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Dear Doctor Letter (Rote-Hand-Brief) on Caelyx® (pegylated liposomal doxorubicin): Shortage, introduction of a web-based ordering and reservation system PDF, 152KB, File is accessible Date: 30. October 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

Supply problems with regard to Caelyx® have been reported in the past. A further letter with information on the reintroduction of Caelyx® is being circulated now. Due to the persisting shortage the company has introduced a web-based ordering …

Rote-Hand-Brief on Caelyx® PDF, 152KB, File is accessible Date: 29. October 2012 Topics: Pharmakovigilanz Type: Download

Active substance: pegylated liposomal doxorubicin

Information Letter on Valdoxan®/Thymanax® PDF, 190KB, File is accessible Date: 25. October 2012 Topics: Pharmakovigilanz Type: Download

Active substance: agomelatine

Tolperisone: Restriction of indication Date: 25. October 2012 Topics: Pharmakovigilanz Type: Risk information

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 …

Agomelatine (Valdoxan®/Thymanax®): Risk of hepatotoxicity PDF, 190KB, File is accessible Date: 25. October 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: agomelatine

Liver function tests are to be performed regularly in patients treated with agomelatine. The medicinal product should be discontinued immediately if an increase in transaminases exceeds 3 times the upper limit of normal or if typical symptoms …

Information Letter on Pegasys® PDF, 2MB, File is accessible Date: 04. October 2012 Topics: Pharmakovigilanz Type: Download

Active substance: pegylated interferon alfa 2a

Pegasys® pre-filled syringes (pegylated interferon alfa-2a): Risk of possible shortages PDF, 2MB, File is accessible Date: 04. October 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated interferon alfa-2a

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 …

Macugen® (pegaptanib sodium): Risk of a serious increase in intraocular pressure due to intravitreal injection of excess volume of Macugen® PDF, 157KB, File is accessible Date: 01. October 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegaptanib sodium

In order to ensure a safe intravitreal administration of Macugen®, the excess volume must be expelled from the pre-filled syringe before use.

Information Letter on Macugen® PDF, 157KB, File is accessible Date: 28. September 2012 Topics: Pharmakovigilanz Type: Download

active substance: pegaptanib sodium

Information Letter on Carmubris® PDF, 239KB, File is accessible Date: 14. September 2012 Topics: Pharmakovigilanz Type: Download

Active substance: carmustine

Information Letter on Carmubris® powder and solution for infusion (carmustine, 100 mg): Overfilled vial found PDF, 239KB, File is accessible Date: 14. September 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carmustine

In the course of routine stability testing, an overfilled vial was found in a specific batch of Carmubris®. Such overfilled vials pose a significant risk of overdosing patients.

Information Letter on Neupro®/Leganto® (rotigotine transdermal patch): New room-temperature stable formulation PDF, 203KB, File is accessible Date: 10. September 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rotigotine

Licensing of improved formulation for Neupro®/Leganto® allowing storage at room temperature.

Information Letter on Neupro®/Leganto® PDF, 203KB, File is accessible Date: 10. September 2012 Topics: Pharmakovigilanz Type: Download

Active substance: rotigotine

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 Date: 05. September 2012 Topics: Pharmakovigilanz Type: Risk information

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.

Dear Doctor Letter (Rote-Hand-Brief) on Zostex® (brivudine): Potentially fatal interaction with 5-fluoropyrimidines PDF, 577KB, File is accessible Date: 03. September 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: brivudine

Important information to be observed: concomitant use of brivudine and 5-fluoropyrimidines (also in topical preparations and in combination medicinal products) is contraindicated due to the risk of potentially fatal interactions.

Dear Doctor Letter (Rote-Hand-Brief) on Tavanic® (levofloxacin) and generic medicinal products: Restriction of indications, new serious adverse reactions and precautions for use PDF, 601KB, File is accessible Date: 03. September 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levofloxacin

In agreement with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), restrictions of indications and the inclusion of new serious adverse reactions as well as corresponding warnings in the product …

Rote-Hand-Brief on Zostex® PDF, 577KB, File is accessible Date: 31. August 2012 Topics: Pharmakovigilanz Type: Download

Active substance: brivudine

Rote-Hand-Brief on Tavanic® PDF, 601KB, File is accessible Date: 31. August 2012 Topics: Pharmakovigilanz Type: Download

Active substance:: levofloxacin

Additional information (available in German only):

Codeine: Genetic polymorphism - paediatric deaths Date: 30. August 2012 Topics: Pharmakovigilanz Type: Risk information

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 …

Dear Doctor Letter (Rote-Hand-Brief) on DepoCyte® 50 mg suspension for injection (liposomal cytarabine for intrathecal injection): Recall of the medicinal product PDF, 224KB, File is accessible Date: 29. August 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: liposomal cytarabine

During an inspection, critical deficiencies were found at the manufacturing site of the finished product DepoCyte®. Due to the potential risk of lacking sterility the medicinal product is recalled. Patients are to be switched to alternative …

Rote-Hand-Brief on calcitonin-containing medicinal products PDF, 53KB, File is accessible Date: 15. August 2012 Topics: Pharmakovigilanz Type: Download

Active substance: calcitonin

Dear Doctor Letter (Rote-Hand-Brief) on calcitonin: Restriction of indication PDF, 53KB, File is accessible Date: 15. August 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: calcitonin

Important information on the connection between calcitonin and malignancies – new restrictions for use and recall of nasal spray.

Information letter on ZOFRAN® (ondansetron) and generic medicinal products PDF, 889KB, File is accessible Date: 14. August 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ondansetron

The pharmaceutical manufacturer issues information on important new findings regarding ondansetron (ZOFRAN® and generics) and the dose-dependent QTc interval prolongation – new reduction of intravenous dose.

Information Letter on Zofran® und Generika PDF, 889KB, File is accessible Date: 14. August 2012 Topics: Pharmakovigilanz Type: Download

Active substance: ondansetron

Information Letter on Torisel® PDF, 2MB, File is accessible Date: 19. July 2012 Topics: Pharmakovigilanz Type: Download

Active substance:: temsirolimus

Information Letter on Torisel® (temsirolimus): Fragments of glass possibly present in the diluent PDF, 2MB, File is accessible Date: 19. July 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: temsirolimus

Important information on the possible presence of fragments of glass in batches AGBV/99 and AGQQ/13 of vials of the diluent Torisel® and recommended measures.

Carboplatin: Recommendation to filter certain medicinal products containing carboplatin with 0.2 µm filters Date: 11. July 2012 Topics: Pharmakovigilanz Type: Risk information

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.

Dear Doctor Letter (Rote-Hand-Brief) on Doribax® (doripenem): New therapeutic recommendations PDF, 138KB, File is accessible Date: 11. July 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: doripenem

New recommendations regarding dosage and duration of treatment as well as precautionary measures when administering Doribax® (doripenem) to patients with nosocomial pneumonia.

Rote-Hand-Brief on Doribax® PDF, 138KB, File is accessible Date: 10. July 2012 Topics: Pharmakovigilanz Type: Download

Active substance: doripenem

Dear Doctor Letter (Rote-Hand-Brief) on VOLIBRIS® (ambrisentan): New Contraindication PDF, 1MB, File is accessible Date: 09. July 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ambrisentan

VOLIBRIS® (ambrisentan) must not be given to patients with idiopathic pulmonary fibrosis (IPF).