| Sandostatin LAR 20 mg powder and solvent for suspension for injection PA0896/028/005 |
Octreotide |
Novartis Ireland Limited |
Marketed |
| Sandostatin LAR 30 mg powder and solvent for suspension for injection PA0896/028/006 |
Octreotide |
Novartis Ireland Limited |
Marketed |
| Sativex oromucosal spray PA25377/001/001 |
Delta-9-tetrahydrocannabinol botanical drug substance (thc bds), CANNABIDIOL |
CNX Therapeutics Ireland Limited |
Marketed |
| Savene 20 mg/ml powder and solvent for concentrate for solution for infusion EU/1/06/350/001 |
Dexrazoxane |
CNX Therapeutics Ireland Limited |
— |
| Savlon Antiseptic Liquid PA0678/139/001 |
Chlorhexidine gluconate, Cetrimide |
Haleon Ireland Limited |
Not marketed |
| Selexipag Accord 1 000 microgram film-coated tablets PA2315/281/005 |
Selexipag |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Selexipag Accord 1 200 microgram film-coated tablets PA2315/281/006 |
Selexipag |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Selexipag Accord 1 400 microgram film-coated tablets PA2315/281/007 |
Selexipag |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Selexipag Accord 1 600 microgram film-coated tablets PA2315/281/008 |
Selexipag |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Selexipag Accord 200 microgram film-coated tablets PA2315/281/001 |
Selexipag |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Selexipag Accord 400 microgram film-coated tablets PA2315/281/002 |
Selexipag |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Selexipag Accord 600 microgram film-coated tablets PA2315/281/003 |
Selexipag |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Selexipag Accord 800 microgram film-coated tablets PA2315/281/004 |
Selexipag |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Semglee 100 units/ml solution for injection in pre-filled pen EU/1/18/1270/001-004 |
Insulin glargine |
Biosimilar Collaborations Ireland Limited |
— |
| Senokot 7.5 mg/5 ml Syrup PA0979/016/003 |
Sennosides |
Reckitt Benckiser Ireland Ltd |
Marketed |
| Senokot 7.5mg Tablets PA0979/016/002 |
Senna pods powdered |
Reckitt Benckiser Ireland Ltd |
Marketed |
| Seretide 100 Diskus 50 microgram/100 microgram/dose inhalation powder, pre-dispensed PA1077/046/001 |
SALMETEROL XINAFOATE, Fluticasone propionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Seretide 125 Evohaler 25 microgram/125 microgram/dose pressurised inhalation, suspension PA1077/046/005 |
Fluticasone propionate, Salmeterol |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Seretide 250 Diskus 50 microgram/250 microgram/dose inhalation powder, pre-dispensed PA1077/046/002 |
SALMETEROL XINAFOATE, Fluticasone propionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Seretide 250 Evohaler 25 microgram/250 microgram/dose pressurised inhalation, suspension PA1077/046/006 |
Fluticasone propionate, Salmeterol |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Seretide 50 Evohaler 25 microgram/50 microgram/dose pressurised inhalation, suspension PA1077/046/004 |
Fluticasone propionate, Salmeterol |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Seretide 500 Diskus 50 microgram/500 microgram/dose inhalation powder, pre-dispensed PA1077/046/003 |
SALMETEROL XINAFOATE, Fluticasone propionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Serevent Diskus, 50 micrograms per metered dose, inhalation powder, pre-dispensed PA1077/047/003 |
Salmeterol |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Serevent Evohaler 25 micrograms per actuation pressurised inhalation suspension PA1077/047/005 |
Salmeterol |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Seroxat 10 mg film-coated tablets PA1077/097/004 |
Paroxetine |
GlaxoSmithKline (Ireland) Limited |
Not marketed |
| Seroxat 20 mg film-coated tablets PA1077/097/002 |
Paroxetine |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Seroxat 30 mg film-coated tablets PA1077/097/003 |
Paroxetine |
GlaxoSmithKline (Ireland) Limited |
Not marketed |
| Sertraline 100 mg film-coated tablets PA2315/177/002 |
Sertraline |
Accord Healthcare Ireland Ltd. |
Marketed |
| Sertraline 50 mg film-coated tablets PA2315/177/001 |
Sertraline |
Accord Healthcare Ireland Ltd. |
Marketed |
| Sildenafil Accord 100 mg film-coated tablets PA2315/069/003 |
Sildenafil |
Accord Healthcare Ireland Ltd. |
Marketed |
| Sildenafil Accord 25 mg film-coated tablets PA2315/069/001 |
Sildenafil |
Accord Healthcare Ireland Ltd. |
Marketed |
| Sildenafil Accord 50 mg film-coated tablets PA2315/069/002 |
Sildenafil |
Accord Healthcare Ireland Ltd. |
Marketed |
| Sildenvia 50 mg film-coated tablets PA2315/261/001 |
Sildenafil |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Silodosin Recordati 4 mg hard capsules EU/1/18/1343/001-006 |
Silodosin |
Recordati Ireland Limited |
— |
| Silodosin Recordati 8 mg hard capsules EU/1/18/1343/007-012 |
Silodosin |
Recordati Ireland Limited |
— |
| Silodyx 4 mg hard capsules EU/1/09/607/1-7 |
Silodosin |
Recordati Ireland Limited |
— |
| Silodyx 8 mg hard capsules EU/1/09/607/8-14 |
Silodosin |
Recordati Ireland Limited |
— |
| Sinemet 10 mg/100 mg tablets PA23198/004/002 |
Carbidopa, Levodopa |
Organon Pharma (Ireland) Limited |
Marketed |
| Sinemet 12.5 mg/50 mg tablets PA23198/004/001 |
Carbidopa, Levodopa |
Organon Pharma (Ireland) Limited |
Marketed |
| Sinemet 25 mg/250 mg tablets PA23198/004/004 |
Levodopa, Carbidopa |
Organon Pharma (Ireland) Limited |
Marketed |
| Sinemet CR 50mg/200 mg Prolonged-release Tablets PA23198/004/005 |
Levodopa, Carbidopa |
Organon Pharma (Ireland) Limited |
Marketed |
| Sinemet Plus 25 mg/100 mg tablets PA23198/004/003 |
Levodopa, Carbidopa |
Organon Pharma (Ireland) Limited |
Marketed |
| Singulair 10 mg film-coated tablets PA23198/014/004 |
Montelukast sodium |
Organon Pharma (Ireland) Limited |
Marketed |
| 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 |
| Sitagliptin Metformin hydrochloride Mylan 50 mg/1000 mg film-coated tablets EU/1/21/1619/009-020 |
Metformin Hydrochloride, Sitagliptin |
Mylan Ireland Limited |
— |
| Solferol 1,000 IU Soft Capsules PA23126/001/003 |
Colecalciferol |
Windzor Pharma Ireland Limited |
Marketed |
| Solferol 10,000 IU Soft Capsules PA23126/001/004 |
Colecalciferol |
Windzor Pharma Ireland Limited |
Not marketed |
| Solferol 20,000 IU Soft Capsules PA23126/002/001 |
Colecalciferol |
Windzor Pharma Ireland Limited |
Marketed |
| Solferol 400 IU Soft Capsules PA23126/001/001 |
Colecalciferol |
Windzor Pharma Ireland Limited |
Marketed |