CHMP and CMD news – December 2013
CMDh endorses PRAC recommendation about restriction of use of acipimox containing medicinal products
The CMDh has endorsed the PRAC recommendation about the restriction of use of apimox-containing medicinal products. The use of these medicinal products will be restricted to additional or alternative treatment of high triglyceride blood levels in patients with type IIb and IV hyperlipoproteinaemia. There are no authorised medicines in the Republic of Croatia with the aforementioned active substance. More information may be viewed on the EMA webpages, or here.
CHMP confirms PRAC recommendations on Kogenate Bayer and Helixate NexGen
The CHMP has confirmed recent PRAC recommendations for medicinal products Kogenate Bayer and Helixate NexGen. The PRAC has concluded that the benefits continue to outweigh the risks for Kogenate Bayer and Helixate Nexgen, which are second generation products of factor VIII in previously untreated patients with haemophilia A. More information may be seen on the EMA webpages or here.
CHMP recommends approval of a new medicine for multidrug-resistant
The CHMP has recommended granting a conditional marketing authorisation for Sirturo (bedaquiline) for use of multiresistant tuberculosis. It is foreseen that this medicinal product be used as part of a combination therapy for pulmonary multidrug-resistant tuberculosis in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. More information may be viewed on the EMA webpages, or here.
CHMP recommends approval of five new medicinal products
Except for granting a conditional marketing authorisation for medicinal product Sirturo (bedaquiline), the CHMP has endorsed recommendations for approval of the following medicinal products:
- conditional marketing authorisation for Cometriq (cabozantinib) for the treatment of medullary thyroid cancer, that you may read more about here.
- marketing authorisation for the medicinal product Izba (travoprost) for the treatment of ocular hypertension or open angle glaucoma, which you may read more about here.
- marketing authorisation for the medicinal product Mirvaso (brimonidine) for the treatment of facial erythema of rosacea in adult patients, which you may read more about here.
- marketing authorisation for Neuraceq [fluorbetaben (18F)] for imaging of beta-amiloid deposition in the brains of adult patients who are being evaluated for Alzheimer’s disease or other causes of cognitive impairement, which you may read more about here.
The CHMP adopted positive scientific opinion for Tritanrix HB
The medicinal product Tritanrix HB is intended for active immunisation of diphtheria, tetanus, pertussis and hepatitis B in infants from 6 weeks onwards. The marketing authorisation for this medicine will be terminated by the end of 2013 in the EU and by the procedure under Art 58 of the Regulation (EC) No 726/2004 the use of this medicine is ensured in countries outside the EU.
More information may be viewed on the EMA webpages or here.
The CHMP recommends restrictions for use of estradiol-containing creams (Linoladiol N and Linoladiol HN)
The CHMP has recommended restriction of use for estradiol-containing creams (Linoladiol N and Linoladiol HN). These creams contain relatively high estrogen concentration and therefore due to the risk of its systemic effect, the treatment is restricted to four weeks. Linoladiol N will be used for vaginal atrophy due to estrogen deficiency in women in which at least one medicine for local use containing a lower estrogen-concentration failed. The use of Linoladiol HN is restricted to treatment for mild inflammatory skin diseases of the external female genital area. More information may be viewed on the EMA webpages or here.
CHMP adopted new therapeutic indication for Jentadueto
The CHMP has adopted recommendations for variations to the term of marketing authorisation for Jentadueto (linagliptin/metformin), which you may read more about here.