| Active ingredients | | Date of last message | Type of reason | AM designation |
| Pramipexole dihydrochloride monohydrate | Change notification | 10.08.2025 | Other | Pramipexole PUREN 0.18 mg tablets |
| Atorvastatin calcium trihydrate (Ph.Eur.) | Change notification | 10.08.2025 | Other | Atorvastatin PUREN 10 mg film-coated tablets |
| Atorvastatin calcium trihydrate (Ph.Eur.) | Change notification | 10.08.2025 | Other | Atorvastatin PUREN 20 mg film-coated tablets |
| Paliperidone palmitate | Change notification | 08.08.2025 | Other | Paliperidone AL 150 mg depot injection suspension in a pre-filled syringe |
| Quetiapine fumarate (Ph.Eur.) | Change notification | 08.08.2025 | Other | Quetiapine-neuraxpharm 600 mg prolonged-release tablets |
| Quetiapine fumarate (Ph.Eur.) | Change notification | 08.08.2025 | Other | Quetiapine-neuraxpharm 400 mg prolonged-release tablets |
| Quetiapine fumarate (Ph.Eur.) | Change notification | 08.08.2025 | Other | Quetiapine-neuraxpharm 300 mg prolonged-release tablets |
| Quetiapine fumarate (Ph.Eur.) | Change notification | 08.08.2025 | Other | Quetiapine-neuraxpharm 200 mg prolonged-release tablets |
| Quetiapine fumarate (Ph.Eur.) | Change notification | 08.08.2025 | Other | Quetiapine-neuraxpharm 150 mg prolonged-release tablets |
| Quetiapine fumarate (Ph.Eur.) | Change notification | 08.08.2025 | Other | Quetiapine-neuraxpharm 50 mg prolonged-release tablets |
| Levomepromazine hydrochloride | Initial report | 08.08.2025 | Other | Levomepromazine-neuraxpharm 25 mg/ml solution for injection |
| Phenobarbital | Change notification | 08.08.2025 | Production problem | Phenobarbital-neuraxpharm 100 mg |
| Phenobarbital | Change notification | 08.08.2025 | Production problem | Phenobarbital-neuraxpharm 15 mg |
| Methylphenidate hydrochloride | Change notification | 08.08.2025 | Other | Methylphenidate hydrochloride-neuraxpharm 27 mg prolonged-release tablets |
| Haloperidol decanoate | Change notification | 08.08.2025 | Production problem | Haloperidol-neuraxpharm decanoate 100 mg/ml |
| Haloperidol decanoate | Change notification | 08.08.2025 | Production problem | Haloperidol-neuraxpharm decanoate 50 mg/ml |
| Galantamine hydrobromide | Change notification | 08.08.2025 | Other | Galantamine-neuraxpharm 24 mg hard capsules, delayed release |
| Galantamine hydrobromide | Change notification | 08.08.2025 | Other | Galantamine-neuraxpharm 16 mg Hard capsules, delayed release |
| Galantamine hydrobromide | Change notification | 08.08.2025 | Other | Galantamine-neuraxpharm 8 mg hard capsules, delayed release |
| Atomoxetine hydrochloride | Change notification | 08.08.2025 | Production problem | Atomoxetine-neuraxpharm 100 mg hard capsules |
| Atomoxetine hydrochloride | Change notification | 08.08.2025 | Production problem | Atomoxetine-neuraxpharm 80 mg hard capsules |
| Atomoxetine hydrochloride | Change notification | 08.08.2025 | Production problem | Atomoxetine-neuraxpharm 40 mg hard capsules |
| Atomoxetine hydrochloride | Change notification | 08.08.2025 | Production problem | Atomoxetine-neuraxpharm 25 mg hard capsules |
| Atomoxetine hydrochloride | Change notification | 08.08.2025 | Production problem | Atomoxetine-neuraxpharm 18 mg hard capsules |
| Atomoxetine hydrochloride | Change notification | 08.08.2025 | Production problem | Atomoxetine-neuraxpharm 10 mg hard capsules |
| Atomoxetine hydrochloride | Change notification | 08.08.2025 | Production problem | Atomoxetine-neuraxpharm 60 mg hard capsules |
| Nintedanib | Initial report | 07.08.2025 | Other | Ofev |
| Von Willebrand factor | Initial report | 07.08.2025 | Other | WILLFACT 1000 IU |
| Fusidic acid (Ph.Eur.) | Change notification | 07.08.2025 | Production problem | Fucithalmic 10 mg/g eye drops |
| Calcium acetate hydrate ((with information on water content (1:x))) | Change notification | 07.08.2025 | Production problem | Renacet 950 mg |
| Quetiapine fumarate (Ph.Eur.) | Change notification | 07.08.2025 | Other | Seroquel Prolong 50 mg prolonged-release tablets |
| Fluoxetine hydrochloride | Initial report | 06.08.2025 | Other | Fluoxetine Micro Labs 60 mg hard capsules |
