Human medicines
Sprycel 100 mg Filmtabletten
Valsartan / Sartan-containing drugs: Pharmaceutical companies to review manufacturing processes to avoid occurrence of nitrosamine-containing impurities
Hepa-Merz 5 g / 10 ml infusion solution concentrate
The marketing authorization holder has informed its supplied customers in a letter dated December 27, 2018, that the above-mentioned batch…
Falsification suspicion of parallel-imported "ALIMTA 500 mg powder for the preparation of a concentrate for infusion solution".
Vitamin C - Injection guide
The marketing authorization holder informed its supplied customers in a letter dated December 18, 2018, that follow-up inspections of the finished…
Prednifluid
The marketing authorization holder informed its supplied customers in a letter dated December 3, 2018, that there are increased reports of side…
Valsartan/HCT from Teva B.V.
The marketing authorization holder informed its supplied customers in a letter dated November 23, 2018, that the active ingredient manufacturer Mylan…
Production-related contamination with N-nitrosodiethylamine (NDEA) in the active ingredient valsartan from the manufacturer "Mylan Laboratory Limited".
Novalgin
The marketing authorization holder has informed its supplied customers in a letter dated November 16, 2018, that isolated impurities or contamination…
Rapibloc
The marketing authorization holder has informed its supplied customers by letter dated Nov. 12, 2018, that due to a slightly increased exceedance of…
