Messages in brief
Recall "Melphalan Koanaa 50 mg i.v. Powder and solvent for solution for injection or solution for infusion" (active ingredient melphalan)
The medicinal product "Melphalan Koanaa 50 mg i.v. powder and solvent for the preparation of a solution for injection or infusion" (active substance…
Important safety information for refillable insulin pens NovoPen Echo or NovoPen 5 - Replacing the cartridge holder
NovoPen Echo and NovoPen 5 are used for insulin therapy in people with diabetes. It has been noted that the insulin cartridge holder may tear or break…
Symbioflor E. coli - drops recommended only for irritable bowel syndrome and for adults
Measures at EU level
A Europe-wide review of Symbioflor E. coli drops by the European Medicines Agency (EMA) has shown that the drops can continue…
Adverse event reporting - reporting morale slightly increased
The spontaneous reporting system for adverse drug reactions is of enormous importance for the early identification of new risks of medicinal products.…
EudraVigilance New
After the European database EudraVigilance now fulfills all functionalities required by Regulation (EC) No. 726/2004, these have been positively…
Austrian guideline for the designation of medicinal specialties
The new guide summarizes rules and recommendations related to designations and names of human and veterinary drug specialties and is intended to…
Drug Safety Information Platform
Extended recall of EpiPen 300 micrograms and EpiPen Junior 150 micrograms solution for injection in a prefilled pen (epinephrine)
EpiPen 300 microgram solution for injection in a ready-to-use pen (epinephrine) and EpiPen Junior 150 microgram solution for injection in a…
Austrian Medicines Agency is a member of ICMRA
The International Coalition of Medicines Regulatory Agencies (ICMRA) admitted the Federal Office for Healthcare Safety/AGES Medical Market…
Recall of "EpiPen 300 micrograms solution for injection in a ready-to-use pen".
EpiPen 300 micrograms solution for injection in a ready-to-use pen (epinephrine) has been approved under the MRP/DCP procedure since March 30, 1998…
