Active ingredients | | Date of last message | Type of reason | AM designation |
Tinzaparin sodium | Initial report | 26.09.2025 | Production problem | innohep 4,500 Anti-Xa I.E. Solution for injection |
Paliperidone palmitate | Change notification | 26.09.2025 | Other | XEPLION 25 mg prolonged-release suspension for injection – OP1ml |
Quetiapine fumarate (Ph.Eur.) | Change notification | 26.09.2025 | Other | Seroquel Prolong 400 mg prolonged-release tablets |
Atorvastatin calcium trihydrate (Ph.Eur.) | Change notification | 25.09.2025 | Other | Atorvastatin Micro Labs 80 mg film-coated tablets |
Atorvastatin calcium trihydrate (Ph.Eur.) | Change notification | 25.09.2025 | Other | Atorvastatin Micro Labs 40 mg film-coated tablets |
Aprepitant | Initial report | 25.09.2025 | Other | Aprepitant AL 125 mg and 80 mg hard capsules |
Isosorbide mononitrate | Change notification | 25.09.2025 | Other | ISMN AL40 retard |
Isosorbide mononitrate | Change notification | 25.09.2025 | Other | ISMN AL 100 retard |
Quetiapine fumarate (Ph.Eur.) | Change notification | 25.09.2025 | Other | Quetiapine AL 200 mg prolonged-release tablets |
Quetiapine fumarate (Ph.Eur.) | Change notification | 25.09.2025 | Other | Quetiapine AL 300 mg film-coated tablets |
Quetiapine fumarate (Ph.Eur.) | Change notification | 25.09.2025 | Other | Quetiapine AL 300 mg prolonged-release tablets |
Phenylephrine hydrochloride | Change notification | 25.09.2025 | Production problem | Neosynephrine-POS 5% |
Aprepitant | Change notification | 25.09.2025 | Other | Aprepitant AL 80 mg hard capsules |
Aprepitant | Change notification | 25.09.2025 | Other | Aprepitant AL 125 mg hard capsules |
Epirubicin hydrochloride | Change notification | 25.09.2025 | Production problem | Epirubicin Hikma 2 mg/ml concentrate for solution for infusion |
Rivastigmine hydrogen tartrate | Change notification | 25.09.2025 | Production problem | Rivastigmine Aurobindo 6 mg hard capsules |
Liraglutide | Change notification | 25.09.2025 | Other | Saxenda 6 mg/ml solution for injection in pre-filled pen – OP(5x3ml) |
Liraglutide | Change notification | 25.09.2025 | Other | Saxenda 6 mg/ml solution for injection in pre-filled pen – OP(3x3ml) |
Insulin aspart | Initial report | 24.09.2025 | Production problem | Fiasp |
Semaglutide | Initial report | 24.09.2025 | Production problem | Ozempic 0.5 mg solution for injection in a pre-filled pen – OP1.5 ml |
Progesterone | Initial report | 24.09.2025 | Production problem | LUTINUS 100 mg vaginal tablets |
Sodium perchlorate 1 H<2>O | Change notification | 24.09.2025 | Other | Irenat drops |
Rifampicin sodium | Change notification | 24.09.2025 | Production problem | Eremfat i.v. 300mg |
Methylphenidate hydrochloride | Change notification | 24.09.2025 | Other | Methylphenidate AL 27 mg prolonged-release tablets |
Azithromycin dihydrate | Change notification | 24.09.2025 | Other | Azithromycin AL 250 mg film-coated tablets |
Quetiapine fumarate (Ph.Eur.) | Change notification | 24.09.2025 | Other | Seroquel Prolong 150 mg prolonged-release tablets |
Clomipramine hydrochloride | Change notification | 23.09.2025 | Production problem | Anafranil 75mg prolonged-release |
Vibegron | Initial report | 23.09.2025 | Production problem | Obgemsa |
Atorvastatin calcium trihydrate (Ph.Eur.) | Change notification | 23.09.2025 | Other | Atorvastatin Micro Labs 60 mg film-coated tablets |
Sevelamer | Change notification | 23.09.2025 | Other | Renagel 800 mg film-coated tablets – OP(1×180) |
Trimipramine mesylate | Change notification | 23.09.2025 | Other | Trimipramine – 1 A Pharma 40 mg/ml oral drops, solution |
Oxcarbazepine | Change notification | 23.09.2025 | Other | Oxcarbazepine – 1 A Pharma 60 mg/ml oral suspension |
Atomoxetine hydrochloride | Change notification | 23.09.2025 | Other | Atomoxe – 1 A Pharma 80 mg hard capsules |
Atomoxetine hydrochloride | Change notification | 23.09.2025 | Other | Atomoxe – 1 A Pharma 60 mg hard capsules |
Atomoxetine hydrochloride | Change notification | 23.09.2025 | Other | Atomoxe – 1 A Pharma 40 mg hard capsules |
Atomoxetine hydrochloride | Change notification | 23.09.2025 | Other | Atomoxe – 1 A Pharma 25 mg hard capsules |
Atomoxetine hydrochloride | Change notification | 23.09.2025 | Other | Atomoxe – 1 A Pharma 18 mg hard capsules |
Atomoxetine hydrochloride | Change notification | 23.09.2025 | Other | Atomoxe – 1 A Pharma 100 mg hard capsules |
Atomoxetine hydrochloride | Change notification | 23.09.2025 | Other | Atomoxe – 1 A Pharma 10 mg hard capsules |
Fosfomycin sodium (Ph.Eur.) | Change notification | 23.09.2025 | Production problem | Fosfomycin Eberth 4 g powder for solution for infusion |
Fosfomycin sodium (Ph.Eur.) | Change notification | 23.09.2025 | Production problem | Fosfomycin Eberth 2 g powder for solution for infusion |
Hydrocortisone | Initial report | 22.09.2025 | Production problem | Alkindi 5 mg granules for removal from capsule – OP50 |
Domperidone | Change notification | 22.09.2025 | Production problem | Motilium drops 10 mg/ml suspension |
Naloxone hydrochloride dihydrate; oxycodone hydrochloride (Ph.Eur.) | Change notification | 22.09.2025 | Production problem | Oxycodone/naloxone Krugmann 20 mg/10 mg prolonged-release tablets |
Naloxone hydrochloride dihydrate; oxycodone hydrochloride (Ph.Eur.) | Change notification | 22.09.2025 | Production problem | Oxycodone / Naloxone Krugmann 40 mg/20 mg prolonged-release tablets |
Oxycodone hydrochloride | Change notification | 22.09.2025 | Other | OXYGESIC 10 mg |
Hydromorphone hydrochloride | Change notification | 22.09.2025 | Production problem | Palladon inject 20 mg/ml solution for injection/infusion |
Calcium chloride dihydrate; histidine; histidine hydrochloride monohydrate; potassium hydrogen 2-oxopentanedioate; potassium chloride; magnesium chloride hexahydrate; mannitol (Ph.Eur.); sodium chloride; tryptophan | Change notification | 22.09.2025 | Production problem | Custodiol |
Beclomethasone dipropionate (Ph.Eur.) | Change notification | 22.09.2025 | Other | Beclorhinol aquosum 50 micrograms |
Imiquimod | Initial report | 22.09.2025 | Production problem | Imikeraderm 50 mg/g cream |
Trandolapril; verapamil hydrochloride | Initial report | 22.09.2025 | Other | Tarka 240 mg/4 mg modified-release tablets |