| Bupivacaine 5 mg/ml Solution for injection PA1122/029/002 |
Bupivacaine hydrochloride, anhydrous |
Noridem Enterprises Limited |
Not marketed |
| Bupivacaine 5 mg/ml Solution for Injection PA2299/035/002 |
Bupivacaine hydrochloride, monohydrate |
Baxter Holding B.V. |
Marketed |
| Bupivacaine Heavy 5 mg/ml solution for injection PA1968/025/001 |
Bupivacaine hydrochloride monohydrate |
Laboratoire Aguettant |
Marketed |
| Bupivacaine Hydrochloride 0.25% w/v Solution for Injection PA0073/091/001 |
Bupivacaine hydrochloride |
Mercury Pharmaceuticals (Ireland) Ltd |
Marketed |
| Bupivacaine Hydrochloride 0.5% w/v Solution for Injection PA0073/091/002 |
Bupivacaine hydrochloride |
Mercury Pharmaceuticals (Ireland) Ltd |
Marketed |
| Byfavo 20 mg powder for solution for injection EU/1/20/1505/001 |
Remimazolam besilate, Remimazolam (in house) |
Paion Pharma GmbH |
— |
| Byfavo 50 mg powder for concentrate for solution for injection/infusion EU/1/20/1505/002 |
Remimazolam besilate |
Paion Pharma GmbH |
— |
| Carbidopa/Levodopa Fair-Med 10 mg/100 mg Tablets PA1789/007/002 |
Levodopa, Carbidopa monohydrate |
Fairmed Healthcare GmbH |
Not marketed |
| Carbidopa/Levodopa Fair-Med 12.5mg/50mg Tablets PA1789/007/001 |
Levodopa, Carbidopa monohydrate |
Fairmed Healthcare GmbH |
Not marketed |
| Carbidopa/Levodopa Fair-Med 25 mg/100 mg Tablets PA1789/007/003 |
Levodopa, Carbidopa monohydrate |
Fairmed Healthcare GmbH |
Not marketed |
| Carbidopa/Levodopa Fair-Med 25 mg/250 mg Tablets PA1789/007/004 |
Levodopa, Carbidopa monohydrate |
Fairmed Healthcare GmbH |
Not marketed |
| Casacol Expectorant SyrupMethoxyphenamine hydrochloride 20 mg/5 ml Guaiphenesin 100 mg/5 ml Sodium Citrate 200 mg/5 ml PA1113/007/001 |
Methoxyphenamine hydrochloride, Sodium citrate, Guaiphenesin |
Phoenix Labs Unlimited Company |
Marketed |
| Celldemic suspension for injection in pre-filled syringe Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures). EU/1/24/1806/001 |
Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen |
Seqirus Netherlands B.V. |
— |
| CEVENFACTA 1 mg (45 KIU) powder and solvent for solution for injection EU/1/22/1664/001 |
Eptacog beta (activated) |
Laboratoire francais du Fractionnement et des Biotechnolgies |
— |
| CEVENFACTA 2 mg (90 KIU) powder and solvent for solution for injection EU/1/22/1664/002 |
Eptacog beta (activated) |
Laboratoire francais du Fractionnement et des Biotechnolgies |
— |
| CEVENFACTA 5 mg (225 KIU) powder and solvent for solution for injection EU/1/22/1664/003 |
Eptacog beta (activated) |
Laboratoire francais du Fractionnement et des Biotechnolgies |
— |
| Citanest with Octapressin Dental, Prilocaine Hydrochloride 3 % w/v, Felypressin 0.54 micrograms/ml Solution for Injection PA1045/001/001 |
Prilocaine hydrochloride, Felypressin |
DENTSPLY DeTrey GmbH |
Marketed |
| Curanail 5% w/v medicated nail lacquer PA22743/004/001 |
Amorolfine |
Galderma International |
Marketed |
| Cystadane 1g oral powder EU/1/06/379/001 |
Betaine anhydrous |
Recordati Rare Diseases |
— |
| Datroway 100 mg powder for concentrate for solution for infusion EU/1/25/1915/001 |
Datopotamab deruxtecan |
Daiichi Sankyo Europe GmbH |
— |
| Depo-Medrone 40mg/ml with Lidocaine 10mg/ml Suspension for Injection, 2ml vial PA0822/123/002 |
Methylprednisolone acetate, Lidocaine hydrochloride |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Dexafree 1 mg/ml eye drops, solution in single dose container PPA1463/193/001 |
DEXAMETHASONE PHOSPHATE |
IMED Healthcare Ltd. |
— |
| Dexafree 1mg/ml eye drops, solution in single dose container PA1107/005/001 |
DEXAMETHASONE PHOSPHATE |
Laboratoires Thea |
Marketed |
| Dexeta 1.37 mg/ml eye drops, solution in single dose container PA23335/001/001 |
Dexamethasone sodium phosphate |
SIFI S.p.A. |
Not marketed |
| Dolocopin 40mg/g Cream PA22869/001/001 |
Lidocaine |
Ferndale Laboratories Limited |
Not marketed |
| Dorzolamide/Timolol Brown & Burk 20 mg/ml + 5 mg/ml eye drops, solution in single-dose container PA23148/008/001 |
Dorzolamide hydrochloride, Timolol Maleate |
Brown & Burk IR Limited |
Not marketed |
| Duac Once Daily 10 mg/g + 50 mg/g gel PPA0465/517/001 |
Clindamycin, Anhydrous Benzoyl Peroxide |
PCO Manufacturing Ltd. |
— |
| Duac Once Daily 10mg/g + 50mg/g Gel PA1077/120/001 |
