Active ingredients | | Date of last message | Type of reason | AM designation |
Sertraline hydrochloride | Change notification | 15.08.2025 | Other | Sertraline TAD 100 mg film-coated tablets |
Sertraline hydrochloride | Change notification | 15.08.2025 | Other | Sertraline TAD 50 mg film-coated tablets |
Phenoxybenzamine hydrochloride | Change notification | 15.08.2025 | Other | Dibenzyran 10 |
Atorvastatin calcium trihydrate (Ph.Eur.) | Change notification | 15.08.2025 | Other | Atorvastatin Micro Labs 20 mg film-coated tablets |
Atorvastatin calcium trihydrate (Ph.Eur.) | Change notification | 15.08.2025 | Other | Atorvastatin Micro Labs 40 mg film-coated tablets |
Atorvastatin calcium trihydrate (Ph.Eur.) | Change notification | 15.08.2025 | Other | Atorvastatin Micro Labs 80 mg film-coated tablets |
Rifampicin | Change notification | 15.08.2025 | Production problem | EREMFAT 450 mg |
Acetylcholine chloride | Change notification | 15.08.2025 | Production problem | Miochol-E powder and solvent for the preparation of an instillation solution for intraocular use |
Azithromycin dihydrate | Change notification | 15.08.2025 | Other | Azithromycin AL 250 mg film-coated tablets |
Galantamine hydrobromide | Change notification | 14.08.2025 | Production problem | Galantamine Heumann 24 mg hard capsules, delayed release |
Quetiapine fumarate (Ph.Eur.) | Change notification | 14.08.2025 | Production problem | Quetiapine Heumann retard 200 mg prolonged-release tablets |
Quetiapine fumarate (Ph.Eur.) | Change notification | 14.08.2025 | Production problem | Quetiapine Heumann retard 150 mg prolonged-release tablets |
Quetiapine fumarate (Ph.Eur.) | Change notification | 14.08.2025 | Production problem | Quetiapine Heumann retard 50 mg prolonged-release tablets |
Sodium diphosphate decahydrate for the manufacture of radioactive medicinal products | Initial | 14.08.2025 | Other | Technescan PYP |
Tobramycin | Change notification | 14.08.2025 | Production problem | TOBI Podhaler 28 mg hard capsules with powder for inhalation – OP224(4×56) |
Alprazolam | Initial | 14.08.2025 | Other | Alprazolam-ratiopharm 1.0 mg tablets |
Emtricitabine; tenofovir disoproxil maleate | Change notification | 14.08.2025 | Other | Emtricitabine/tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets – OP30(Fl) |
Naloxegol oxalate | Initial | 13.08.2025 | Other | Moventig 25 mg film-coated tablets – OP100(100×1) |
Isoniazid | Change notification | 13.08.2025 | Other | Isozid 200 mg |
Methyl (5-amino-4-oxopentanoate) hydrochloride | Change notification | 12.08.2025 | Other | Metvix 160 mg/g cream |
Olanzapine | Initial | 12.08.2025 | Production problem | Olanzapine Glenmark 5 mg tablets – OP70 |
Olanzapine | Initial | 12.08.2025 | Production problem | Olanzapine Glenmark 2.5 mg tablets – OP70 |
Olanzapine | Initial | 12.08.2025 | Production problem | Olanzapine Glenmark 2.5 mg tablets – OP56 |
Olanzapine | Initial | 12.08.2025 | Production problem | Olanzapine Glenmark 10 mg tablets – OP70 |
Olanzapine | Initial | 12.08.2025 | Production problem | Olanzapine Glenmark 10 mg tablets – OP56 |
Trazodone hydrochloride | Change notification | 12.08.2025 | Production problem | Trazodone Glenmark 100 mg tablets |
Rizatriptan benzoate | Change notification | 12.08.2025 | Production problem | Rizatriptan Glenmark 10 mg tablets |
Rizatriptan benzoate | Change notification | 12.08.2025 | Production problem | Rizatriptan Glenmark 10 mg orodispersible tablets |
