| 1% w/v Lidocaine Hydrochloride Injection BP PA0736/044/001 |
Lidocaine Hydrochloride Monohydrate |
B. Braun Melsungen AG |
Marketed |
| 2% w/v Lidocaine Hydrochloride Injection BP PA0736/044/002 |
Lidocaine Hydrochloride Monohydrate |
B. Braun Melsungen AG |
Marketed |
| Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection EU/1/13/882/001,003 |
Aripiprazole |
Otsuka Pharmaceutical Netherlands B.V. |
— |
| Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection EU/1/13/882/002,004 |
Aripiprazole |
Otsuka Pharmaceutical Netherlands B.V. |
— |
| Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe EU/1/13/882/009 |
Aripiprazole Monohydrate |
Otsuka Pharmaceutical Netherlands B.V. |
— |
| Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe EU/1/13/882/010 |
Aripiprazole Monohydrate |
Otsuka Pharmaceutical Netherlands B.V. |
— |
| ACTAIR 100 IR & 300 IR sublingual tablets PA2113/002/002 |
Dermatophagoides Pteronyssinus Extract, Dermatophagoides Farinae Extract |
Stallergenes |
Marketed |
| ACTAIR 100 IR sublingual tablets PA2113/002/001 |
Dermatophagoides Pteronyssinus Extract, Dermatophagoides Farinae Extract |
Stallergenes |
Marketed |
| ACTAIR 300 IR sublingual tablets PA2113/002/003 |
Dermatophagoides Pteronyssinus Extract, Dermatophagoides Farinae Extract |
Stallergenes |
Marketed |
| Aimovig 140 mg Solution for injection EU/1/18/1293/004-006 |
ERENUMAB |
Novartis Pharma GmbH |
— |
| Aimovig 70 mg Solution for injection EU/1/18/1293/001-003 |
ERENUMAB |
Novartis Europharm Limited |
— |
| AirBuFo Forspiro 160 microgram/4.5 microgram/dose inhalation powder, pre-dispensed PA0711/284/001 |
Budesonide, Formoterol fumarate dihydrate |
Rowex Limited, |
Marketed |
| AirBuFo Forspiro 320 microgram/9 microgram/dose inhalation powder, pre-dispensed PA0711/284/002 |
Budesonide, Formoterol fumarate dihydrate |
Rowex Limited, |
Marketed |
| AirFluSal Forspiro 50 microgram/250 microgram/dose, inhalation powder, predispensed PA0711/237/001 |
Salmeterol, Fluticasone propionate |
Rowex Ltd |
Marketed |
| AirFluSal Forspiro 50 microgram/500 microgram/dose, inhalation powder, predispensed PA0711/237/002 |
Salmeterol, Fluticasone propionate |
Rowex Ltd |
Marketed |
| AirFluSal MDI 25 microgram/125 microgram/dose pressurised inhalation, suspension PA0711/270/001 |
SALMETEROL XINAFOATE, Fluticasone propionate |
Rowex Limited, |
Not marketed |
| AirFluSal MDI 25 microgram/250 microgram/dose pressurised inhalation, suspension PA0711/270/002 |
Salmeterol, Fluticasone propionate |
Rowex Limited, |
Not marketed |
| AKANTIOR 0.8 mg/mL eye drops, solution in single-dose container EU/1/24/1840/001-003 |
Polihexanide |
SIFI S.p.A. |
— |
| Albunorm 20%, 200g/l, solution for infusion PA2219/007/002 |
Human plasma protein not containing less than 96% human albumin |
Octapharma (IP) |
Marketed |
| Albunorm 5%, 50 g/l, solution for infusion PA2219/007/001 |
Human plasma protein not containing less than 96% human albumin |
Octapharma (IP) |
Marketed |
| Ametop 40 mg/g Gel PA2325/002/001 |
Tetracaine base |
Alliance Pharma (Ireland) Limited |
Marketed |
| Amorolfine 5 % w/v medicated nail lacquer PA0711/309/001 |
Amorolfine hydrochloride |
Rowex Ltd |
Marketed |
| Amorolfine 5% w/v medicated nail lacquer PA1436/029/001 |
Amorolfine |
Bluefish Pharmaceuticals AB |
Marketed |
| Ampres 10mg/ml solution for injection PA0736/043/001 |
Chloroprocaine hydrochloride |
B. Braun Melsungen AG |
Marketed |
| Ampres 20 mg/ml solution for injection PA0736/043/002 |
Chloroprocaine hydrochloride |
B. Braun Melsungen AG |
Not marketed |
| Amversio 1 g oral powder EU/1/22/1640/001 |
Betaine anhydrous |
SERB S.A. |
— |
| Anbesol Anaesthetic Antiseptic Oromucosal Solution PA2325/003/001 |
