Category Archives: EMEA media releases

EMA: Use modafinil only for narcolepsy

The European Medicines Agency recommended restricting the use of modafinil for narcolepsy only.

The European Medicines Agency has recommended restricting the use of modafinil-containing medicines. The medicine should only be used to treat sleepiness associated with narcolepsy. Doctors and patients should no longer use the medicine for the treatment of idiopathic hypersomnia, excessive sleepiness associated with obstructive sleep apnoea and chronic shift work sleep disorder.”

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EMEA recommends new contraindication for aliskiren (Rasilez): angioedema

According to the EMEA, aliskiren (Rasilez, Tekturna in the USA) should not be prescribed in patients that experienced angioedema after taking the drug. Some excerpts from the EMEA press release dated 19 February, 2009: The European Medicines Agency (EMEA) has recommended adding a contraindication to the Product Information for aliskiren, stating that it must not…

Vorinostat MSD for cutaneous T-cell lymphoma. MSD withdraws marketing application

Excerpts from the EMEA press release (dated 17th February) on the withdrawal of the marketing application for Vorinostat MSD: The European Medicines Agency (EMEA) has been formally notified by Merck Sharp & Dohme Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Vorinostat MSD (vorinostat), 100 mg hard…

EMEA recommends new contraindications for toremifene (Fareston): long QT interval and related heart diseases

In a recent press release, EMEA made clear the new contraindications for the selective estrogen receptor modulator (SERM) toremifene (Fareston): Completing the review of the available data  during its 19-22 January 2009 meeting, the CHMP concluded that the benefits of Fareston are greater than its risks, but that its use should be restricted. The CHMP…

EMEA public statement on the market withdrawal of Daclizumab (Zenapax)

Daclizumab (Zenapax), a monoclonal antibody to the alpha subunit of the IL-2 receptor of T cells, has been withdrawn from the market in the European Union since Since 1 January 2009. According to an EMEA press release issued 16 January 2009: On 26 February 1999, the European Commission granted a marketing authorisation valid throughout the European Union…

Ramipril (Tritrace): indications, contraindications and posology updated in a review by the CHMP

The CHMP has issued a question and answer document dated 18 December 2008, about the review of Titrace (ramipril) and associated names: Questions and answers on the referral for Tritace tablet and hard capsules containing ramipril 1.25 mg, 2.5 mg, 5 mg and 10 mg The European Medicines Agency (EMEA) has completed a review of…Continue Reading

EMEA: marketing authorisation of Nespo (darbepoetin alfa) withdrawed

EMEA public statement dated 16 December 2008: PUBLIC STATEMENT ONNespo (darbepoetin alfa) WITHDRAWAL OF THE MARKETING AUTHORISATION IN THE EUROPEAN UNION On 8 June 2001 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Nespo, darbepoetin alfa, which had been approved for the treatment of symptomatic anaemia associated…Continue Reading

EMEA: marketing authorisation of Neupopeg (pegfilgrastim) withdrawed

Public statement dated 16 December 2008: PUBLIC STATEMENT ON Neupopeg (pegfilgrastim) WITHDRAWAL OF THE MARKETING AUTHORISATION IN THE EUROPEAN UNION On 22 August 2002 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Neupopeg, pegfilgrastim, which had been approved for the reduction in the duration of neutropenia and the incidence…Continue Reading

EMEA press release: CHMP adopted positive opinion about mifamurtide (Mepact) for the treatment of osteosarcoma

EMEA press release informing the CHMP positive opinion about mifamurtide (Mepact), for the treatment of high grade resectable non metastatic osteosarcoma. COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION for MEPACT International Nonproprietary Name (INN): mifamurtide On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive…Continue Reading

EMEA press release: CHMP positive opinion about degarelix (Firmagon) for prostate cancer

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION for FIRMAGON International Nonproprietary Name (INN): degarelix (as acetate) On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing authorisation for the medicinal product Firmagon, 80 mg and 120 mg, powder and…Continue Reading

CHMP positive opinion for lasofoxifene (Fablyn), a new SERM

Press release about the positive opinion of the CHMP for Fablyn (lasofoxifene): COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE  SUMMARY OF POSITIVE OPINION for FABLYN International Nonproprietary Name (INN): lasofoxifene On 18 December 2008  the Committee for Medicinal Products  for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing authorisation for the…Continue Reading

CHMP positive opinion for new indication of miglustat (Zavesca)

Press release from the CHMP about a new indication for Zavesca (miglustat): COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE POST-AUTHORISATION SUMMARY OF POSITIVE OPINION for ZAVESCA International Nonproprietary Name (INN): miglustat On 18 December 2008  the Committee for Medicinal Products  for Human Use (CHMP) adopted a positive opinion  to  recommend the variation to the terms …Continue Reading

EMEA positive opinion for prasugrel (Efient)

Press release about the positive opinion of the CHMP for the antiplatelet agent Efient (prasugrel): COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION for EFIENT International Nonproprietary Name (INN): prasugrel On 18 December 2008  the Committee for Medicinal Products  for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing…Continue Reading

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