Category Archives: EMEA media releases

EMEA press release: CHMP adopted a positive opinion about japanese encephalitis vaccine (Ixiaro)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION for IXIARO Common Name: Japanese Encephalitis vaccine, inactivated, adsorbed 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 IXIARO, containing a target total protein amount ofContinue Reading

EMEA press release: CHMP adopted a positive opinion for pandemic influenza vaccine H5N1 (Celvapan)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE  SUMMARY OF POSITIVE OPINION for CELVAPAN Common Name: Pandemic Influenza Vaccine (H5N1 whole virion, Vero cell derived, inactivated) On 18 December 2008  the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion,  recommending the granting of a marketing authorisation for the medicinal product Celvapan, 7.5Continue Reading

Paliperidone (Invega) manufacturer withdraws application for its use in bipolar disorder

Reproduction of EMEA’s press release about the Janssen-Cilag International  application withdrawal for an extension of indication for Invega (paliperidone): PRESS RELEASE Janssen-Cilag International N.V. withdraws its application for an extension of indication for Invega (paliperidone) The European Medicines Agency (EMEA) has been formally notified by Janssen-Cilag International N.V. of its decision to withdraw its applicationContinue Reading

EMEA’s opinion to designate new orphan drugs

ORPHAN MEDICINAL PRODUCT DESIGNATION The COMP adopted six positive opinions recommending the following medicines for designation as orphan medicinal products to the European Commission: For the following medicines the EMEA review began on 12 September 2008 with an active review time of 90 days. Continue Reading

EMEA: Norfloxacin should not be used to treat acute or chronic complicated pyelonephritis

This press release was published on July 2008: EMEA recommends restricted use of oral norfloxacin-containing medicines in urinary infections The European Medicines Agency has recommended restricting the use of oral norfloxacin-containing medicines in urinary infections. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the marketing authorisations for oral norfloxacin-containing medicines,Continue Reading

Theraloc (nimotuzumab) for high grade glioma: the manufacturer withdrawed its marketing application

EMEA press release about the marketing authorization withdrawal for the monoclonal antibody nimotuzumab (Theraloc): Oncoscience AG withdraws its application for Theraloc (nimotuzumab) The European Medicines Agency (EMEA) has been formally notified by Oncoscience AG of its decision to withdraw its application for a centralised marketing authorisation for the medicine Theraloc (nimotuzumab), 5 mg/ml concentrate for solution forContinue Reading

EMEA: Physicians should not prescribe Acomplia (rimonabant)

The European Medicines Agency recommends suspension of the marketing authorisation of Acomplia The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Acomplia (rimonabant) from Sanofi-Aventis. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisationContinue Reading

Risk of death in patients with dementia that use typical antipsychotics: EMEA’s press release

Questions and answers on the review of the use of conventional antipsychotic medicines in elderly patients with dementia The European Medicines Agency (EMEA) has completed a review of the evidence available on the safety of conventional antipsychotic medicines in elderly patients with dementia. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that thereContinue Reading

Questions and answers from the EMEA about the withdrawal of Ionysis

Transcription from the EMEA website of the questions and answers document on the recommendation to suspend the marketing authorisation of Ionsys What is Ionsys? Ionsys is a system that delivers the active substance fentanyl hydrochloride into the body through the skin. Fentanyl is an opioid analgesic (a strong painkiller that is related to morphine). Ionsys should only beContinue Reading

Ionsys (fentanyl hydrochloride): EMEA recommends the suspension of its marketing authorisation

Press release about the suspension of Ionsys (fentanyl hydrochloride) marketing authorisation The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation of Ionsys (fentanyl hydrochloride), from Janssen-Cilag International NV, because of a defect with the delivery system of the medicine that could lead to patients being overdosed. Ionsys is a system for the transdermalContinue Reading

Sildenafil still a drug subject to medical prescription

Pfizer withdraws its application to change the marketing authorisation for Viagra 50 mg (sildenafil) from prescription-only to non-prescription The European Medicines Agency (EMEA) has been formally notified by Pfizer Limited of its decision to withdraw its application for a change to the marketing authorisation for the medicine Viagra (sildenafil) 50 mg film-coated tablets. The change concerned switchingContinue Reading

Are you a visual learner interested in learning psychopharmacology? Click here to get our videos