Active ingredients | | Date of last message | Type of reason | AM designation |
Midodrine hydrochloride | Change notification | 22.08.2025 | Other | Gutron tablets |
Beclometasone dipropionate (Ph.Eur.) | Initial | 21.08.2025 | Other | Beclorhinol aquosum 50 micrograms |
Calcium acetate hydrate ((with information on water content (1:x))) | Change notification | 21.08.2025 | Production problem | Renacet 950 mg |
Gabapentin | Initial | 21.08.2025 | Other | Gabapentin Holsten 300 mg hard capsules |
Gabapentin | Initial | 21.08.2025 | Production problem | Gabapentin Holsten 600 mg film-coated tablets |
Carbamazepine | Change notification | 21.08.2025 | Other | Carbadura 400 mg retard |
Insulin aspart | Change notification | 21.08.2025 | Other | NovoRapid PumpCart 100 E/ml solution for injection in cartridge – OP[5x(5×1.6ml)] |
Methylphenidate hydrochloride | Initial | 21.08.2025 | Other | Methylphenidate hydrochloride – Neuraxpharm 18 mg prolonged-release tablets |
Human insulin (with manufacturing details); isophane insulin suspension for injection (Ph.Eur.) | Change notification | 21.08.2025 | Other | Actraphane 30 FlexPen 100 IU/ml injection suspension in injector – OP(10x3ml) |
Biperiden hydrochloride | Change notification | 21.08.2025 | Production problem | Biperiden-neuraxpharm 4 mg |
Biperiden hydrochloride | Change notification | 21.08.2025 | Production problem | Biperiden-neuraxpharm 2 mg |
Trimipramine mesylate | Change notification | 20.08.2025 | Other | Trimipramine – 1 A Pharma 40 mg/ml oral drops, solution |
Hydromorphone hydrochloride | Change notification | 20.08.2025 | Other | Hydromorphone-HEXAL 2.6 mg hard capsules |
Zoledronic acid monohydrate | Change notification | 20.08.2025 | Production problem | Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion – OP[4x(4x5ml)] |
Zoledronic acid monohydrate | Change notification | 20.08.2025 | Production problem | Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion – OP5ml |
Methylphenidate hydrochloride | Change notification | 19.08.2025 | Other | Methylphenidate AL 18 mg prolonged-release tablets |
Paliperidone palmitate | Change notification | 19.08.2025 | Other | Paliperidone AL 150 mg depot injection suspension in a pre-filled syringe |
Ketotifen fumarate | Initial | 19.08.2025 | Production problem | Ketotifen STADA 1 mg hard capsules |
Quetiapine fumarate (Ph.Eur.) | Change notification | 19.08.2025 | Other | Seroquel Prolong 50 mg prolonged-release tablets |
Methylphenidate hydrochloride | Change notification | 19.08.2025 | Other | METHYLPHENI TAD 10 mg tablets |
Vincristine sulfate | Change notification | 19.08.2025 | Production problem | Vincristine sulfate-TEVA 1 mg/ml injection solution |
Phenytoin sodium | Initial | 19.08.2025 | Production problem | Phenhydan injection solution |
Quetiapine fumarate (Ph.Eur.) | Change notification | 19.08.2025 | Other | Seroquel Prolong 300 mg prolonged-release tablets |
Phenylephrine hydrochloride | Initial | 19.08.2025 | Production problem | Neosynephrine POS 5% |
Olanzapine embonate monohydrate | Change notification | 18.08.2025 | Production problem | ZYPADHERA 210 mg powder and solvent for the preparation of a depot injection suspension – OP(483mg+3ml) |
Olanzapine | Change notification | 18.08.2025 | Production problem | Zyprexa 7.5 mg coated tablets – OP70 (blister pack) |
Olanzapine embonate monohydrate | Change notification | 18.08.2025 | Production problem | ZYPADHERA 300 mg powder and solvent for the preparation of a depot injection suspension – OP(690mg+3ml) |
Norepinephrine hydrochloride/noradrenaline hydrochloride | Change notification | 18.08.2025 | Production problem | Arterenol 1 ml |
Baclofen | Initial | 18.08.2025 | Other | Lioresal Intrathecal 0.05 mg/1 ml solution for injection |
Primidone | Initial | 18.08.2025 | Production problem | Mylepsinum |