| Levobupivacaine 5.0 mg/mL solution for injection/infusion PA2059/009/004 |
Levobupivacaine |
Fresenius Kabi Deutschland GmbH |
Marketed |
| Levobupivacaine 7.5 mg/mL solution for injection/infusion PA2059/009/005 |
Levobupivacaine |
Fresenius Kabi Deutschland GmbH |
Marketed |
| Libmeldy 2-10 x 106 cells/mL dispersion for infusion EU/1/20/1493/001 |
Autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the Human Arylsulfatase a Gene |
Orchard Therapeutics (Netherlands) B.V. |
— |
| Lidocaine 10 mg/ml (1% w/v) solution for injection in pre-filled syringe PA1968/009/001 |
Lidocaine hydrochloride |
Laboratoire Aguettant |
Marketed |
| Lidocaine 20 mg/ml (2% w/v) solution for injection in pre-filled syringe PA1968/009/002 |
Lidocaine hydrochloride |
Laboratoire Aguettant |
Not marketed |
| Lidocaine Hydrochloride 1% w/v Solution for Injection PA2059/003/001 |
Lidocaine Hydrochloride Monohydrate |
Fresenius Kabi Deutschland GmbH |
Marketed |
| Lidocaine Hydrochloride 2% w/v Solution for Injection PA2059/003/002 |
Lidocaine Hydrochloride Monohydrate |
Fresenius Kabi Deutschland GmbH |
Marketed |
| Lidocaine hydrochloride 20 mg/ml, solution for injection/infusion PA1968/012/001 |
Lidocaine Hydrochloride Monohydrate |
Laboratoire Aguettant |
Not marketed |
| Lidocaine hydrochloride Noridem 10 mg/ml (1 % w/v) solution for injection PA1122/027/001 |
Lidocaine Hydrochloride Monohydrate |
Noridem Enterprises Limited |
Not marketed |
| Lidocaine hydrochloride Noridem 20 mg/ml (2 % w/v) solution for injection PA1122/027/002 |
Lidocaine Hydrochloride Monohydrate |
Noridem Enterprises Limited |
Not marketed |
| Lidocaine/Adrenaline (Epinephrine) 10 mg/ml + 5 microgram/ml solution for injection PA1968/027/001 |
Lidocaine Hydrochloride Monohydrate, Adrenaline tartrate |
Laboratoire Aguettant |
Marketed |
| Lidocaine/Adrenaline (Epinephrine) 20 mg/ml + 5 microgram/ml solution for injection PA1968/027/002 |
Lidocaine Hydrochloride Monohydrate, Adrenaline tartrate |
Laboratoire Aguettant |
Marketed |
| Lignospan Special (20 mg/12.5 microgram per ml) Solution for Injection 1.8 ml PA0196/013/001 |
Adrenaline (epinephrine), Lidocaine hydrochloride |
Septodont |
Marketed |
| Lignospan Special (20 mg/12.5 microgram per ml) Solution for Injection 2.2 ml PA0196/013/002 |
Lidocaine hydrochloride, Adrenaline (epinephrine) |
Septodont |
Marketed |
| Lixiana 15 mg film-coated tablets EU/1/15/993/001 |
Edoxaban tosilate |
Daiichi Sankyo Europe GmbH |
— |
| Lixiana 30 mg film-coated tablets EU/1/15/993/002 |
Edoxaban tosilate |
Daiichi Sankyo Europe GmbH |
— |
| Lixiana 60 mg film-coated tablets EU/1/15/993/003 |
Edoxaban tosilate |
Daiichi Sankyo Europe GmbH |
— |
| Loceryl 5% w/v Medicated Nail Lacquer PA22743/009/001 |
Amorolfine |
Galderma International |
Marketed |
| Loceryl 5% w/v Medicated Nail Lacquer PPA0465/234/001 |
Amorolfine |
PCO Manufacturing Ltd. |
— |
| Loceryl 5% w/v Medicated Nail Lacquer PPA1463/081/001 |
Amorolfine |
IMED Healthcare Ltd., |
— |
| Lytgobi 4 mg film-coated tablet EU/1/23/1741/001-003 |
Futibatinib |
Taiho Pharma Netherlands B.V. |
— |
| M-M-RvaxPro powder and solvent for suspension for injection Measles, mumps and rubella vaccine (live) EU/1/06/337/1-13 |
Mumps virus live attenuated jeryl lynn strain, Rubella virus (wistar ra 27/3 strain) live attenuated, Measles virus live attenuated derived from the edmonston b strain |
Merck Sharp & Dohme BV, |
— |
| Maintelyte solution for infusion PA2299/045/001 |
Sodium chloride, GLUCOSE MONOHYDRATE PH. EUR., Sodium acetate, trihydrate, POTASSIUM CHLORIDE PH. EUR., MAGNESIUM CHLORIDE HEXAHYDRATE PH. EUR. |
Baxter Holding B.V. |
Marketed |
| Marcain 0.25% w/v with Adrenaline (Epinephrine, 5 micrograms per ml) (1:200,000) Solution for Injection PA1691/025/001 |
Bupivacaine hydrochloride, Adrenaline tartrate |
Aspen Pharma Trading Limited |
Marketed |
| Marcain 0.5% w/v with Adrenaline (Epinephrine, 5 micrograms per ml) (1:200,000) Solution for Injection PA1691/025/002 |
Adrenaline tartrate, Bupivacaine hydrochloride |
Aspen Pharma Trading Limited |