CLINDAMYCIN PHOSPHATE, Benzoyl peroxide hydrous |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Duaklir Genuair 340 micrograms /12 micrograms inhalation powder EU/1/14/964/001-003 |
Micronized aclidinium bromide, Micronized formoterol fumarate dihydrate |
Covis Pharma Europe B.V. |
— |
| Duelym 0.1 mg/g + 1 mg/g eye gel in single dose container PA1107/020/001 |
Bimatoprost, Timolol Maleate |
Laboratoires Thea |
Not marketed |
| Efluelda suspension for injection in pre-filled syringe Trivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain PA23458/001/001 |
Influenza Inactivated Split Virus Strain A (H1N1), Influenza Inactivated Split Virus Strain A (H3N2), Influenza Inactivated Split Virus Strain B |
Sanofi Winthrop Industrie |
Not marketed |
| Efluelda Tetra, suspension for injection in pre-filled syringe PA23458/012/001 |
Influenza Inactivated Split Virus Strain B, Influenza Inactivated Split Virus Strain A (H3N2), Influenza Inactivated Split Virus Strain B, Influenza Inactivated Split Virus Strain A (H1N1) |
Sanofi Winthrop Industrie |
Not marketed |
| Eklira Genuair 322 micrograms inhalation powder EU/1/12/778/001-003 |
Micronized aclidinium bromide |
Covis Pharma Europe B.V. |
— |
| Elymbus 0.1 mg/g eye gel in single-dose container PA1107/019/001 |
Bimatoprost |
Laboratoires Thea |
Marketed |
| EMLA 5% w/w Cream PA1691/023/001 |
Lidocaine, Prilocaine |
Aspen Pharma Trading Limited |
Marketed |
| Enerzair Breezhaler 114 micrograms/46 micrograms/136 micrograms inhalation powder, hard capsules EU/1/20/1438/001-005 |
Indacaterol acetate, Glycopyrronium bromide, Mometasone furoate |
Novartis Europharm Limited |
— |
| Enhertu 100 mg powder for concentrate for solution for infusion EU/1/20/1508/001 |
Trastuzumab Deruxtecan |
Daiichi Sankyo Europe GmbH |
— |
| Ervebo solution for injection EU/1/19/1392/001 |
Recombinant Vesicular Stomatitis Virus - Zaire Ebolavirus Vaccine (Live Attenuated) |
Merck Sharp & Dohme BV, |
— |
| Esomeprazole Tillomed 40 mg powder for solution for injection/infusion PA2321/002/001 |
Esomeprazole |
Laboratorios Tillomed Spain, S.L.U. |
Marketed |
| Espestesin 40 mg/ml + 5 microgram/ml solution for injection PA25244/001/002 |
Articaine hydrochloride, Epinephrine |
Pierrel S.p.A. |
Not marketed |
| Espestesin Forte 40 mg/ml + 10 microgram/ml solution for injection PA25244/001/001 |
Articaine hydrochloride, Epinephrine |
Pierrel S.p.A. |
Not marketed |
| EURneffy 1 mg nasal spray, solution in single-dose container EU/1/24/1846/003-004 |
Epinephrine |
ALK-Abello A/S |
— |
| EXPAREL liposomal EU/1/20/1489/001-004 |
Bupivacaine |
Pacira Ireland Limited |
— |
| Fixapost 50 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container PA1107/014/001 |
Timolol, Latanoprost |
Laboratoires Thea |
Marketed |
| Flecainide 100mg Tablets PA1986/050/002 |
Flecainide acetate |
Teva B.V. |
Marketed |
| Flecainide 50mg Tablets PA1986/050/001 |
Flecainide acetate |
Teva B.V. |
Marketed |
| Fluarix Tetra suspension for injection in pre-filled syringe Influenza vaccine (split virion, inactivated) PA1077/134/001 |
A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238, A/Darwin/9/2021 (H3N2)-like strain (A/Darwin/6/2021, IVR-227), B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, BVR-26) [Victoria lineage], B/PHUKET/3073/2013 -LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE) |
GlaxoSmithKline (Ireland) Limited |
Not marketed |
| Fluenz nasal spray suspension Influenza vaccine (live, nasal) EU/1/24/1816/001-002 |
REASSORTANT INFLUENZA VIRUS (LIVE ATTENUATED) B/<OFFICIAL STRAIN> LIKE STRAIN (<ACTUAL STRAIN>) 10^7.0±0.5 FLUORESCENT FOCUS UNITS PER 0.2 ML, REASSORTANT INFLUENZA VIRUS (LIVE ATTENUATED) A/<OFFICIAL STRAIN> (H3N2) LIKE STRAIN (<ACTUAL STRAIN>) 10^7.0±0.5 FLUORESCENT FOCUS UNITS PER 0.2 ML, REASSORTANT INFLUENZA VIRUS (LIVE ATTENUATED) A/<OFFICIAL STRAIN> (H1N1) LIKE STRAIN (<ACTUAL STRAIN>) 10^7.0±0.5 FLUORESCENT FOCUS UNITS PER 0.2 ML |
AstraZeneca AB |
— |
| Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution EU/1/13/381/001 |
Lidocaine, Prilocaine |
Recordati Ireland Limited |
— |
| Fostair 100 microgram/6 microgram per actuation pressurised inhalation solution PA0584/008/001 |
Beclometasone dipropionate, Formoterol fumarate dihydrate |
Chiesi Farmaceutici S.p.A. |
Not marketed |