| Ropivacaine Readyfusor 10 mg/h solution for infusion in administration system PA2284/001/001 |
Ropivacaine hydrochloride monohydrate |
BioQ Pharma B.V. |
— |
| Saflutan 15 micrograms/ml, eye drops, solution in single-dose container PA0879/006/001 |
Tafluprost |
Santen OY |
Marketed |
| Saflutan 15 micrograms/ml, eye drops, solution in single-dose container PPA0465/324/001 |
Tafluprost |
PCO Manufacturing Ltd. |
— |
| Saizen 5.83 mg/ml solution for injection in cartridge PA2286/006/001 |
Somatropin |
Merck Serono (Ireland) Limited |
Marketed |
| Saizen 8 mg/ml solution for injection in cartridge PA2286/006/002 |
Somatropin |
Merck Serono (Ireland) Limited |
Marketed |
| Saizen 8 mg/ml solution for injection in cartridge PPA0465/506/001 |
Somatropin |
PCO Manufacturing Ltd. |
— |
| Sametec Airmaster 50 microgram/ 100 microgram/ dose, inhalation powder, pre-dispensed PA0126/342/001 |
SALMETEROL XINAFOATE, Fluticasone propionate |
Clonmel Healthcare Ltd |
Marketed |
| Sametec Airmaster 50 microgram/ 250 microgram/ dose, inhalation powder, pre-dispensed PA0126/342/002 |
SALMETEROL XINAFOATE, Fluticasone propionate |
Clonmel Healthcare Ltd |
Marketed |
| Sametec Airmaster 50 microgram/ 500 microgram/ dose, inhalation powder, pre-dispensed PA0126/342/003 |
SALMETEROL XINAFOATE, Fluticasone propionate |
Clonmel Healthcare Ltd |
Marketed |
| Scandonest 3% w/v Solution for Injection PA0196/015/001 |
Mepivacaine hydrochloride |
Septodont |
Marketed |
| Scheriproct 1 mg + 1 mg suppositories PA22650/005/002 |
Prednisolone, Cinchocaine Hydrochloride |
Karo Pharma AB |
Marketed |
| Scheriproct 1.5 mg/g + 5 mg/g rectal ointment PA22650/005/001 |
Prednisolone caproate, Cinchocaine Hydrochloride |
Karo Pharma AB |
Marketed |
| Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder EU/1/21/1533/001-002 |
SALMETEROL XINAFOATE, Fluticasone propionate |
Teva B.V. |
— |
| Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder EU/1/21/1533/003-004 |
SALMETEROL XINAFOATE, Fluticasone propionate |
Teva B.V. |
— |
| Septanest 40 mg/ml + 10 micrograms/ml, solution for injection PA0196/017/002 |
Articaine hydrochloride, Adrenaline tartrate |
Septodont |
Marketed |
| 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., |
— |
| Skinoren 15% Gel PA1025/009/001 |
Azelaic acid |
LEO Pharma A/S |
Marketed |
| SmofKabiven Central emulsion for infusion PA2059/058/002 |
Soya bean oil, refined, Medium chain triglycerides, Refined soyabean oil, Fish oil, rich in omega-3 acids, L-alanine |
Fresenius Kabi Deutschland GmbH |
Marketed |
| SmofKabiven Peripheral, emulsion for infusion PA2059/061/002 |
SOYA BEAN OIL, REFINED PH. EUR., Medium chain triglycerides, Refined olive oil, Fish oil, rich in omega-3 acids, Isoleucine |
Fresenius Kabi Deutschland GmbH |
Marketed |
| SMOFlipid 200 mg/ml emulsion for infusion, excel bag PA2059/062/002 |
Soya bean oil, Medium chain triglycerides, Refined olive oil, Fish oil, rich in omega-3 acids |
Fresenius Kabi Deutschland GmbH |
Marketed |
| SMOFlipid 200 mg/ml emulsion for infusion, glass bottle PA2059/062/001 |
Soybean oil, Triglycerides, medium chain, Refined olive oil, Fish oil, rich in omega-3 acids |
Fresenius Kabi Deutschland GmbH |
Marketed |
| Sodium Chloride 0.18% w/v and Glucose 4.0% w/v Intravenous Infusion BP, (Viaflo Container) PA2299/008/005 |
Sodium chloride, Anhydrous glucose |
