25.10.2012
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Tolperisone: Restriction of indication
Active substance: tolperisone
Due to the insufficiently demonstrated efficacy in some indications from the range of painful muscular tension and in view of the risk of allergic reactions, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends a restriction of the indications to post-stroke spasticity in adults.
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05.09.2012
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Duogynon: Analysis of a retrospective case series does not show a causal association with birth defects, but it can also not be ruled out with certainty
Active substance:
The analytical results of a retrospective series of case-control studies yielding information on several types of birth defects in newborn babies in connection with the use of Duogynon during early pregnancy are now available to the BfArM.
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30.08.2012
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Codeine: Genetic polymorphism - paediatric deaths
Active substance: codein
Recently, the U.S. licencing authority FDA reported three cases of death and one case of life-threatening respiratory depression following administration of codeine to children between 2 and 5 years of age. According to FDA statements the three children who died were "ultra-rapid" metabolisers, the fourth child was an "extensive" metaboliser.
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11.07.2012
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Carboplatin: Recommendation to filter certain medicinal products containing carboplatin with 0.2 µm filters
Active substance: carboplatin
Further measures have been introduced due to the persisting occurrence of insoluble particles in numerous medicinal products containing carboplatin and because of a possible shortage of medicinal products containing carboplatin.
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04.06.2012
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Carboplatin: Formation of insoluble particles in medicinal products containing carboplatin
Active substance: carboplatin
Further measures have been introduced due to the persisting occurrence of insoluble particles in numerous medicinal products containing carboplatin and because of a possible shortage of medicinal products containing carboplatin.
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16.05.2012
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Carboplatin: Formation of insoluble particles in medicinal products containing carboplatin
Active substance: carboplatin
Extensive measures for risk minimisation have been introduced because of the occurrence of insoluble particles in numerous medicinal products from several pharmaceutical entrepreneurs that contain carboplatin.
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30.03.2012
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Pioglitazone (Actos®, Competact®, Tandemact®): Guide for prescription and risk management
Active substance: pioglitazone
The company Takeda Pharma has published the "Pioglitazone Prescriber's Guide: Patient Selection and Risk Minimisation" thus implementing a further risk minimisation measure from the corresponding decision of the EU Commission.
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09.02.2012
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Ukrain: New findings with regard to detrimental effects of the medicinal product
Active substance:
In the course of recent findings, the BfArM has extended its assessment of the medicinal product Ukrain and now classifies Ukrain as an unsafe medicinal product.
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22.12.2011
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BfArM issues warning against use of Ukrain
Active substance:
According to information available to the BfArM, large amounts of the medicinal product "Ukrain" are still being marketed illegally in Germany and other EU Member States.
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19.12.2011
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Medicinal products containing somatropin: EMA confirms positive benefit/risk balance. Prescribers are reminded to adhere strictly to authorised indications and dosage recommendations
Active substance: somatropin
In the course of the risk assessment procedure for medicinal products containing somatropin, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a recommendation confirming that the benefit/risk balance of these medicinal products remains positive. However, the CHMP does consider it necessary to remind prescribers to adhere strictly to the approved indications and dosage recommendations and to consider warnings and precautions carefully when administering medicines containing somatropin.
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24.11.2011
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GMP shortcomings at Ben Venue Laboratories (BVL), manufacturer of the active substance: Several centrally authorised oncology medicines concerned
Active substance: busulfan, doxorubicin, bortezomib, azacitidine
Due to considerable shortcomings in adhering to Good Manufacturing Practice (GMP) at the Ben Venue Laboratories in the USA, the manufacturer of the active substance, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) assessed and in part recalled the centrally authorised medicinal products Busilvex®, Caelyx®, Velcade® and Vidaza®.
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24.11.2011
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EMA recommends suspension of marketing authorisation for all medicinal products containing buflomedil
Active substance: buflomedil
The Committee for Medicinal Products on Human Use (CHMP) of the European Medicines Agency (EMA) has completed its review of the benefit/risk balance of buflomedil and has come to a negative conclusion. The EMA recommends that all marketing authorisations for medicines containing buflomedil should be suspended throughout the Member States of the EU.
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28.07.2011
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Champix®: The European Medicines Agency confirms a positive benefit-risk balance
Active substance: varenicline
The benefits of Champix® as a smoking-cessation medicine outweigh the reported slight increase in cardiovascular events. The European Medicines Agency has confirmed that the benefit-risk balance for Champix® (varenicline) remains positive, despite the results of a recent meta-analysis on cardiovascular side effects of the medicinal product.
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22.07.2011
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Pioglitazone: The European Medicines Agency recommends new contraindications and warnings for medicinal products containing pioglitazone due to a slightly increased risk of bladder cancer
Active substance: pioglitazone
In its July meeting, the Committee for Medicinal Products for Human Use of the European Medicines Agency finalised the benefit-risk assessment for medicinal products containing pioglitazone. This confirms a slightly increased occurrence of bladder cancer due to pioglitazone. As a risk-minimising measure it recommends that physicians should only administer pioglitazone to patients if it is proven that they will benefit from this therapy. This decision should consider the risk profile of the patients in terms of the occurrence of bladder cancer.
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22.07.2011
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Dronedarone: EMA renews information on the benefit-risk assessment of Multaq®
Active substance: dronedarone
The European Medicines Agency is currently reviewing the benefit-risk balance of the antiarrhythmic agent dronedarone (Multaq®). New study data (PALLAS study) indicate a significantly increased risk of cardiovascular adverse events in patients with permanent atrial fibrillation due to treatment with dronedarone. In January 2011 the CHMP already initiated a procedure to review the benefit-risk balance following reports of severe liver injury including hepatic failure due to dronedarone.
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