Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2012

News 21/09/2012

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 medicineBindRen
International non-proprietary name (INN)colestilan
Marketing-authorisation applicantMitsubishi Pharma Europe Ltd.
Therapeutic indicationTreatment of hyperphosphataemia in adult patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis
More information PDF iconSummary of opinion for BindRen

Name of medicineConstella
International non-proprietary name (INN)linaclotide
Marketing-authorisation applicantAlmirall, SA.
Therapeutic indicationTreatment of irritable bowel syndrome
More information

PDF iconSummary of opinion for Constella


Press release: European Medicines Agency recommends authorisation of first medicine specifically for irritable bowel syndrome

Name of medicineEylea
International non-proprietary name (INN)aflibercept
Marketing-authorisation applicantBayer Pharma AG
Therapeutic indicationTreatment of neovascular (wet) age-related macular degeneration
More information PDF iconSummary of opinion for Eylea

Name of medicineNexoBrid
International non-proprietary name (INN)concentrate of proteolytic enzymes enriched in bromelain
Marketing-authorisation applicantTeva Pharma GmbH
Therapeutic indicationRemoval of eschar
More information

PDF iconSummary of opinion for NexoBrid


Press release: European Medicines Agency recommends first medical treatment for removal of eschar from severe burn wounds

Name of medicinePicato
International non-proprietary name (INN)ingenol mebutate
Marketing-authorisation applicantLeo Pharma A/S
Therapeutic indicationTreatment of actinic keratosis
More information PDF iconSummary of opinion for Picato

Positive recommendation on a new informed-consent application

Name of medicineMemantine Merz
International non-proprietary name (INN)memantine
Marketing-authorisation applicantMerz Pharmaceuticals GmbH
Therapeutic indicationTreatment of Alzheimer's disease
More information PDF iconSummary of opinion for Memantine Merz

Positive recommendations on extensions of therapeutic indications

Name of medicineEliquis
International non-proprietary name (INN)apixaban
Marketing-authorisation holderBristol-Myers Squibb / Pfizer EEIG
New therapeutic indicationThe CHMP adopted a new indication, prevention of stroke and systemic embolism in certain adult patients, and two new contraindications.
More information PDF iconSummary of opinion for Eliquis

Name of medicineAvastin
International non-proprietary name (INN)bevacizumab
Marketing-authorisation holderRoche Registration Ltd
New therapeutic indicationBevacizumab, 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 PDF iconSummary of opinion for Avastin

Name of medicineCialis
International non-proprietary name (INN)tadalafil
Marketing-authorisation holderEli 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 PDF iconSummary of opinion for Cialis

Name of medicineKomboglyze
International non-proprietary name (INN)saxagliptin / metformin hydrochloride
Marketing-authorisation holderBristol-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 PDF iconSummary of opinion for Komboglyze

Name of medicineTrajenta
International non-proprietary name (INN)linagliptin
Marketing-authorisation holderBoehringer 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:

  • as monotherapy:
    • in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment;
  • as combination therapy:
    • in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control;
    • in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control;
    • in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
More information PDF iconSummary of opinion for Trajenta

Name of medicineViread
International non-proprietary name (INN)tenofovir disoproxil (as fumarate)
Marketing-authorisation holderGilead Sciences International Ltd
Therapeutic indicationPlease refer to the summary of opinion for all changes.
More information PDF iconSummary of opinion for Viread

Name of medicineVotubia
International non-proprietary name (INN)everolimus
Marketing-authorisation holderNovartis 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.


The evidence is based on analysis of change in sum of angiomyolipoma volume.


Subependymal giant cell astrocytoma (SEGA) associated with TSC.


Votubia is indicated for the treatment of patients aged 3 years and older with SEGA associated with TSC who require therapeutic intervention but are not amenable to surgery.


The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease-related symptoms, has not been demonstrated.

More information PDF iconSummary of opinion for Votubia

Name of medicineEucreas / Icandra / Zomarist
International non-proprietary name (INN)vildagliptin / metformin hydrochloride
Marketing-authorisation holderNovartis Europharm Ltd
Therapeutic indication
(changes in bold)

Vildagliptin / metformin hydrochloride is indicated in the treatment of type-2 diabetes mellitus:

  • in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets;
  • in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulphonylurea;
  • in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
More information

PDF iconSummary of opinion for Eucreas

PDF iconSummary of opinion for Icandra

PDF iconSummary of opinion for Zomarist

Name of medicineGalvus / Jalra / Xiliarx
International non-proprietary name (INN)vildagliptin
Marketing-authorisation holderNovartis Europharm Ltd
Therapeutic indication
(changes in bold)

Vildagliptin is indicated in the treatment of type-2 diabetes mellitus in adults:

  • as monotherapy:
    • in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;
  • as dual oral therapy in combination with:
    • metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;
    • a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance;
    • a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate;
  • as triple oral therapy in combination with:
    • a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.

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

PDF iconSummary of opinion for Galvus

PDF iconSummary of opinion for Jalra

PDF iconSummary of opinion for Xiliarx

Positive recommendation on a new contraindication

Name of medicineMultaq
International non-proprietary name (INN)dronedarone
Marketing-authorisation holderSanofi
Contraindications
(changes in bold)
  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
  • Second- or third-degree atrioventricular block, complete bundle branch block, distal block, sinus node dysfunction, atrial conduction defects, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker).
  • Bradycardia 50 beats per minute (bpm).
  • Permanent atrial fibrillation (AF) with an AF duration ≥6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician.
  • Patients in unstable haemodynamic conditions.
  • History of or current heart failure or left ventricular systolic dysfunction.
  • Patients with liver and lung toxicity related to the previous use of amiodarone.
  • Co-administration with potent cytochrome P450 (CYP) 3A4 inhibitors, such as ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone and ritonavir.
  • Medicinal products inducing torsades de pointes such as phenothiazines, cisapride, bepridil, tricyclic antidepressants, terfenadine and certain oral macrolides (such as erythromycin), class I and III antiarrhythmics.
  • QTc Bazett interval ≥500 milliseconds.
  • Severe hepatic impairment.
  • Severe renal impairment (CrCl 30 ml/min).
  • Co-administration with dabigatran
More information PDF iconSummary of opinion for Multaq

Positive recommendations on new generic medicines

Name of medicineCapecitabine Medac
International non-proprietary name (INN)capecitabine
Marketing-authorisation applicantMedac Gesellschaft für klinische Spezialpräparate mbH
Therapeutic indicationTreatment of colon cancer
More information PDF iconSummary of opinion for Capecitabine Medac

Name of medicineIbandronic acid Accord
International non-proprietary name (INN)ibandronic acid
Marketing-authorisation applicantAccord Healthcare Limited
Therapeutic indicationPrevention 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 PDF iconSummary of opinion for Ibandronic acid Accord

Name of medicineZoledronic Acid Hospira
International non-proprietary name (INN)zoledronic acid
Marketing-authorisation applicantHospira UK Ltd
Therapeutic indicationPrevention of skeletal related events and treatment of tumour-induced hypercalcaemia
More information PDF iconSummary of opinion for Zoledronic Acid Hospira


Opinion on safety issue

Medicines studied at Texas-based Cetero Research facility


Other updates

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations
PDF iconStart of Community reviews
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted during the September 2012 CHMP meeting
Overview of invented names reviewed in September 2012 by the Name Review Group (NRG)
PDF iconOrganisational matters

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