Pharmacovigilance
By the time medicinal products are granted a marketing authorisation, knowledge about their safety is incomplete because the clinical trials investigating the safety profile and efficacy are usually performed with a relatively small number of subjects. Furthermore these subjects are selected with regard to special aspects and in general do not represent the average patient in medical practices. Therefore, rare or very rare adverse drug reactions, interactions or other hazards related to the use of a medicinal product cannot be observed during clinical trials. Especially the rarely occurring serious adverse reactions are very important for the overall assessment of a new medicinal product. New findings regarding the safety of a medicinal product may occur even long time after its authorisation and depend on new developments in medical science.
Therefore, the German Medicines Act (Arzneimittelgesetz, AMG) provides that information obtained during the use of a medicinal product be continuously and systematically collected and evaluated after the marketing authorisation is granted. This is done for all finished products on the market in Germany and is the most important duty of the Pharmacovigilance Division. This Division continuously informs about adverse drug reactions and interactions related to the use of medicinal products which have become known and ensures that patients, medical doctors and other interested parties are made aware of existing risks as well as of possibilities to decrease them. If, due to the risk assessment of a medicinal product, its marketing authorisation status needs to be adopted to the state of scientific knowledge, the Pharmacovigilance Division co-ordinates the measures necessary for risk prevention and informs patients, medical doctors and other interested parties accordingly.
Pharmacovigilance - News
Search results 1 to 20 from a total of 96 (5 pages).
| Date | Title | Link |
|---|---|---|
| 2012.02.02 |
Mircera® (methoxy polyethylene glycol-epoetin beta): Possible shortages: Note on switching to alternative treatments An information letter with treatment recommendations has been circulated to treating physicians and pharmacies concerned. |
to article |
| 2012.01.27 |
Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): Increased cardiovascular monitoring at the beginning of treatment Important additional recommendations regarding a more intense monitoring of cardiovascular functions at the beginning of treatment with Gilenya® (fingolimod) in patients with relapsing-remitting multiple sclerosis. |
to article |
| 2012.01.16 |
Dear Doctor Letter (Rote-Hand-Brief) on Velcade® (bortezomib): Intravenous injection is the only correct route of administration The only licensed route of administration of Velcade® (1 mg, 3.5 mg, powder for solution for injection) is via intravenous injection. Velcade® must not be administered in any other manner. |
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| 2011.12.29 |
Dear Doctor Letter (Rote-Hand-Brief) on UVADEX™: Visual inspection of vials prior to administration Therakos Europe advises healthcare professionals to visually inspect the UVADEX™ vials prior to administration in order to exclude particle contamination. Furthermore, suspected cases of sepsis should be reported along with the numbers of the suspected batch(es). |
to article |
| 2011.12.29 |
Dear Doctor Letter (Rote-Hand-Brief) on Hexvix®: Visual inspection of vials prior to administration Ipsen Pharma GmbH advises healthcare professionals to visually inspect the Hexvix® vials prior to administration in order to exclude particle contamination. Furthermore, suspected cases of sepsis should be reported along with the numbers of the suspected batch(es). |
to article |
| 2011.12.23 |
Dear Doctor Letter (Rote-Hand-Brief) on Virazole® (ribavirin) 6 g dry substance, powder to be reconstituted for aerosol administration: Problems with sterility and particle contamination at the manufacturing site MEDA Pharma recommends only treating patients with Virazole® if its use is considered to be absolutely essential. |
to article |
| 2011.12.22 |
BfArM issues warning against use of Ukrain 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. |
to article |
| 2011.12.19 |
Medicinal products containing somatropin: EMA confirms positive benefit/risk balance. Prescribers are reminded to adhere strictly to authorised indications and dosage recommendations 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. |
to article |
| 2011.12.13 |
