Dear Doctor Letter (Rote-Hand-Brief) on Tredaptive^® (combination of niacin/laropiprant): Discontinuation of marketing

The pharmaceutical manufacturer is sending out information that due to new data available from a clinical trial the marketing of the medicinal product Tredaptive^® has been discontinued and that therefore treatment with this medicinal product is to be terminated. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had previously issued a recommendation of suspension for the marketing authorisations concerned.

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya^® (fingolimod): Recommendations revised in analogy to the recommendations for first use regarding cardiovascular monitoring in case of renewed treatment

Revised recommendations on repeated cardiovascular monitoring in case of renewed treatment with Gilenya^®. These recommendations apply for patients following interruption of treatment and for patients with bradyarrhythmia requiring therapy following initial treatment with Gilenya^®.

Dear Doctor Letter (Rote-Hand-Brief) on Tredaptive^®: Results of a clinical study

Recommendation not to start new patients on treatment with Tredaptive^® as the primary endpoint could not be met in the cardiovascular endpoint study HPS2-THRIVE.

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid^® (lenalidomide): Risk of liver diseases

Information for health care professionals regarding the risk of liver diseases in connection with the use of Revlimid^® (lenalidomide) in the presence of other risk factors.

Update of BfArM eValidator (Software for technical validation of e-submissions)

The BfArM is issuing an updated version of the eValidator (version 5.1 HF1) and kindly requests all users to update the version they are currently using accordingly.

Information on reporting obligations in connection with suspected adverse drug reactions

Due to inquiries about several selected aspects of the reporting obligations in connection with suspected adverse drug reactions regarding the new EU legislation and its implementation in Germany and following the coming into force of the 2nd Act Amending the German Medicinal Products Act, BfArM and PEI are issuing the following information.

Dear Doctor Letter (Rote-Hand-Brief) on Partusisten^® intrapartal (fenoterol hydrobromide): Shortage, possible alternative: Partusisten^® concentrate for solution for infusion

Due to a shortage in the supply of Partusisten^® intrapartal the company has published information that the medicinal product Partusisten^® concentrate for solution for infusion can be used as an alternative. Partusisten^® concentrate for solution for infusion contains the same active substance but in a concentration that is twice as high (50 micrograms/ml instead of 25 micrograms/ml). All other ingredients of the two medicinal products are identical.

Tolperisone: Restriction of indication

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.

Pegasys® pre-filled syringes (pegylated interferon alfa-2a): Risk of possible shortages

A further information letter states that the risk of possible shortages of Pegasys^® pre-filled syringes will persist over longer period of time than originally expected. The company Roche now estimates that the supply situation of the pre-filled syringes will be normalised by the end of June 2013 and not, as communicated up to now, by September of 2012.

eSubmission

BfArM intends to widen the scope for eOnly submissions by also accepting post authorisation applications for medicinal products authorised prior to 31 March 2010.