| ALTUVOCT 2 000 IU Powder and solvent for solution for injection EU/1/24/1824/005 |
Efanesoctocog alfa |
Swedish Orphan Biovitrum AB(publ) |
— |
| ALTUVOCT 250 IU Powder and solvent for solution for injection EU/1/24/1824/001 |
Efanesoctocog alfa |
Swedish Orphan Biovitrum AB(publ) |
— |
| ALTUVOCT 3 000 IU Powder and solvent for solution for injection EU/1/24/1824/006 |
Efanesoctocog alfa |
Swedish Orphan Biovitrum AB(publ) |
— |
| ALTUVOCT 4 000 IU Powder and solvent for solution for injection EU/1/24/1824/007 |
Efanesoctocog alfa |
Swedish Orphan Biovitrum AB(publ) |
— |
| ALTUVOCT 500 IU Powder and solvent for solution for injection EU/1/24/1824/002 |
Efanesoctocog alfa |
Swedish Orphan Biovitrum AB(publ) |
— |
| ALTUVOCT 750 IU Powder and solvent for solution for injection EU/1/24/1824/003 |
Efanesoctocog alfa |
Swedish Orphan Biovitrum AB(publ) |
— |
| Alunbrig 180 mg film-coated tablets EU/1/18/1264/009-010 |
Brigatinib |
Takeda Pharma A/S |
— |
| Alunbrig 30 mg film-coated tablets EU/1/18/1264/001-004 |
Brigatinib |
Takeda Pharma A/S |
— |
| Alunbrig 90 mg film-coated tablets EU/1/18/1264/005-008 |
Brigatinib |
Takeda Pharma A/S |
— |
| ALUTARD SQ Bee 100 000 SQ-U/ml suspension for injection PA1255/008/001 |
Apis mellifera |
ALK-Abello A/S |
Marketed |
| ALUTARD SQ Bee Initial Pack (100 SQ-U/ml, 1 000 SQ-U/ml, 10 000 SQ-U/ml and 100 000 SQ-U/ml) suspension for injection PA1255/008/002 |
Apis mellifera, Apis mellifera, Apis mellifera, Apis mellifera |
ALK-Abello A/S |
Marketed |
| ALUTARD SQ Wasp 100 000 SQ-U/ml suspension for injection PA1255/009/001 |
Vespula spp. |
ALK-Abello A/S |
Marketed |
| ALUTARD SQ Wasp Initial Pack (100 SQ-U/ml, 1 000 SQ-U/ml, 10 000 SQ-U/ml and 100 000 SQ-U/ml) suspension for injection PA1255/009/002 |
Vespula spp., Vespula spp., Vespula spp., Vespula spp. |
ALK-Abello A/S |
Marketed |
| Alvesco 160 microgram pressurised inhalation, solution PPA0465/515/001 |
Ciclesonide |
PCO Manufacturing Ltd. |
— |
| Alvesco 160 micrograms pressurised inhalation, solution PA22986/001/002 |
Ciclesonide |
Covis Pharma Europe B.V. |
Marketed |
| Alvesco 160 micrograms pressurised inhalation, solution PPA1463/175/001 |
Ciclesonide |
IMED Healthcare Ltd., |
— |
| Alvesco 80 micrograms pressurised inhalation, solution PA22986/001/001 |
Ciclesonide |
Covis Pharma Europe B.V. |
Marketed |
| Alyftrek 125 mg/50 mg/10 mg film-coated tablets EU/1/25/1943/002 |
Vanzacaftor, TEZACAFTOR, Deutivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Alyftrek 50 mg/20 mg/4 mg film-coated tablets EU/1/25/1943/001 |
Vanzacaftor, TEZACAFTOR, Deutivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Alymsys 25 mg/mL concentrate for solution for infusion EU/1/20/1509/001-002 |
Bevacizumab |
Mabxience Research, S.L. |
— |
| Amantadine hydrochloride Renata 100 mg Capsules, hard PA22865/005/001 |
AMANTADINE HYDROCHLORIDE |
Renata Pharmaceuticals (Ireland) Limited |
Marketed |
| Ambirix suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed) EU/1/02/224/005 |
Hepatitis b surface antigen (hbs ag), Hepatitis a virus |
GlaxoSmithKline Biologicals S.A. |
— |
| Ambirix Suspension for injection in pre-filled syringeHepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed) EU/1/02/224/001 |
Hepatitis b surface antigen (hbs ag), Hepatitis a virus |
GlaxoSmithKline Biologicals S.A. |
— |
| Ambirix Suspension for injection in pre-filled syringeHepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed) EU/1/02/224/002 |