Rizatriptan benzoate | Change notification | 12.08.2025 | Production problem | Rizatriptan Glenmark 5 mg orodispersible tablets |
Rizatriptan benzoate | Change notification | 12.08.2025 | Production problem | Rizatriptan Glenmark 5 mg tablets |
Quetiapine fumarate (Ph.Eur.) | Initial | 12.08.2025 | Production problem | Quetiapine Glenmark 300 mg prolonged-release tablets |
Quetiapine fumarate (Ph.Eur.) | Change notification | 12.08.2025 | Production problem | Quetiapine Glenmark 400 mg prolonged-release tablets |
Quetiapine fumarate (Ph.Eur.) | Change notification | 12.08.2025 | Production problem | Quetiapine Glenmark 200 mg prolonged-release tablets |
Quetiapine fumarate (Ph.Eur.) | Change notification | 12.08.2025 | Production problem | Quetiapine Glenmark 150 mg prolonged-release tablets |
Mometasone furoate (Ph.Eur.) | Change notification | 12.08.2025 | Production problem | Mometasone Glenmark 1 mg/g ointment |
Linezolid | Change notification | 12.08.2025 | Production problem | Linezolid Glenmark 600 mg film-coated tablets |
Galantamine hydrobromide | Change notification | 12.08.2025 | Production problem | Galantamine Glenmark 24 mg hard capsules, delayed release |
Galantamine hydrobromide | Change notification | 12.08.2025 | Production problem | Galantamine Glenmark 8 mg hard capsules, delayed release |
Galantamine hydrobromide | Change notification | 12.08.2025 | Production problem | Galantamine Glenmark 16 mg hard capsules, delayed release |
Pirfenidone | Initial | 12.08.2025 | Production problem | Pirfenidone Accord 801 mg film-coated tablets |
Ezetimibe; Simvastatin | Initial | 12.08.2025 | Production problem | Ezetimibe/Simvastatin Glenmark 10 mg/20 mg tablets |
Alprazolam | Initial | 12.08.2025 | Other | Alprazolam – 1 A Pharma 1 mg tablets |
Alprazolam | Initial | 12.08.2025 | Other | Alprazolam – 1 A Pharma 0.5 mg tablets |
Gabapentin | Initial | 12.08.2025 | Production problem | Gabapentin Holsten 800 mg film-coated tablets |
Gabapentin | Initial | 12.08.2025 | Other | Gabapentin Holsten 100 mg hard capsules |
Doxepine hydrochloride (Ph.Eur.) | Initial | 12.08.2025 | Other | Doxepin 75 Holsten |
Zoledronic acid monohydrate | Change notification | 12.08.2025 | Production problem | Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion – OP5ml |
Rifampicin | Initial | 12.08.2025 | Other | EREMFAT 300 mg |
Vancomycin hydrochloride | Initial | 12.08.2025 | Other | Vancomycin “Lederle” 1000 mg |
Urapidil | Change notification | 12.08.2025 | Other | Urapidil PUREN 90 mg prolonged-release capsules |
Topiramate | Change notification | 12.08.2025 | Production problem | Topiramate PUREN 100 mg film-coated tablets |
Sitagliptin hydrochloride monohydrate | Change notification | 12.08.2025 | Production problem | Sitagliptin PUREN 50 mg film-coated tablets |
Sitagliptin hydrochloride monohydrate | Change notification | 12.08.2025 | Production problem | Sitagliptin Aurobindo 25 mg film-coated tablets |
Rizatriptan benzoate | Change notification | 12.08.2025 | Production problem | Rizatriptan PUREN 5 mg tablets |
Rizatriptan benzoate | Change notification | 12.08.2025 | Other | Rizatriptan PUREN 10 mg tablets |
Rizatriptan benzoate | Change notification | 12.08.2025 | Other | Rizatriptan Aurobindo 10 mg orodispersible tablets |
Risperidone | Change notification | 12.08.2025 | Other | Risperidone PUREN 1 mg film-coated tablets |
