PARTICIPATION of BfArM at the COMMON EU SUBMISSION PLATFORM (CESP) PROJECT

BfArM joins the ‘extended Proof of Concept’ for the CESP Project aiming to establish a single portal for electronic submissions to multiple competent authorities in the context of European registration and post-approval procedures in the EEA.

BfArM’s updated assessment concerning oxygen concentrators

Survey on the updated recommendation addressed to the local competent authorities concerning oxygen concentrators

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.

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).

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.

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.

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.

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.

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.

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.