| Spiriva 18 microgram inhalation powder, hard capsule PPA23080/007/001 |
Tiotropium bromide |
Merit Pharmaceuticals Limited |
— |
| Stalpex 50 microgram/500 microgram/dose inhalation powder, pre-dispensed PA22815/001/001 |
Salmeterol, Fluticasone propionate |
Glenmark Pharmaceuticals Nordic AB |
— |
| Sterile Dopamine Concentrate BP 160mg/ml, 5ml PA0073/108/002 |
DOPAMINE HYDROCHLORIDE |
Mercury Pharmaceuticals (Ireland) Ltd |
Not marketed |
| Sterile Dopamine Concentrate BP 40mg/ml PA0073/108/001 |
DOPAMINE HYDROCHLORIDE |
Mercury Pharmaceuticals (Ireland) Ltd |
Not marketed |
| Sugammadex Mylan 100 mg/mL solution for injection EU/1/21/1583/001-004 |
Sugammadex sodium |
Mylan Pharmaceuticals Limited |
— |
| Sugammadex – Amomed® EU/1/22/1708/001 |
Sugammadex sodium |
Aop Orphan Pharmaceuticals GmbH |
— |
| Sunitinib Bluefish 12.5 mg hard capsules PA1436/041/001 |
Sunitinib |
Bluefish Pharmaceuticals AB |
Not marketed |
| Sunitinib Bluefish 25 mg hard capsules PA1436/041/002 |
Sunitinib |
Bluefish Pharmaceuticals AB |
Not marketed |
| Sunitinib Bluefish 50 mg hard capsules PA1436/041/003 |
Sunitinib |
Bluefish Pharmaceuticals AB |
Not marketed |
| Suxamethonium Chloride 50mg/ml Solution for Injection PA0073/110/001 |
Suxamethonium chloride |
Mercury Pharmaceuticals (Ireland) Ltd |
Not marketed |
| Symbicort Turbohaler 200 micrograms/6 micrograms/inhalation, inhalation powder PPA23080/021/001 |
Budesonide, Formoterol fumarate dihydrate |
Merit Pharmaceuticals Limited |
— |
| Symbicort Turbohaler 400 micrograms/12 micrograms/inhalation, inhalation powder PPA23080/021/002 |
Budesonide dihydrate, Formoterol fumarate dihydrate |
Merit Pharmaceuticals Limited |
— |
| Symkevi 100 mg/150 mg Film-coated tablet EU/1/18/1306/001 |
TEZACAFTOR, Ivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Symkevi 50 mg/75 mg Film-coated tablet EU/1/18/1306/002 |
TEZACAFTOR, Ivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Tadalafil 20 mg film-coated tablets PA22865/012/002 |
Tadalafil |
Renata Pharmaceuticals (Ireland) Limited |
Not marketed |
| Tadalafil 5 mg film-coated tablets PA22865/012/001 |
Tadalafil |
Renata Pharmaceuticals (Ireland) Limited |
Not marketed |
| Tadalafil Mylan 10 mg film-coated tablets EU/1/14/961/001 |
Tadalafil |
Mylan Pharmaceuticals Limited |
— |
| Tadalafil Mylan 2.5 mg film-coated tablets EU/1/14/961/008-009 |
Tadalafil |
Mylan Pharmaceuticals Limited |
— |
| Tadalafil Mylan 20 mg film-coated tablets EU/1/14/961/002-006 |
Tadalafil |
Mylan Pharmaceuticals Limited |
— |
| Tadalafil Mylan 5 mg film-coated tablets EU/1/14/961/012-017 |
Tadalafil |
Mylan Pharmaceuticals Limited |
— |
| TAKHZYRO 150 mg solution for injection in pre-filled syringe EU/1/18/1340/007-009 |
LANADELUMAB |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| TAKHZYRO 300 mg solution for injection EU/1/18/1340/001 |
LANADELUMAB |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Tamsulosin Rowa 400 microgram modified-release hard capsules PA0074/101/001 |
Tamsulosin hydrochloride |
Rowa Pharmaceuticals Limited, |
Not marketed |
| Targin 10mg/5mg prolonged-release tablets PA1688/010/002 |
OXYCODONE HYDROCHLORIDE, Naloxone hydrochloride dihydrate |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Targin 15 mg/7.5 mg prolonged-release tablets PA1688/010/006 |
OXYCODONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Targin 20mg/10mg prolonged-release tablets PA1688/010/003 |
OXYCODONE HYDROCHLORIDE, Naloxone hydrochloride dihydrate |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Targin 30 mg/15 mg prolonged-release tablets PA1688/010/007 |
OXYCODONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Targin 40 mg/20 mg prolonged-release tablets PA1688/010/004 |
OXYCODONE HYDROCHLORIDE, Naloxone hydrochloride dihydrate |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Targin 5 mg/2.5 mg prolonged-release tablets PA1688/010/001 |
OXYCODONE HYDROCHLORIDE, Naloxone hydrochloride dihydrate |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Tavlesse EU/1/19/1408/001 |
FOSTAMATINIB |
Rigel Pharmaceuticals B.V. |
— |
| Telmisartan Rowa 20 mg tablets PA0074/078/001 |
Telmisartan |
Rowa Pharmaceuticals Limited, |
Marketed |
| Telmisartan Rowa 40 mg tablets PA0074/078/002 |
Telmisartan |
Rowa Pharmaceuticals Limited, |
Marketed |
| Telmisartan Rowa 80 mg tablets PA0074/078/003 |
Telmisartan |
Rowa Pharmaceuticals Limited, |
Marketed |
| Telmisartan/Hydrochlorothiazide Rowa 40 mg/12.5 mg tablets PA0074/081/001 |
Telmisartan, Hydrochlorothiazide |
Rowa Pharmaceuticals Limited, |
Marketed |
| Telmisartan/Hydrochlorothiazide Rowa 80 mg/12.5 mg tablets PA0074/081/002 |
Telmisartan, Hydrochlorothiazide |
Rowa Pharmaceuticals Limited, |
Marketed |
| Telmisartan/Hydrochlorothiazide Rowa 80 mg/25 mg tablets PA0074/081/003 |
Telmisartan, Hydrochlorothiazide |
Rowa Pharmaceuticals Limited, |
Marketed |
| Temgesic 200 microgram Sublingual Tablets PA23460/001/001 |
Buprenorphine hydrochloride |
Eumedica Pharmaceuticals GmbH |
Not marketed |
| Temgesic 300 micrograms/ml, solution for injection PA23460/001/002 |
Buprenorphine hydrochloride |
Eumedica Pharmaceuticals GmbH |
Not marketed |
| Terbinafine Rowa 250 mg tablets PA0074/084/001 |
Terbinafine |
Rowa Pharmaceuticals Limited |
Marketed |
| Teriflunomide Viatris 14 mg film-coated tablets EU/1/22/1698/001-007 |
Teriflunomide |
Mylan Pharmaceuticals Limited |
— |
| Testogel 50 mg transdermal gel in sachet PPA23080/032/001 |
Testosterone |
Merit Pharmaceuticals Limited |
— |
| Thalidomide BMS 50 mg hard capsules EU/1/08/443/1 |
Thalidomide |
Bristol-Myers Squibb Pharmaceuticals uc |
— |
| Thiotepa Riemser 100 mg powder for concentrate for solution for infusion EU/1/21/1536/002 |
Thiotepa |
Esteve Pharmaceuticals GmbH |
— |
| Thiotepa Riemser 15 mg powder for concentrate for solution for infusion EU/1/21/1536/001 |
Thiotepa |
Esteve Pharmaceuticals GmbH |
— |
| Ticagrelor Bluefish 60 mg film-coated tablets PA1436/049/001 |
Ticagrelor |
Bluefish Pharmaceuticals AB |
Not marketed |
| Ticagrelor Bluefish 90 mg film-coated tablets PA1436/049/002 |
Ticagrelor |
Bluefish Pharmaceuticals AB |
Not marketed |
| Tiogiva, 18 microgram, inhalation powder, hard capsule PA22815/002/001 |
Tiotropium bromide |
Glenmark Pharmaceuticals Nordic AB |
Not marketed |
| Topamax 100 mg film-coated tablets PPA23080/016/003 |
Topiramate |
Merit Pharmaceuticals Limited |
— |
| Topamax 25 mg film-coated tablets PPA23080/016/001 |
Topiramate |
Merit Pharmaceuticals Limited |
— |
| Topamax 50 mg film-coated tablets PPA23080/016/002 |
Topiramate |
Merit Pharmaceuticals Limited |
— |