| Paliperidone palmitate | Initial report | 19.09.2025 | Other | XEPLION 25 mg depot injection suspension – OP1ml |
| Beclomethasone dipropionate (Ph.Eur.) | Change notification | 19.09.2025 | Other | Beclorhinol aquosum 50 micrograms |
| Quetiapine fumarate (Ph.Eur.) | Initial report | 19.09.2025 | Other | Seroquel Prolong 200 mg prolonged-release tablets |
| Olanzapine embonate monohydrate | Change notification | 19.09.2025 | Production problem | ZYPADHERA 405 mg powder and solvent for the preparation of a prolonged-release suspension for injection – OP(931mg+3ml) |
| Paliperidone palmitate | Change notification | 19.09.2025 | Production problem | Paliperidone Advanz Pharma 50 mg prolonged-action injection suspension in a pre-filled syringe |
| Paliperidone palmitate | Change notification | 19.09.2025 | Production problem | Paliperidone Advanz Pharma 25 mg prolonged-release injection suspension in a pre-filled syringe |
| Naloxegol oxalate | Change notification | 19.09.2025 | Other | Moventig 25 mg film-coated tablets – OP100(100×1) |
| Naloxone hydrochloride dihydrate; oxycodone hydrochloride monohydrate | Initial report | 19.09.2025 | Production problem | Targin 60 mg/30 mg prolonged-release tablets |
| Oxycodone hydrochloride | Change notification | 18.09.2025 | Other | OXYGESIC 10 mg |
| Ciprofloxacin hydrochloride monohydrate | Change notification | 18.09.2025 | Other | CIPRO BASICS 250 mg film-coated tablets |
| Ciprofloxacin hydrochloride monohydrate | Initial report | 18.09.2025 | Other | CIPRO BASICS 750 mg film-coated tablets |
| Flecainide acetate | Change notification | 18.09.2025 | Other | Tambocor |
| Tobramycin | Change notification | 18.09.2025 | Production problem | TOBI Podhaler 28 mg hard capsules with powder for inhalation – OP224(4×56) |
| Azithromycin dihydrate | Change notification | 18.09.2025 | Other | Azithromycin AL 250 mg film-coated tablets |
| Clonidine hydrochloride | Initial report | 18.09.2025 | Production problem | Clonistada 0.15 mg tablets |
| Ipratropium bromide (Ph.Eur.) | Change notification | 18.09.2025 | Production problem | Ipratropium Teva 250 micrograms/1 ml solution for nebulizer |
| Galantamine hydrobromide | Change notification | 18.09.2025 | Other | Galantamine-ratiopharm 8 mg hard capsules, delayed release |
| Rizatriptan benzoate | Change notification | 17.09.2025 | Production problem | Rizatriptan Glenmark 5 mg tablets |
| Rizatriptan benzoate | Change notification | 17.09.2025 | Production problem | Rizatriptan Glenmark 5 mg orodispersible tablets |
| Rizatriptan benzoate | Change notification | 17.09.2025 | Production problem | Rizatriptan Glenmark 10 mg orodispersible tablets |
| Rizatriptan benzoate | Change notification | 17.09.2025 | Production problem | Rizatriptan Glenmark 10 mg tablets |
| Quetiapine fumarate (Ph.Eur.) | Change notification | 17.09.2025 | Production problem | Quetiapine Glenmark 200 mg prolonged-release tablets |
| Quetiapine fumarate (Ph.Eur.) | Initial report | 17.09.2025 | Production problem | Quetiapine Glenmark 300 mg prolonged-release tablets |
| Mometasone furoate (Ph.Eur.) | Change notification | 17.09.2025 | Production problem | Mometasone Glenmark 1 mg/g ointment |
| Linezolid | Change notification | 17.09.2025 | Production problem | Linezolid Glenmark 600 mg film-coated tablets |
| Nitrendipine | Initial report | 17.09.2025 | Other | Nitrendipine AbZ 20 mg tablets |
| Nitrendipine | Initial report | 17.09.2025 | Other | Nitrendipine AbZ 10 mg tablets |
| Nitrendipine | Initial report | 17.09.2025 | Other | Nitrendipine-ratiopharm 20 mg tablets |
| Nitrendipine | Initial report | 17.09.2025 | Other | Nitrendipine-ratiopharm 10 mg tablets |
| Nitrendipine | Initial report | 17.09.2025 | Other | Nitrendipine AL 20 |
| Nitrendipine | Initial report | 17.09.2025 | Other | Nitrendipine AL 10 |
| Misoprostol | Initial report | 17.09.2025 | Other | Angusta 25 microgram tablets |
| Atorvastatin calcium trihydrate (Ph.Eur.) | Change notification | 17.09.2025 | Other | Atorvastatin Aristo 60 mg film-coated tablets |
| Trandolapril | Change notification | 17.09.2025 | Other | Udrik 0.5 mg |
| Fluoxetine hydrochloride | Change notification | 16.09.2025 | Other | Fluoxetine Micro Labs 10 mg hard capsules |
| Fluoxetine hydrochloride | Change notification | 16.09.2025 | Other | Fluoxetine Micro Labs 20 mg hard capsules |
| Fluoxetine hydrochloride | Change notification | 16.09.2025 | Other | Fluoxetine Micro Labs 30 mg hard capsules |
| Fluoxetine hydrochloride | Change notification | 16.09.2025 | Other | Fluoxetine Micro Labs 40 mg hard capsules |
| Fluoxetine hydrochloride | Change notification | 16.09.2025 | Other | Fluoxetine Micro Labs 60 mg hard capsules |
| Aprepitant | Change notification | 16.09.2025 | Other | Aprepitant AL 125 mg hard capsules |
| Rifampicin sodium | Initial report | 16.09.2025 | Production problem | Eremfat IV 300 mg |
| Trandolapril; verapamil hydrochloride | Change notification | 16.09.2025 | Other | Tarka 180 mg/2 mg modified-release tablets |
| Sufentanil citrate | Change notification | 15.09.2025 | Production problem | Sufenta 50 micrograms/ml solution for injection |
| Isosorbide mononitrate | Change notification | 15.09.2025 | Production problem | ISMN STADA 20 mg tablets |
| Atorvastatin calcium trihydrate (Ph.Eur.) | Change notification | 15.09.2025 | Production problem | Atorvastatin STADA 80 mg film-coated tablets |
| Aprepitant | Change notification | 15.09.2025 | Production problem | Aprepitant STADA 125 mg hard capsules |
| Doxylamine hydrogen succinate | Change notification | 15.09.2025 | Production problem | Hoggar Night 25 mg orodispersible tablets |
| Flucloxacillin sodium 1 H<2>O | Change notification | 15.09.2025 | Production problem | Staphylex 250 mg capsules |
2025年9月22日