International non-proprietary name (INN)

linaclotide

Marketing-authorisation applicant

Almirall, SA.

Therapeutic indication

Treatment of irritable bowel syndrome

More information

Summary of opinion for Constella

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

International non-proprietary name (INN)

aflibercept

Marketing-authorisation applicant

Bayer Pharma AG

Therapeutic indication

Treatment of neovascular (wet) age-related macular degeneration

More information

Summary of opinion for Eylea

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

Summary of opinion for NexoBrid

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

International non-proprietary name (INN)

ingenol mebutate

Marketing-authorisation applicant

LEO Pharma A/S

Therapeutic indication

Treatment of actinic keratosis

More information

Summary of opinion for Picato

International non-proprietary name (INN)

memantine

Marketing-authorisation applicant

Merz Pharmaceuticals GmbH

Therapeutic indication

Treatment of Alzheimer’s disease

More information

Summary of opinion for Memantine Merz

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

Summary of opinion for Eliquis

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 VEGF inhibitors or VEGF receptor–targeted agents.

More information

Summary of opinion for Avastin

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

Summary of opinion for Cialis

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

Summary of opinion for Komboglyze

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:

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

Summary of opinion for Trajenta

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

Summary of opinion for Viread

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.

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

Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC).

Votubia is indicated for the treatment of patients aged 3 years and older with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (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

Summary of opinion for Votubia

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:

– 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

Summary of opinion for Eucreas
Summary of opinion for Icandra
Summary of opinion for Zomarist

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

Summary of opinion for Galvus
Summary of opinion for Jalra
Summary of opinion for Xiliarx

International non-proprietary name (INN)

dronedarone

Marketing-authorisation holder

Sanofi

Contraindications
(changes in bold)

– Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
– Second- or third- degree Atrio-Ventricular 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 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 hemodynamic 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 P 450 (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

Summary of opinion for MULTAQ

International non-proprietary name (INN)

capecitabine

Marketing-authorisation applicant

medac Gesellschaft für klinische Spezialpräparate mbH

Therapeutic indication

Treatment of colon cancer

More information

Summary of opinion for Capecitabine medac

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

Summary of opinion for Zoledronic Acid Hospira

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures

Opinions on safety variations

Start of community reviews

Scientific advice and protocol assistance

Guidelines and concept papers adopted during the September 2012 CHMP meeting

Overview of invented names reviewed in September 2012 by the Name Review Group (NRG)

Organisational matters