Baxter Holding B.V. |
Marketed |
| Sodium Chloride 0.9% w/v and Glucose 5% w/v Solution for Infusion BP (Viaflo container) PA2299/008/002 |
Sodium chloride, Glucose |
Baxter Holding B.V. |
Marketed |
| Sodium Chloride Intravenous Infusion BP 0.9% w/v (viaflex container) PA2299/002/003 |
Sodium chloride |
Baxter Holding B.V. |
Marketed |
| Solpa Cold & Flu Multi-Relief Capsules Paracetamol 500mg,Guaifenesin 100mg,Phenylephrine hydrochloride 6.1mg PA1186/021/002 |
Phenylephrine hydrochloride, Guaifenesin, Paracetamol |
Chefaro Ireland DAC |
Marketed |
| Solpa Cold & Flu Multi-Relief Max Powder for Oral Solution Paracetamol 1000 mg, Guaifenesin 200 mg, Phenylephrine hydrochloride 12.2 mg PA1186/021/003 |
Paracetamol, Guaifenesin, Phenylephrine hydrochloride |
Chefaro Ireland DAC, |
Marketed |
| Spikevax 0.1 mg/mL dispersion for injection EU/1/20/1507/002 |
Elasomeran |
Moderna Biotech Spain S.L. |
— |
| Spikevax 0.2 mg/mL dispersion for injection EU/1/20/1507/001 |
mRNA-1273 |
MODERNA BIOTECH SPAIN, S.L (Non-Current) |
— |
| Spikevax 50 micrograms dispersion for injection in pre-filled syringe EU/1/20/1507/003 |
Elasomeran |
Moderna Biotech Spain S.L. |
— |
| Spikevax bivalent Original/Omicron BA.1 EU/1/20/1507/004-005 |
Elasomeran |
Moderna Biotech Spain S.L. |
— |
| Spikevax bivalent Original/Omicron BA.1 EU/1/20/1507/007-008 |
Elasomeran |
Moderna Biotech Spain S.L. |
— |
| Spikevax bivalent Original/Omicron BA4-5 EU/1/20/1507/006 |
Elasomeran |
Moderna Biotech Spain S.L. |
— |
| Spikevax XBB.1.5 25 micrograms dispersion for injection in pre-filled syringe. COVID-19 mRNA Vaccine EU/1/20/1507/027-030 |
Andusomeran |
Moderna Biotech Spain S.L. |
— |
| STAMARIL, powder and solvent for suspension for injection in pre-filled syringe. Yellow fever vaccine (Live) PA23458/006/001 |
Yellow fever virus 17 d-204 strain |
Sanofi Winthrop Industrie |
Marketed |
| Strepsils +Plus Anaesthetic Lozenges Amylmetacresol 0.6mg 2,4-Dichlorobenzyl Alcohol 1.2mg Lidocaine Hydrochloride 10mg PA0979/040/001 |
Amylmetacresol, 2, 4-dichlorobenzyl alcohol, Lidocaine hydrochloride |
Reckitt Benckiser Ireland Ltd |
Marketed |
| Strepsils +Plus Anaesthetic Throat Spray Amylmetacresol 0.29mg/spray 2,4-Dichlorobenzyl Alcohol 0.58mg/spray Lidocaine 0.78mg/spray PA0979/040/002 |
Amylmetacresol, 2,4-Dichlorobenzyl alcohol, Lidocaine |
Reckitt Benckiser Ireland Ltd |
Marketed |
| Tambocor 10 mg/ml Solution for Injection or Infusion PA23355/023/001 |
Flecainide acetate |
Viatris Healthcare Limited |
Marketed |
| Tambocor 100 mg Tablets PA23355/023/003 |
Flecainide acetate |
Viatris Healthcare Limited |
Marketed |
| Tambocor 50 mg Tablets PA23355/023/002 |
Flecainide acetate |
Viatris Healthcare Limited |
Marketed |
| Taptiqom 15 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container PA0879/003/001 |
Tafluprost, Timolol |
Santen OY |
Marketed |
| Taptiqom 15 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container PPA0465/475/001 |
Tafluprost, Timolol |
PCO Manufacturing Ltd. |
— |
| Telmisartan Fair-Med 20 mg Tablets PA1789/008/001 |
Telmisartan |
Fairmed Healthcare GmbH |
Not marketed |
| Telmisartan Fair-Med 40 mg Tablets PA1789/008/002 |
Telmisartan |
Fairmed Healthcare GmbH |
Not marketed |
| Telmisartan Fair-Med 80 mg Tablets PA1789/008/003 |
Telmisartan |
Fairmed Healthcare GmbH |
Not marketed |