| Montelukast Bluefish 10 mg Film-coated Tablets PA1436/032/001 |
Montelukast sodium |
Bluefish Pharmaceuticals AB |
Marketed |
| Montelukast Bluefish 4 mg chewable tablets PA1436/033/001 |
Montelukast |
Bluefish Pharmaceuticals AB |
Marketed |
| Montelukast Bluefish 5 mg chewable tablets PA1436/033/002 |
Montelukast |
Bluefish Pharmaceuticals AB |
Marketed |
| Montelukast Paediatric 4mg Chewable Tablets PA2315/110/001 |
Montelukast |
Accord Healthcare Ireland Ltd. |
Marketed |
| MONTELUKAST Paediatric 5 mg Chewable Tablets PA1445/015/003 |
Montelukast sodium |
Aurobindo Pharma (Malta) Limited |
Not marketed |
| Montelukast Paediatric 5mg Chewable Tablets PA2315/110/002 |
Montelukast |
Accord Healthcare Ireland Ltd. |
Marketed |
| Montelukast Pinewood 10 mg Tablets PA0281/261/003 |
Montelukast sodium |
Pinewood Laboratories Limited |
Marketed |
| Montelukast Pinewood 4mg Chewable Tablets PA0281/261/001 |
Montelukast sodium |
Pinewood Laboratories Limited |
Not marketed |
| Montelukast Pinewood 5 mg Chewable Tablets PA0281/261/002 |
Montelukast sodium |
Pinewood Laboratories Limited |
Not marketed |
| Montelukast Teva 10 mg Film-coated Tablets PA0749/048/003 |
Montelukast sodium |
Teva Pharma B.V. |
Marketed |
| Montelukast Teva 4 mg Chewable Tablets PA0749/048/001 |
Montelukast sodium |
Teva Pharma B.V. |
Marketed |
| Montelukast Teva 4 mg GranulesFor children from 6 months to 5 years of age PA0749/048/004 |
Montelukast sodium |
Teva Pharma B.V. |
Marketed |
| Montelukast Teva 5 mg Chewable Tablets PA0749/048/002 |
Montelukast sodium |
Teva Pharma B.V. |
Marketed |
| Montelukast Viatris 10 mg film-coated tablets PA23266/025/001 |
Montelukast |
Viatris Limited |
Marketed |
| Montelukast Viatris 4 mg Chewable Tablets PA23266/022/001 |
Montelukast |
Viatris Limited |
Not marketed |
| Montelukast Viatris 5 mg Chewable Tablets PA23266/022/002 |
Montelukast |
Viatris Limited |
Not marketed |
| Nux vomica - Tablets HOR0407/016/001 |
Strychnos nux-vomica |
Weleda (UK) Limited |
— |
| Pyrukynd EU/1/22/1662/004-005 |
Mitapivat Sulfate |
Agios Netherlands B.V. |
— |
| Pyrukynd 5 mg film-coated tablets EU/1/22/1662/001-003 |
Mitapivat Sulfate |
Agios Netherlands B.V. |
— |
| Pyrukynd 50 mg film-coated tablets EU/1/22/1662/006 |
Mitapivat Sulfate |
Agios Netherlands B.V. |
— |
| Quadrivalent Influenza Vaccine (split virion, inactivated), suspension for injection in pre-filled syringe Quadrivalent influenza vaccine (split virion, inactivated) PA23458/010/001 |
A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238, B/Austria/1359417/2021 - like strain (B/Michigan/01/2021, wild type), B/PHUKET/3073/2013 -LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE), Influenza A virus, A/Croatia/10136RV/2023 (H3N2) like strain X-425A, Inactivated |
Sanofi Winthrop Industrie |
Not marketed |
| Rukobia 600 mg prolonged-release tablets EU/1/20/1518/001 |
Fostemsavir Tromethamine |
ViiV Healthcare BV |
— |
| RXULTI 0.25 mg Film-coated tablet EU/1/18/1294/001 |
Brexpiprazole |
Otsuka Pharmaceutical Netherlands B.V. |
— |
| RXULTI 0.5 mg Film-coated tablet EU/1/18/1294/002 |
Brexpiprazole |
Otsuka Pharmaceutical Netherlands B.V. |
— |
| RXULTI 1 mg Film-coated tablet EU/1/18/1294/003-004 |
Brexpiprazole |
Otsuka Pharmaceutical Netherlands B.V. |
— |
| RXULTI 2 mg Film-coated tablet EU/1/18/1294/005 |
Brexpiprazole |
Otsuka Pharmaceutical Netherlands B.V. |
— |
| RXULTI 3 mg Film-coated tablet EU/1/18/1294/006 |
Brexpiprazole |
Otsuka Pharmaceutical Netherlands B.V. |
— |
| RXULTI 4 mg Film-coated tablet EU/1/18/1294/007 |
Brexpiprazole |
Otsuka Pharmaceutical Netherlands B.V. |
— |
| Samsca 15 mg Tablet EU/1/09/539/1-2 |
Tolvaptan |
Otsuka Pharmaceutical Netherlands B.V. |
— |
| Samsca 30 mg Tablet EU/1/09/539/3-4 |
Tolvaptan |
Otsuka Pharmaceutical Netherlands B.V. |
— |
| Samsca 7.5 mg Tablet EU/1/09/539/005-006 |
Tolvaptan (opc-41061) |
Otsuka Pharmaceutical Netherlands B.V. |
— |
| Singulair 10 mg film-coated tablets PA23198/014/004 |
Montelukast sodium |
Organon Pharma (Ireland) Limited |
Marketed |
| Singulair 10 mg film-coated tablets PPA0465/111/001 |
Montelukast |
PCO Manufacturing Ltd. |
— |
| Singulair 10 mg film-coated tablets PPA1463/064/003 |
Montelukast |
IMED Healthcare Ltd., |
— |
| Singulair Paediatric 4 mg chewable tablets PA23198/014/001 |
Montelukast |
Organon Pharma (Ireland) Limited |
Not marketed |
| Singulair Paediatric 5 mg chewable tablets PA23198/014/003 |
Montelukast sodium |
Organon Pharma (Ireland) Limited |
Marketed |
| Singulair Paediatric 5 mg chewable tablets PPA0465/111/002 |
Montelukast sodium |
PCO Manufacturing Ltd. |
— |
| Singulair Paediatric 5 mg Chewable Tablets PPA1463/064/002 |
Montelukast |
IMED Healthcare Ltd., |
— |
| TUKYSA 150 mg film-coated tablets EU/1/20/1526/002 |
Tucatinib |
Pfizer Europe MA EEIG |
— |
| TUKYSA 50 mg film-coated tablets EU/1/20/1526/001 |
Tucatinib |
Pfizer Europe MA EEIG |
— |
| Tyruko 300 mg concentrate for solution for infusion EU/1/23/1745/001 |
Natalizumab |
Polpharma Biologics S.A. |
— |
| Valdrian hard capsules TR25313/001/001 |
|
HUK Europe Limited |
Not marketed |