Some combinations no longer recommended; careful monitoring required The European Medicines Agency has recommended updating the prescribing information for Victrelis (boceprevir) with information about drug interactions between this hepatitis C medicine and the ritonavir-boosted HIV protease inhibitors atazanavir, darunavir and lopinavir. A drug interaction study in healthy volunteers carried out by Merck Sharp and Dohme, [...]

The European Medicines Agency has been formally notified by GlaxoSmithKline Research & Development of its decision to withdraw its application for an extension of the therapeutic indication for the centrally authorised medicine Tyverb (lapatinib), 250 mg film-coated tablets. On 14 April 2011, GlaxoSmithKline submitted an application to extend the marketing authorisation for Tyverb in combination [...]

Agrees with World Health Organization recommendations for ethambutol, isoniazid, pyrazinamide and rifampicin The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded its review of dosing recommendations from the World Health Organization (WHO) for first-line anti-tuberculosis medicines in children. While the Committee acknowledged that the dosing regimen of first-line anti-tuberculosis therapies [...]

Company to supply additional data on patients pretreated with rituximab The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Pixuvri be granted conditional approval for the cancer non-Hodgkin’s B-cell lymphoma. The new medicine, which contains the active substance pixantrone, is to be used on its own in patients whose [...]

Review finds that benefits of all antifibrinolytic medicines outweigh risks in restricted range of indications The European Medicines Agency has recommended that the suspension of the marketing authorisations for aprotinin-containing medicines in the European Union (EU) be lifted. This follows a full review of the benefits and risks of all antifibrinolytic medicines, which found that [...]

European Medicines Agency’s opinion intended to support countries outside the European Union to get new treatment option to market to fight World Health Organization target disease The European Medicines Agency has recommended Pyramax, a fixed combination consisting of pyronaridine and artesunate, an artemisinin derivative, from Shin Poong Pharmaceutical Co. Ltd, for the treatment of acute, [...]

Combination of aliskiren with ‘ACE’ inhibitors and ‘ARBs’ no longer recommended for patients; contraindications in patients with diabetes or kidney problems The European Medicines Agency finalised a review of aliskiren-containing medicines, recommending that these medicines should be contraindicated in patients with diabetes or moderate to severe renal impairment who take angiotensin converting enzyme (ACE) inhibitors [...]

Data to be made public from 1 March 2012 From Thursday 1 March 2012, the European Medicines Agency will start to publish information on applications for centralised marketing authorisation for human medicines that it has received for evaluation. The Agency will publish the international non-proprietary names (INN) and therapeutic areas for all new innovative medicines [...]

Existing information on potential very rare liver-related side effects to be harmonised Finalising its review on orlistat-containing medicines and the possible risk of severe liver injuries, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefit of these medicines continue to outweigh their risks in the treatment of [...]

Final recommendations confirm interim advice given; medicines can continue to be prescribed as previously Continuing its review on the shortcomings in quality assurance identified at Ben Venue Laboratories, Ohio, United States, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has confirmed its initial advice and given final recommendations for 12 out [...]