| Fluoxetine hydrochloride | Initial report | 06.08.2025 | Other | Fluoxetine Micro Labs 40 mg hard capsules |
| Fluoxetine hydrochloride | Initial report | 06.08.2025 | Other | Fluoxetine Micro Labs 30 mg hard capsules |
| Fluoxetine hydrochloride | Initial report | 06.08.2025 | Other | Fluoxetine Micro Labs 20 mg hard capsules |
| Fluoxetine hydrochloride | Initial report | 06.08.2025 | Other | Fluoxetine Micro Labs 10 mg hard capsules |
| Trandolapril; verapamil hydrochloride | Change notification | 06.08.2025 | Other | Tarka 180 mg/ 2 mg modified-release tablets |
| Brivaracetam | Change notification | 06.08.2025 | Production problem | Briviact 50 mg film-coated tablets – OP56 |
| Quetiapine fumarate (Ph.Eur.) | Change notification | 06.08.2025 | Other | Seroquel Prolong 400 mg prolonged-release tablets |
| Cinacalcet hydrochloride | Change notification | 06.08.2025 | Other | Cinacalcet-ratiopharm 30 mg film-coated tablets |
| Atorvastatin hemicalcium | Change notification | 06.08.2025 | Other | Atorvastatin – 1A Pharma 80 mg film-coated tablets |
| Atorvastatin calcium trihydrate (Ph.Eur.) | Initial | 06.08.2025 | Other | Atorvastatin-1A Pharma 20 mg film-coated tablets |
| Pramipexole dihydrochloride monohydrate | Change notification | 05.08.2025 | Production problem | Pramipexole STADA 0.52 mg prolonged-release tablets |
| Quetiapine fumarate (Ph.Eur.) | Change notification | 05.08.2025 | Other | Seroquel Prolong 300 mg prolonged-release tablets |
| Quetiapine fumarate (Ph.Eur.) | Change notification | 05.08.2025 | Other | Seroquel Prolong 200 mg prolonged-release tablets |
| Ipratropium bromide (Ph.Eur.); salbutamol sulfate | Change notification | 05.08.2025 | Production problem | COMBIPRASAL 0.5 mg / 2.5 mg solution for nebulizer |
| Reproterol hydrochloride | Change notification | 05.08.2025 | Production problem | Bronchospasmin 10 ml solution for injection |
| Tropicamide | Change notification | 05.08.2025 | Production problem | Mydriaticum Stulln UD |
| Carbamazepine | Initial | 05.08.2025 | Production problem | Tegretal 200 mg retard |
| Olanzapine embonate monohydrate | Change notification | 05.08.2025 | Production problem | ZYPADHERA 405 mg powder and solvent for the preparation of a depot injection suspension – OP (931 mg + 3 ml) |
| Insulin aspart | Change notification | 05.08.2025 | Other | NovoMix 30 FlexPen 100 IU/ml injection suspension in pre-filled syringe – OP(10x3ml) |
| Human insulin (with manufacturing details) | Change notification | 05.08.2025 | Other | Actrapid Penfill 100 IU/ml injection solution in cylinder ampoule – OP(10x3ml) |
| Olanzapine embonate monohydrate | Change notification | 05.08.2025 | Production problem | ZYPADHERA 300 mg powder and solvent for the preparation of a depot injection suspension – OP(690mg+3ml) |
| Isoniazid | Initial | 05.08.2025 | Other | Isozid 200 mg |
| Prednisolone acetate | Change notification | 05.08.2025 | Production problem | Prednifluid 10 mg/ml eye drop suspension |
| Atovaquone; proguanil hydrochloride | Initial | 04.08.2025 | Other | Malarone Junior film-coated tablets |
| Mupirocin calcium (Ph.Eur.) | Change notification | 04.08.2025 | Production problem | Turixin |
| Melperone hydrochloride | Change notification | 04.08.2025 | Production problem | Melperone Aristo 100 mg film-coated tablets |
| Paliperidone palmitate | Initial | 04.08.2025 | Other | Paliperidone AL 50 mg depot injection suspension in a pre-filled syringe |
| Iron (II) glycine sulfate complex | Change notification | 04.08.2025 | Production problem | Ferro sanol 30 mg/ml drops |
| Clarithromycin | Change notification | 04.08.2025 | Production problem | CLARITHROMYCIN BASICS 250 mg/5 ml granules for oral suspension |
| Esomeprazole hemimagnesium | Change notification | 04.08.2025 | Production problem | ESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules |
| Esomeprazole hemimagnesium | Change notification | 04.08.2025 | Production problem | ESOMEPRAZOLE BASICS 20 mg enteric-coated hard capsules |
| Fluoxetine hydrochloride | Change notification | 04.08.2025 | Production problem | Fluoxetine Stada 20 mg tablets for oral suspension |
| Gentamicin sulfate | Change notification | 04.08.2025 | Production problem | Gentamicin POS |