Not marketed |
| Marcain Heavy Steripack 0.5% w/v Solution for Injection PA1691/024/003 |
Bupivacaine hydrochloride |
Aspen Pharma Trading Limited |
Marketed |
| Marcain Polyamp Steripack 0.25% w/v Solution for Injection PA1691/024/001 |
Bupivacaine hydrochloride |
Aspen Pharma Trading Limited |
Marketed |
| Marcain Polyamp Steripack 0.5% w/v Solution for Injection PA1691/024/002 |
Bupivacaine hydrochloride |
Aspen Pharma Trading Limited |
Not marketed |
| mCOMBRIAX dispersion for injection in pre-filled syringe. Influenza and COVID-19, mRNA vaccine. EU/1/26/2028/001-002 |
mRNA encoding Influenza A, H1N1 strain, hemagglutinin glycoprotein, mRNA encoding Influenza A, H3N2 strain, hemagglutinin glycoprotein, mRNA encoding Influenza B/Victoria, hemagglutinin glycoprotein, mRNA-1283 |
Moderna Biotech Spain S.L. |
— |
| Medical Air PA0208/009/001 |
Oxygen |
BOC Gases Ireland Ltd |
Marketed |
| Medical Liquid Oxygen 100% Medicinal gas, cryogenic PA22852/001/002 |
Oxygen |
Air Liquide Healthcare Ireland Limited |
Not marketed |
| Medical Oxygen PA22852/001/001 |
Oxygen |
Air Liquide Healthcare Ireland Limited |
Marketed |
| Medicinal air synthetic SOL 21.75% v/v medicinal gas, compressed PA1848/002/001 |
Oxygen |
SOL S.p.A. |
— |
| Medijel oromucosal gel Lidocaine hydrochloride 0.66% w/w Aminoacridine hydrochloride 0.05% w/w PA1113/022/001 |
Aminacrine hydrochloride, Lignocaine hydrochloride |
Phoenix Labs |
Marketed |
| Medispray oromucosal spray, solution, Chlorhexidine digluconate 2 mg/ml, Lidocaine hydrochloride monohydrate 0.5 mg/ml PA0126/300/001 |
Lidocaine hydrochloride, Chlorhexidine digluconate |
Clonmel Healthcare Ltd |
— |
| Menveo EU/1/10/614/002-004 |
N. MENINGITIDIS GROUP A OLIGOSACCHARIDE CONJUGATED CRM197, N. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE CONJUGATED CRM197, N. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE CONJUGATED CRM197, MENINGOCOCCAL GROUP Y OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN |
Glaxosmithkline Vaccines S.r.l. |
— |
| Minims Lidocaine Hydrochloride 4% w/v & Fluorescein Sodium 0.25% w/v Eye Drops, solution PA23259/014/001 |
Fluorescein sodium, Lidocaine hydrochloride |
Bausch + Lomb Ireland Limited |
Marketed |
| Minims Oxybuprocaine Hydrochloride 0.4% w/v Eye Drops Solution PA23259/015/001 |
Oxybuprocaine hydrochloride |
Bausch + Lomb Ireland Limited |
Marketed |
| Minims Proxymetacaine hydrochloride 0.5% w/v, Eye Drops, Solution PA23259/020/001 |
PROXYMETACAINE HYDROCHLORIDE |
Bausch + Lomb Ireland Limited |
Marketed |
| Minims Tetracaine Hydrochloride 0.5% w/v Eye Drops, Solution PA23259/022/001 |
Tetracaine hydrochloride |
Bausch + Lomb Ireland Limited |
Not marketed |
| Minims Tetracaine Hydrochloride 1% w/v Eye Drops, Solution PA23259/022/002 |
Tetracaine hydrochloride |
Bausch + Lomb Ireland Limited |
Marketed |
| mNEXSPIKE dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine EU/1/25/2010/001-006 |
mRNA-1283 |
Moderna Biotech Spain S.L. |
— |
| Monopost Unidose 50 micrograms/ml eye drops, solution in single-dose container PA1107/007/001 |
Latanoprost |
Laboratoires Thea |
Marketed |
| Monopost Unidose 50 micrograms/ml eye drops, solution in single-dose container PPA0465/449/001 |
Latanoprost |
PCO Manufacturing Ltd. |
— |
| Montelair 10 mg Film-coated Tablets PA0126/215/003 |
Montelukast |
Clonmel Healthcare Ltd |
Marketed |
| Montelair 4 mg Chewable Tablets PA0126/215/001 |
Montelukast |
Clonmel Healthcare Ltd |
Marketed |
| Montelair 5 mg Chewable Tablets PA0126/215/002 |
Montelukast |
Clonmel Healthcare Ltd |
Marketed |
| Movicol Paediatric Plain 6.9 g sachet powder for oral solution PA23265/001/003 |
Macrogol 3350, Sodium bicarbonate, Sodium chloride, Potassium chloride |
Norgine Healthcare B.V. |
Marketed |
| Movicol Plain 13.7 g sachet powder for oral solution PA23265/001/004 |
Macrogol 3350, Sodium bicarbonate, Sodium chloride, Potassium chloride |
Norgine Healthcare B.V. |
Not marketed |
| mRESVIA EU/1/24/1849/001-002 |
Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation |
Moderna Biotech Spain S.L. |
— |