Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2013

News 26/04/2013

This page provides an overview of the opinions adopted at the April 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

Seven new medicines recommended for approval

The Committee recommended the approval of the first combined tissue-engineered medicine to be authorised across the European Union (EU). Maci (matrix-induced autologous chondrocyte implantation) is an advanced-therapy medicinal product (ATMP) intended for the repair of cartilage defects.

The Committee also gave a positive recommendation for the approval of Nuedexta, the first medicine for pseudobulbar affect approved in the EU.

Four medicines to treat cancer received a positive opinion by the Committee: Erivedge, for the treatment of advanced basal-cell carcinoma; Xtandi, for the treatment of prostate cancer and the two generic medicines Capecitabine Sun and Imatinib Accord.

The CHMP also recommended that Spedra should be granted a marketing authorisation for the treatment of erectile dysfunction.

Negative opinion for Xeljanz

The Committee adopted a negative opinion for Xeljanz for the treatment of adult patients with moderate to severe active rheumatoid arthritis.

Two recommendations for extensions of indication

The CHMP recommended an extension of the existing indication for Revlimid and also for RoActemra.

CHMP confirms recommendation to restrict use of Protelos / Osseor

The Committee has recommended a restriction in the use of the osteoporosis medicine Protelos / Osseor, following an assessment of data showing an increased risk of serious heart problems.

Update on shortages

The shortage of Caelyx, a medicine for the treatment of breast cancer, ovarian cancer, progressive multiple myeloma and AIDS-related Kaposi's sarcoma, has been resolved.

A shortage of Increlex has been reported. This is a medicine used for the treatment of patients aged two to 18 years who are short for their age due to a condition known as 'severe primary insulin-like-growth-factor-1 deficiency'; information on how to deal with the shortage will be sent to healthcare professionals in a direct healthcare professional communication (DHPC).

More information on these and all other outcomes of the CHMP April 2013 meeting is available in the table below.


Positive recommendations on new medicines

Name of medicine Erivedge
International non-proprietary name (INN) vismodegib
Marketing-authorisation applicant Roche Registration Ltd
Therapeutic indication Treatment of advanced basal-cell carcinoma
More information PDF icon Summary of opinion for Erivedge

Name of medicine Maci
Common name matrix applied characterised autologous cultured chondrocytes
Marketing-authorisation applicant Genzyme Europe B.V.
Therapeutic indication Repair of symptomatic cartilage defects of the knee
More information

PDF icon Summary of opinion for Maci


Press release: European Medicines Agency recommends approval of combined advanced-therapy product

Name of medicine Nuedexta
INN dextromethorphan hydrobromide / quinidine sulfate
Marketing-authorisation applicant Jenson Pharmaceutical Services Ltd
Therapeutic indication Treatment of pseudobulbar affect
More information

PDF icon Summary of opinion for Nuedexta


Press release: European Medicines Agency recommends approval of first treatment for pseudobulbar affect

Name of medicine Spedra
INN avanafil
Marketing-authorisation applicant Vivus B.V.
Therapeutic indication Treatment of erectile dysfunction
More information PDF icon Summary of opinion for Spedra

Name of medicine Xtandi
INN enzalutamide
Marketing-authorisation applicant Astellas Pharma Europe B.V.
Therapeutic indication Treatment of prostate cancer
More information PDF icon Summary of opinion for Xtandi

Negative recommendations on new medicines

Name of medicine Xeljanz
INN tofacitinib citrate
Marketing-authorisation applicant Pfizer Ltd
Therapeutic indication Treatment of moderate to severe active rheumatoid arthritis
More information PDF icon Questions and answers on the refusal of the marketing authorisation for Xeljanz

Positive recommendations on new generic medicines

Name of medicine Capecitabine Sun
INN capecitabine
Marketing-authorisation applicant Sun Pharmaceutical Industries Europe B.V.
Therapeutic indication Treatment of cancer
More information PDF icon Summary of opinion for Capecitabine Sun

Name of medicine Imatinib Accord
INN imatinib
Marketing-authorisation applicant Accord Healthcare Ltd
Therapeutic indication Treatment of leukaemia
More information PDF icon Summary of opinion for Imatinib Accord



Positive recommendations on extensions of therapeutic indications

Name of medicine Revlimid
INN lenalidomide
Marketing-authorisation holder Celgene Europe Ltd
Change to a therapeutic indication
(changes in bold)

Multiple myeloma

Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.