Risperidone | Change notification | 12.08.2025 | Other | Risperidone Aurobindo 1 mg film-coated tablets |
Docetaxel | Change notification | 12.08.2025 | Other | Docetaxel Aurobindo 20 mg/ml concentrate for solution for infusion |
Nevirapine | Change notification | 12.08.2025 | Other | Nevirapine Aurobindo 400 mg prolonged-release tablets |
Moxifloxacin hydrochloride (Ph.Eur.) (with information on water content (1:x)) | Change notification | 12.08.2025 | Production problem | Moxifloxacin Aurobindo 400 mg film-coated tablets |
Moxifloxacin hydrochloride (Ph.Eur.) (with information on water content (1:x)) | Change notification | 12.08.2025 | Production problem | Moxifloxacin PUREN 400 mg film-coated tablets |
Ibuprofen | Change notification | 12.08.2025 | Other | IBU-PUREN acute 400 mg film-coated tablets |
Oxycodone hydrochloride (Ph.Eur.) | Change notification | 11.08.2025 | Other | Oxygesic 5 mg |
Paliperidone palmitate | Change notification | 11.08.2025 | Production problem | Paliperidone Advanz Pharma 25 mg Depot injection suspension in a pre-filled syringe |
Paliperidone palmitate | Change notification | 11.08.2025 | Production problem | Paliperidone Advanz Pharma 50 mg depot injection suspension in a pre-filled syringe |
Hydromorphone hydrochloride | Change notification | 11.08.2025 | Other | Hydromorphone HEXAL 2.6 mg hard capsules |
Insulin aspart | Initial | 11.08.2025 | Other | NovoRapid PumpCart 100 E/ml injection solution in cartridge – OP[5x(5×1.6ml)] |
Chlortalidone | Change notification | 11.08.2025 | Other | Chlortalidone HEXAL 25 mg tablets |
Chlortalidone | Change notification | 11.08.2025 | Other | Chlortalidone HEXAL 50 mg tablets |
Sufentanil | Initial | 11.08.2025 | Production problem | Sufentanil-hameln 50 micrograms/ml injection/infusion solution |
Oxycodone hydrochloride (Ph.Eur.) | Initial | 11.08.2025 | Other | Oxycodone-HCl HEXAL 40 mg prolonged-release tablets |
Oxycodone hydrochloride (Ph.Eur.) | Initial | 11.08.2025 | Other | Oxycodone-HCl HEXAL 20 mg prolonged-release tablets |
Oxycodone hydrochloride (Ph.Eur.) | Initial | 11.08.2025 | Other | Oxycodone-HCl HEXAL 10 mg prolonged-release tablets |
Oxycodone hydrochloride (Ph.Eur.) | Initial | 11.08.2025 | Other | Oxycodone-HCl HEXAL 5 mg prolonged-release tablets |
Hydromorphone hydrochloride | Change notification | 11.08.2025 | Other | Hydromorphone HCl PUREN 4 mg hard capsules, delayed release |
Escitalopram oxalate | Change notification | 11.08.2025 | Other | Escitalopram Aurobindo 10 mg film-coated tablets |
Etoricoxib | Change notification | 11.08.2025 | Other | Etoricoxib PUREN 120 mg film-coated tablets |
Atorvastatin calcium trihydrate (Ph.Eur.) | Change notification | 11.08.2025 | Other | Atorvastatin PUREN 40 mg film-coated tablets |
Gabapentin | Change notification | 11.08.2025 | Other | Gabapentin Aurobindo 400 mg hard capsules |
Prasugrel | Change notification | 11.08.2025 | Production problem | Prasugrel PUREN 5 mg film-coated tablets |
Lamotrigine | Change notification | 11.08.2025 | Production problem | Lamotrigine Aurobindo 50 mg tablets |
Ramipril | Change notification | 11.08.2025 | Other | Ramipril PUREN 5 mg tablets |
Pregabalin | Change notification | 11.08.2025 | Other | Pregabalin Aurobindo 25 mg hard capsules |
Pregabalin | Change notification | 11.08.2025 | Other | Pregabalin PUREN 100 mg hard capsules |