Hepatitis b surface antigen (hbs ag), Hepatitis a virus |
GlaxoSmithKline Biologicals S.A. |
— |
| Ambirix, suspension for injection in pre-filled syringeHepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed) EU/1/02/224/003 |
Hepatitis a virus, Hepatitis b surface antigen (hbs ag) |
GlaxoSmithKline Biologicals S.A. |
— |
| Ambirix, suspension for injection in pre-filled syringeHepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed) EU/1/02/224/004 |
Hepatitis a virus, Hepatitis b surface antigen (hbs ag) |
GlaxoSmithKline Biologicals S.A. |
— |
| AmBisome Liposomal Amphotericin B 50 mg Powder for Concentrate for Dispersion for Infusion PA2322/001/001 |
Amphotericin b |
Gilead Sciences Ireland UC |
Marketed |
| Ambrisentan Accord 10 mg film-coated tablets PA2315/235/002 |
Ambrisentan |
Accord Healthcare Ireland Ltd. |
Marketed |
| Ambrisentan Accord 5 mg film-coated tablets PA2315/235/001 |
Ambrisentan |
Accord Healthcare Ireland Ltd. |
Marketed |
| Ambrisentan Viatris 10 mg film-coated tablets EU/1/19/1368/003-004 |
Ambrisentan |
Viatris Limited |
— |
| Ambrisentan Viatris 5 mg film-coated tablets EU/1/19/1368/001-002 |
Ambrisentan |
Viatris Limited |
— |
| Ameluz 78 mg/g gel EU/1/11/740/001 |
5-aminolevulinic acid hydrochloride |
Biofrontera Bioscience GmbH |
— |
| Ametop 40 mg/g Gel PA2325/002/001 |
Tetracaine base |
Alliance Pharma (Ireland) Limited |
Marketed |
| AMGEVITA 20 mg solution for injection in pre-filled syringe EU/1/16/1164/001 |
Adalimumab |
Amgen Europe B.V., |
— |
| AMGEVITA 20 mg solution for injection in pre-filled syringe EU/1/16/1164/010 |
Adalimumab |
Amgen Europe B.V., |
— |
| AMGEVITA 40 mg solution for injection in pre-filled pen EU/1/16/1164/014- 016 |
Adalimumab |
Amgen Europe B.V., |
— |
| AMGEVITA 40 mg solution for injection in pre-filled syringe EU/1/16/1164/002-009 |
Adalimumab |
Amgen Europe B.V., |
— |
| AMGEVITA 40 mg solution for injection in pre-filled syringe EU/1/16/1164/011-013 |
Adalimumab |
Amgen Europe B.V., |
— |
| AMGEVITA 80 mg solution for injection in pre-filled pen EU/1/16/1164/020- 022 |
Adalimumab |
Amgen Europe B.V., |
— |
| AMGEVITA 80 mg solution for injection in pre-filled syringe EU/1/16/1164/017-019 |
Adalimumab |
Amgen Europe B.V., |
— |
| AMGLIDIA 0.6 mg/mL oral suspension EU/1/18/1279/001-002 |
Glibenclamide |
AMMTek |
— |
| AMGLIDIA 6 mg/mL oral suspension EU/1/18/1279/003-004 |
Glibenclamide |
AMMTek |
— |
| AMIDAFLUID 1 mg/ml, eye drops, solution PA23520/001/001 |
Propamidine isetionate |
Horus Pharma |
Not marketed |
| Amidex 1 mg film-coated tablets PA0126/189/001 |
Anastrozole |
Clonmel Healthcare Ltd |
Marketed |
| Amifampridine SERB 10 mg tablets EU/1/22/1646/001-003 |
Amifampridine Phosphate |
SERB S.A. |
— |
| Amikacin 125 mg/ml Solution for injection/infusion PA1122/034/001 |
AMIKACIN SULFATE |
Noridem Enterprises Limited |
Not marketed |
| Amikacin 250 mg/ ml Solution for injection/infusion PA1418/012/001 |
AMIKACIN SULFATE |
Athlone Pharmaceuticals Limited |
Not marketed |
| Amikacin 250 mg/ml Solution for injection/infusion PA1122/034/002 |
AMIKACIN SULFATE |
Noridem Enterprises Limited |
Not marketed |
| Amikacin 5 mg/ml solution for infusion PA2059/072/001 |
Amikacin |
Fresenius Kabi Deutschland GmbH |
Marketed |
| Amikacin Caragen 250 mg/ml solution for injection/infusion PA22939/001/001 |
Amikacin |
Caragen Limited |
Marketed |