Active ingredients | Report type | Date of last message | Type of reason | AM designation |
Duloxetine hydrochloride | Change notification | 25.07.2025 | Production problem | Duloxetine PUREN 60 mg gastro-resistant hard capsules |
Chorionic gonadotropin | Initial report | 25.07.2025 | Other | BREVACTID 1500 I.E. Powder and solvent for solution for injection |
Human insulin (with manufacturing details) | Initial report | 25.07.2025 | Other | Berlinsulin H Normal 3 ml pen |
Betamethasone valerate (Ph.Eur.) | Initial report | 25.07.2025 | Other | Soderm crinale |
Azacitidine | Initial report | 25.07.2025 | Other | Azacitidine HEXAL 25 mg/ml powder for suspension for injection |
Minocycline hydrochloride dihydrate (Ph.Eur.) | Initial report | 25.07.2025 | Production problem | Skid 100 mg |
Minocycline hydrochloride dihydrate (Ph.Eur.) | Initial report | 25.07.2025 | Production problem | Skid 50 mg |
Galantamine hydrobromide | Initial report | 24.07.2025 | Other | Galanaxiro 24 mg hard capsules, delayed release |
Galantamine hydrobromide | Initial report | 24.07.2025 | Other | Galanaxiro 16 mg Hard capsules, delayed release |
Galantamine hydrobromide | Initial report | 24.07.2025 | Other | Galanaxiro 8 mg hard capsules, delayed release |
Lorazepam | Change notification | 24.07.2025 | Other | Tavor 1.0 mg Expidet |
Carbamazepine | Change notification | 24.07.2025 | Other | Carbamazepine AL 400 delayed release |
Methylphenidate hydrochloride | Change notification | 24.07.2025 | Other | Methylphenidate AL 18 mg prolonged-release tablets |
Tacrolimus monohydrate | Change notification | 24.07.2025 | Other | Tacrolimus AL 5 mg hard capsules, delayed release |
Tacrolimus monohydrate | Change notification | 24.07.2025 | Other | Tacrolimus AL 1 mg hard capsules, delayed release |
Tacrolimus monohydrate | Change notification | 24.07.2025 | Other | Tacrolimus AL 0.5 mg hard capsules, delayed release |
Tacrolimus monohydrate | Change notification | 24.07.2025 | Other | Tacrolimus AL 3 mg hard capsules, delayed release |
Duloxetine hydrochloride | Change notification | 24.07.2025 | Other | Duloxetine AL 120 mg gastro-resistant hard capsules |
Quetiapine fumarate (Ph.Eur.) | Change notification | 24.07.2025 | Other | Quetiapine AL 100 mg film-coated tablets |
Selegiline hydrochloride | Initial report | 24.07.2025 | Other | Selegiline AL 10 |
Selegiline hydrochloride | Change notification | 24.07.2025 | Other | Selegiline AL 5 |
Ribavirin | Change notification | 24.07.2025 | Other | Ribavirin-ratiopharm 400 mg film-coated tablets |
Insulin aspart | Initial report | 23.07.2025 | Other | NovoRapid 100 E/ml solution for injection in vial – OP[5x(1x10ml)] |
Paliperidone palmitate | Change notification | 23.07.2025 | Other | Paliperidone AL 25 mg depot injection suspension in a pre-filled syringe |
Azithromycin dihydrate | Initial report | 23.07.2025 | Other | Azithromycin AL 250 mg film-coated tablets |
Insulin lispro | Initial report | 22.07.2025 | Other | Liprolog 100 E/ml solution for injection in vial – OP[5x(1x10ml)] |
Trandolapril; verapamil hydrochloride | Change notification | 22.07.2025 | Production problem | Tarka 240 mg/2 mg tablets with modified release |
Zoledronic acid monohydrate | Change notification | 22.07.2025 | Other | Zole – 1 A Pharma 5 mg/100 ml infusion solution |
Trimipramine mesylate | Change notification | 22.07.2025 | Other | Trimipramine – 1 A Pharma 40 mg/ml oral drops, solution |
Pramipexole dihydrochloride monohydrate | Change notification | 22.07.2025 | Other | Pramipexole HEXAL 0.52 mg prolonged-release tablets |
Cyclophosphamide monohydrate | Change notification | 22.07.2025 | Other | Cyclophosphamide HEXAL 2000 mg |
Chlortalidone | Change notification | 22.07.2025 | Other | Chlortalidone HEXAL 50 mg tablets |
Semaglutide | Change notification | 22.07.2025 | Other | Ozempic 1 mg injection solution in a pre-filled pen – OP(3x3ml) |
Chlortalidone | Change notification | 22.07.2025 | Other | Chlortalidone HEXAL 25 mg tablets |
Atomoxetine hydrochloride | Change notification | 22.07.2025 | Other | Atomoxe – 1 A Pharma 80 mg hard capsules |
Atomoxetine hydrochloride | Change notification | 22.07.2025 | Other | Atomoxe – 1 A Pharma 60 mg hard capsules |
Atomoxetine hydrochloride | Change notification | 22.07.2025 | Other | Atomoxe – 1 A Pharma 40 mg hard capsules |
Atomoxetine hydrochloride | Change notification | 22.07.2025 | Other | Atomoxe – 1 A Pharma 25 mg hard capsules |
Atomoxetine hydrochloride | Change notification | 22.07.2025 | Other | Atomoxe – 1 A Pharma 18 mg hard capsules |
Atomoxetine hydrochloride | Change notification | 22.07.2025 | Other | Atomoxe – 1 A Pharma 100 mg hard capsules |
Atomoxetine hydrochloride | Change notification | 22.07.2025 | Other | Atomoxe – 1 A Pharma 10 mg hard capsules |
Urapidil | Initial report | 21.07.2025 | Other | Ebrantil 30 mg |
Lidocaine | Initial report | 21.07.2025 | Production problem | XYLOCAIN PUMP SPRAY |
Salbutamol sulfate | Change notification | 21.07.2025 | Other | Bronchospray novo |
Quetiapine fumarate (Ph.Eur.) | Change notification | 21.07.2025 | Production problem | Quetiapine Heumann retard 150 mg prolonged-release tablets |
Quetiapine fumarate (Ph.Eur.) | Change notification | 21.07.2025 | Production problem | Quetiapine Heumann retard 400 mg prolonged-release tablets |
Quetiapine fumarate (Ph.Eur.) | Change notification | 21.07.2025 | Production problem | Quetiapine Heumann retard 50 mg prolonged-release tablets |
Quetiapine fumarate (Ph.Eur.) | Change notification | 21.07.2025 | Production problem | Quetiapine Heumann retard 200 mg prolonged-release tablets |
Quetiapine fumarate (Ph.Eur.) | Change notification | 21.07.2025 | Production problem | Quetiapine Heumann retard 300 mg prolonged-release tablets |
Flunisolid hemihydrate | Change notification | 21.07.2025 | Other | Syntaris |
Framycetin sulfate (Ph.Eur.) | Change notification | 21.07.2025 | Other | Leukase N ointment |
Fluorouracil | Change notification | 21.07.2025 | Other | Fluorouracil Hikma 50 mg/ml solution for injection |
2025年7月28日