Dear Doctor Letter (Rote-Hand-Brief) on Strattera® (atomoxetine): Risk of increased blood pressure and/or heart rate Important safety-relevant information on the risk of increased blood pressure and/or heart rate associated with the use of Strattera® (atomoxetine) for treatment of Attention Deficit/Hyperactivity Disorder (ADHD). |
to article |
| 2011.12.12 |
PSUR Worksharing Project: Assessment of the combination of the active substances Chlormadinone acetate and Ethinylestradiol The combination of the active substances chlormadinone acetate and ethinylestradiol will be assessed as part of the PSUR Worksharing Project of the Heads of Medicines Agencies (HMA). The BfArM has taken the role of the P-RMS. Companies interested in participating in the PSUR Worksharing Project for the a.m. combination of active substances are requested to submit a PSUR. |
to article |
| 2011.12.09 |
Dear Doctor Letter (Rote-Hand-Brief) on Ceplene® (0.5 mg/0.5 ml solution for injection): Contamination of the diluent The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) advises healthcare professionals to visually inspect the vial prior to administration of Ceplene® in order to exclude particle contamination. The background for this recommendation is the discovery of significant shortcomings in the Good Manufacturing Practice (GMP) at Ben Venue Laboratories, the manufacturing site where Ceplene® is produced. |
to article |
| 2011.12.09 |
Dear Doctor Letter (Rote-Hand-Brief) on Torisel® (temsirolimus, concentrate and diluent for solution for infusion): Contamination of the diluent The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) advises healthcare professionals to visually inspect the diluent prior to administration of Torisel® in order to exclude particle contamination. The background for this recommendation is the discovery of significant shortcomings in the Good Manufacturing Practice (GMP) at Ben Venue Laboratories, the manufacturing site where the diluent for Torisel® is produced. |
to article |
| 2011.12.05 |
Dear Doctor Letter (Rote-Hand-Brief) on Cipralex® (escitalopram): Risk of dose-dependent QT interval prolongation and altered recommendations as to the maximum dose in patients older than 65 years Important information on the risk of dose-dependent prolongations of the QT interval as well as on altered recommendations as to the maximum dose in patients over 65 years of age. These new scientific findings also apply to all generic marketing authorisations of escitalopram. For these generics the BfArM has also initiated implementation of corresponding changes. |
to article |
| 2011.11.28 |
Dear Doctor Letter (Rote-Hand-Brief) on Caelyx® (pegylated liposomal doxorubicin): Supply failure, safety aspects Supply failure of Caelyx® (pegylated liposomal doxorubicin) resulting in a further decline in patient supply. |
to article |
| 2011.11.24 |
Information letter regarding Apidra® cartridges (insulin glulisine) for injection: Supply of Apidra® Updated information on the availability of Apidra® 3 ml cartridges and further steps until full availability has been restored. |
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| 2011.11.24 |
GMP shortcomings at Ben Venue Laboratories (BVL), manufacturer of the active substance: Several centrally authorised oncology medicines concerned 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®. |
to article |
| 2011.11.24 |
EMA recommends suspension of marketing authorisation for all medicinal products containing 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. |
to article |
| 2011.11.21 |
Information letter on Velcade® 1 mg powder for solution for injection (bortezomib) : Discontinuation of supply due to production difficulties The pharmaceutical manufacturer issues information on the discontinuation of supply of Velcade® 1 mg powder for solution for injection due to production difficulties on the part of the contract manufacturer. |
to article |
| 2011.11.07 |
PSUR Worksharing Project: Evaluation of Olmesartan A PSUR on olmesartan is up for evaluation in the PSUR Worksharing Project of the Heads of Medicines Agencies (HMA). The BfArM will be the P-RMS. Companies concerned with the above-mentioned substance who wish to take part in the PSUR Worksharing Project, are requested to submit a PSUR. |
to article |
| 2011.11.07 |
PSUR Worksharing Project: Assessment of the combination of the active substances Olmesartan/Hydrochlorothiazid The combination of the active substances olmesartan and hydrochlorothazid will be assessed as part of the PSUR Worksharing Project of the Heads of Medicines Agencies (HMA). The BfArM has taken the role of the P-RMS. Companies interested in participating in the PSUR Worksharing Project for the a.m. combination of active substances are requested to submit a PSUR. |
to article |