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 |
Xtandi |
| INN |
enzalutamide |
| Marketing-authorisation applicant |
Astellas Pharma Europe B.V. |
| Therapeutic indication |
Treatment of prostate cancer |
| More information |
Summary of opinion for Xtandi
|
Negative recommendations on new medicines
Positive recommendations on new generic medicines
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Summary of opinion for Twynsta
|
Final opinions on other variations
Withdrawal of application
Supply shortages
Public health communication
Other updates