Lidocaine hydrochloride, Chlorocresol, Cetylpyridinium chloride |
Alliance Pharma (Ireland) Limited |
Marketed |
| Atorvastatin OPKO 40 mg film coated tablets PA23271/001/001 |
Atorvastatin calcium trihydrate |
Opko Health Spain S.L.U. |
Not marketed |
| Axsain 0.075% w/w Cream PA23369/004/001 |
Capsaicin |
Ennogen Healthcare (Europe) Limited |
Marketed |
| Azyter 15 mg/g eye drops, solution, in single-dose container PA1107/004/001 |
Azithromycin dihydrate |
Laboratoires Thea |
Marketed |
| Baiama 40 mg/mL solution for injection in a vial EU/1/24/1887/001 |
Aflibercept |
Formycon AG |
— |
| Baqsimi 3 mg nasal powder in single-dose container EU/1/19/1406/001-002 |
GLUCAGON |
Amphastar France Pharmaceuticals, S.A.S. |
— |
| Benylin Children’s Chesty Cough 50 mg/5 ml Syrup PA23490/011/001 |
Guaifenesin |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Benylin Mucus Cough Honey & Lemon 100mg/5ml Syrup PA23490/041/001 |
Guaifenesin |
JNTL Consumer Health I (Ireland) Limited |
Marketed |
| Benylin Mucus Cough Menthol 100 mg/5 ml oral solution PA23490/040/001 |
Guaifenesin |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Benylin Mucus Cough Syrup Guaifenesin 100 mg/5 ml Levomenthol 1.1 mg/5 ml PA23490/031/001 |
Levomenthol, Guaifenesin |
JNTL Consumer Health I (Ireland) Limited |
Marketed |
| Benylin Non-drowsy for Chesty Coughs Syrup Guaifenesin 100 mg/5 ml Levomenthol 1.1 mg/5 ml PA23490/007/001 |
Levomenthol, Guaifenesin |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Benylin Phlegm Cough plus Decongestant SyrupGuaifenesin 100 mg/5 mlPseudoephedrine Hydrochloride 30 mg/5 ml PA23490/015/001 |
PSEUDOEPHEDRINE HYDROCHLORIDE, Guaifenesin |
JNTL Consumer Health I (Ireland) Limited |
Not marketed |
| Bepantiseptic First Aid Cream PA1410/047/001 |
Phenol, Chlorhexidine digluconate |
Bayer Limited |
Marketed |
| Bicalutamide Fair-Med 150mg Film-coated Tablets PA1789/001/002 |
Bicalutamide |
Fairmed Healthcare GmbH |
Not marketed |
| Bicalutamide Fair-Med 50 mg film-coated tablets PA1789/001/001 |
Bicalutamide |
Fairmed Healthcare GmbH |
Not marketed |
| BIMERVAX emulsion for injection COVID-19 Vaccine (recombinant, adjuvanted) EU/1/22/1709/001-004 |
SARS-CoV-2 virus, variants B.1.351-B.1.1.7, spike protein, receptor binding domain fusion heterodimer |
Hipra Human Health S.L. |
— |
| BIMERVAX XBB.1.16. COVID-19 Vaccine (recombinant, adjuvanted) EU/1/22/1709/005-007 |
SARS-CoV-2, variant XBB.1.16, spike protein, receptor binding domain fusion homodimer |
Hipra Human Health S.L. |
— |
| Bretaris Genuair 322 micrograms inhalation powder EU/1/12/781/001-003 |
Micronized aclidinium bromide |
Covis Pharma Europe B.V. |
— |
| Brimica Genuair 340 micrograms /12 micrograms inhalation powder EU/1/14/963/001-003 |
Micronized formoterol fumarate dihydrate, Micronized aclidinium bromide |
Covis Pharma Europe B.V. |
— |
| Bronx Airmaster 50 microgram/100 microgram/ dose inhalation powder, pre-dispensed PA23030/001/001 |
Salmeterol, Fluticasone propionate |
Neutec Inhaler Ireland Limited |
— |
| Bronx Airmaster 50 microgram/250 microgram/ dose inhalation powder, pre-dispensed PA23030/001/002 |
Salmeterol, Fluticasone propionate |
Neutec Inhaler Ireland Limited |
— |
| Bronx Airmaster 50 microgram/500 microgram/ dose inhalation powder, pre-dispensed PA23030/001/003 |
Salmeterol, Fluticasone propionate |
Neutec Inhaler Ireland Limited |
— |
| Bupivacaine 2.5 mg/ml Solution for Injection PA2299/035/001 |
Bupivacaine hydrochloride, monohydrate |
Baxter Holding B.V. |
Not marketed |
| Bupivacaine 2.5 mg/ml Solution for injection PA1122/029/001 |
Bupivacaine hydrochloride, anhydrous |
Noridem Enterprises Limited |
Not marketed |