Myelodysplastic syndromes


Revlimid is indicated for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

More information PDF icon Summary of opinion for Revlimid

Name of medicine RoActemra
INN tocilizumab
Marketing-authorisation holder Roche Registration Ltd
New therapeutic indication RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (rheumatoid-factor-positive or -negative and extended oligoarthritis) in patients two years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
More information PDF icon Summary of opinion for RoActemra



Recommendations for new contraindications

Name of medicine Pradaxa
INN dabigatran etexilate
Marketing-authorisation holder Boehringer Ingelheim International GmbH
Change to contraindication
(changes in bold)
Lesion or condition, if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
More information PDF icon Summary of opinion for Pradaxa

Name of medicine Kinzalkomb
INN telmisartan / hydrochlorothiazide
Marketing-authorisation holder Bayer Pharma AG
New contraindication The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR 60 ml/min/1.73 m2sup>) (see sections 4.2, 4.4, 4.5).
More information PDF icon Summary of opinion for Kinzalkomb

Name of medicine Kinzalmono
INN telmisartan
Marketing-authorisation holder Bayer Pharma AG
New contraindication The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5).
More information PDF icon Summary of opinion for Kinzalmono

Name of medicine Micardis
INN telmisartan
Marketing-authorisation holder Boehringer Ingelheim International GmbH
New contraindication The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5).
More information PDF icon Summary of opinion for Micardis

Name of medicine MicardisPlus
INN telmisartan / hydrochlorothiazide
Marketing-authorisation holder Boehringer Ingelheim International GmbH
New contraindication The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5).
More information PDF icon Summary of opinion for MicardisPlus

Name of medicine Onduarp
INN telmisartan / amlodipine
Marketing-authorisation holder Boehringer Ingelheim International GmbH
New contraindication The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5).
More information PDF icon Summary of opinion for Onduarp

Name of medicine Pritor
INN telmisartan
Marketing-authorisation holder Bayer Pharma AG
New contraindication

The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5).

More information PDF icon Summary of opinion for Pritor

Name of medicine PritorPlus
INN telmisartan / hydrochlorothiazide
Marketing-authorisation holder Bayer Pharma AG
New contraindication The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5).
More information PDF icon Summary of opinion for PritorPlus

Name of medicine Twynsta
INN telmisartan / amlodipine
Marketing-authorisation holder Boehringer Ingelheim International GmbH
New contraindication The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5).
More information PDF icon Summary of opinion for Twynsta



Final opinions on other variations

Name of medicine Exjade
INN deferasirox
Marketing-authorisation holder Novartis Europharm Ltd
More information PDF icon Questions and answers on the outcome of extension of indication application for Exjade

Name of medicine Menveo
Common name meningococcal group A, C, W-135 and Y conjugate vaccine
Marketing-authorisation holder Novartis Vaccines and Diagnostics S.r.l.
More information PDF icon Questions and answers on outcome of application to extend use of Menveo in children less than two years



Withdrawal of application

Name of medicine Raxone
INN idebenone
More information Raxone: Withdrawn application



Supply shortages

Name of medicine Caelyx
INN doxorubicin
Marketing-authorisation holder Janssen-Cilag International N.V.
More information PDF icon Questions and answers on the supply situation of Caelyx

Name of medicine Increlex
INN mecasermin
Marketing-authorisation holder Ipsen Pharma
More information PDF icon Questions and answers on the shortage of Increlex



Public health communication

Recommendation to restrict the use of Protelos / Osseor (strontium ranelate)


Other updates

PDF icon Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF icon Opinions on safety variations
Start of Community reviews
PDF icon Scientific advice and protocol assistance
PDF icon Guidelines and concept papers adopted
PDF icon Overview of invented names reviewed in March 2013 by the Name Review Group (NRG)
PDF icon Organisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

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