalafil |
Marketing-authorisation holder | Eli Lilly Nederland B.V. |
Therapeutic indication (changes in bold) | Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required. Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males. Cialis is not indicated for use by women. |
More information |
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Name of medicine | Komboglyze |
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International non-proprietary name (INN) | saxagliptin / metformin hydrochloride |
Marketing-authorisation holder | Bristol-Myers Squibb / AstraZeneca EEIG |
Therapeutic indication (changes in bold) | Komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets. Komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control. |
More information |
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Name of medicine | Trajenta |
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International non-proprietary name (INN) | linagliptin |
Marketing-authorisation holder | Boehringer Ingelheim International GmbH |
Therapeutic indication (changes in bold) | Trajenta is indicated in the treatment of type-2 diabetes mellitus to improve glycaemic control in adults:
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More information |
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Name of medicine | Viread |
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International non-proprietary name (INN) | tenofovir disoproxil (as fumarate) |
Marketing-authorisation holder | Gilead Sciences International Ltd |
Therapeutic indication | Please refer to the summary of opinion for all changes. |
More information |
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Name of medicine | Votubia |
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International non-proprietary name (INN) | everolimus |
Marketing-authorisation holder | Novartis Europharm Ltd |
Therapeutic indication (changes in bold) | Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)
Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.
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More information |
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Name of medicine | Eucreas / Icandra / Zomarist |
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International non-proprietary name (INN) | vildagliptin / metformin hydrochloride |
Marketing-authorisation holder | Novartis Europharm Ltd |
Therapeutic indication (changes in bold) | Vildagliptin / metformin hydrochloride is indicated in the treatment of type-2 diabetes mellitus:
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More information |
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Name of medicine | Galvus / Jalra / Xiliarx |
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International non-proprietary name (INN) | vildagliptin |
Marketing-authorisation holder | Novartis Europharm Ltd |
Therapeutic indication (changes in bold) | Vildagliptin is indicated in the treatment of type-2 diabetes mellitus in adults:
Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control. |
More information |
Positive recommendation on a new contraindication
Name of medicine | Multaq |
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International non-proprietary name (INN) | dronedarone |
Marketing-authorisation holder | Sanofi |
Contraindications (changes in bold) |
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More information |
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Positive recommendations on new generic medicines
Name of medicine | Capecitabine Medac |
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International non-proprietary name (INN) | capecitabine |
Marketing-authorisation applicant | Medac Gesellschaft für klinische Spezialpräparate mbH |
Therapeutic indication | Treatment of colon cancer |
More information |
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Name of medicine | Ibandronic acid Accord |
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International non-proprietary name (INN) | ibandronic acid |
Marketing-authorisation applicant | Accord Healthcare Limited |
Therapeutic indication | Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases, and treatment of tumour-induced hypercalcaemia with or without metastases. |
More information |
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Name of medicine | Zoledronic Acid Hospira |
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International non-proprietary name (INN) | zoledronic acid |
Marketing-authorisation applicant | Hospira UK Ltd |
Therapeutic indication | Prevention of skeletal related events and treatment of tumour-induced hypercalcaemia |
More information |
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Opinion on safety issue
Medicines studied at Texas-based Cetero Research facility |