| Divigel 0.1% w/w Gel, 1 mg/dose PPA23080/026/001 |
Estradiol |
Merit Pharmaceuticals Limited |
— |
| Dobutamine 12.5mg/ml Concentrate for Solution for Infusion PA0073/137/001 |
DOBUTAMINE HYDROCHLORIDE |
Mercury Pharmaceuticals (Ireland) Ltd |
Marketed |
| Dolenio 1500mg Film-coated tablets PA1516/001/001 |
Glucosamine sulfate |
Blue Bio Pharmaceuticals Ltd |
Marketed |
| Dosulepin Hydrochloride 25 mg Hard Capsules PA22871/013/001 |
Dosulepin hydrochloride |
Azure Pharmaceuticals Ltd. |
Not marketed |
| Dosulepin Hydrochloride Azure 75 mg Coated Tablets PA22871/025/001 |
Dosulepin hydrochloride |
Azure Pharmaceuticals Ltd. |
Not marketed |
| Doxycycline 100 mg hard capsules PA1418/010/002 |
Doxycycline hyclate |
Athlone Pharmaceuticals Limited |
Marketed |
| Doxycycline 100 mg hard capsules PA1567/006/002 |
Doxycycline hyclate |
Activase Pharmaceuticals Limited |
Not marketed |
| Doxycycline 50 mg hard capsules PA1418/010/001 |
Doxycycline hyclate |
Athlone Pharmaceuticals Limited |
Marketed |
| Doxycycline Bluefish 100 mg Capsules PA1436/030/001 |
Doxycycline |
Bluefish Pharmaceuticals AB |
Marketed |
| Dutasteride Rowa 0.5 mg soft capsules PA0074/076/002 |
Dutasteride |
Rowa Pharmaceuticals Limited, |
Marketed |
| Dutasteride/Tamsulosin Rowa 0.5 mg/0.4 mg hard capsules. PA0074/076/001 |
Tamsulosin hydrochloride, Dutasteride |
Rowa Pharmaceuticals Limited, |
Marketed |
| Dymista 137 micrograms/50 micrograms per actuation, Nasal Spray Suspension PPA23080/018/001 |
Fluticasone propionate, Azelastine hydrochloride |
Merit Pharmaceuticals Limited |
— |
| Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg film-coated tablets EU/1/17/1222/001-002 |
Efavirenz, Tenofovir disoproxil maleate, Emtricitabine |
Mylan Pharmaceuticals Limited |
— |
| Ekterly 300 mg film-coated tablets EU/1/25/1975/001-002 |
Sebetralstat |
Kalvista Pharmaceuticals (Ireland) Limited |
— |
| Elaprase 2 mg/ml concentrate for solution for infusion EU/1/06/365/1-3 |
Idursulfase |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets EU/1/16/1133/001-006 |
Emtricitabine, Tenofovir disoproxil |
Mylan Pharmaceuticals Limited |
— |
| Enrylaze 10 mg/0.5 mL solution for injection/infusion. EU/1/23/1747/001 |
Crisantaspase |
Jazz Pharmaceuticals Ireland Limited |
— |
| Epidyolex 100 mg/ml oral solution EU/1/19/1389/001 |
CANNABIDIOL |
Jazz Pharmaceuticals Ireland Limited |
— |
| Equasym XL 10 mg modified-release capsules, hard PA23211/001/001 |
Methylphenidate hydrochloride |
Takeda Pharmaceuticals International AG Ireland Branch |
Marketed |
| Equasym XL 20 mg modified-release capsules, hard PA23211/001/002 |
Methylphenidate hydrochloride |
Takeda Pharmaceuticals International AG Ireland Branch |
Marketed |
| Equasym XL 30 mg modified-release capsules, hard PA23211/001/003 |
Methylphenidate hydrochloride |
Takeda Pharmaceuticals International AG Ireland Branch |
Marketed |
| Equasym XL 40 mg modified-release capsules, hard PA23211/001/004 |
Methylphenidate hydrochloride |
Takeda Pharmaceuticals International AG Ireland Branch |
Not marketed |
| Equasym XL 50 mg modified-release capsules, hard PA23211/001/005 |
Methylphenidate hydrochloride |
Takeda Pharmaceuticals International AG Ireland Branch |
Not marketed |
| Equasym XL 60 mg modified-release capsules, hard PA23211/001/006 |
Methylphenidate hydrochloride |
Takeda Pharmaceuticals International AG Ireland Branch |
Not marketed |
| Escitalopram Bluefish 10 mg film-coated tablets PA1436/023/002 |
Escitalopram oxalate |
Bluefish Pharmaceuticals AB |
Marketed |
| Escitalopram Bluefish 15 mg film-coated tablets PA1436/023/003 |
Escitalopram oxalate |
Bluefish Pharmaceuticals AB |
Marketed |
| Escitalopram Bluefish 20 mg film-coated tablets PA1436/023/004 |
Escitalopram oxalate |
Bluefish Pharmaceuticals AB |
Marketed |
| Escitalopram Bluefish 5 mg film-coated tablets PA1436/023/001 |
Escitalopram oxalate |
Bluefish Pharmaceuticals AB |
Marketed |
| Esomeprazole Jubilant 20 mg gastro-resistant tablets PA1111/002/001 |
Esomeprazole magnesium (amorphous) |
Jubilant Pharmaceuticals nv |
Marketed |
| Esomeprazole Jubilant 40 mg gastro-resistant tablets PA1111/002/002 |
Esomeprazole magnesium (amorphous) |
Jubilant Pharmaceuticals nv |
Marketed |
| Estradot 100 micrograms/24 hours, transdermal patch PA23311/004/004 |
Estradiol |
Sandoz Pharmaceuticals d.d. |
Marketed |
| Estradot 25 micrograms/24 hours, transdermal patch PA23311/004/005 |
Estradiol |
Sandoz Pharmaceuticals d.d. |
Not marketed |
| Estradot 37.5 micrograms/24 hours, transdermal patch PA23311/004/001 |
Estradiol |
Sandoz Pharmaceuticals d.d. |
Marketed |
| Estradot 50 micrograms/24 hours, transdermal patch PA23311/004/002 |
Estradiol |
Sandoz Pharmaceuticals d.d. |
Marketed |
| Estradot 75 micrograms/24 hours, transdermal patch PA23311/004/003 |
Estradiol |
Sandoz Pharmaceuticals d.d. |
Marketed |
| Ezetimibe Rowa 10 mg tablets PA0074/074/001 |
Ezetimibe |
Rowa Pharmaceuticals Limited, |
Marketed |
| Fampridine Rowa 10 mg prolonged-release tablets PA0074/087/001 |
Fampridine |
Rowa Pharmaceuticals Limited |
Not marketed |
| Fampyra 10 mg prolonged-release tablets EU/1/11/699/001-002 |
Fampridine |
Merz Pharmaceuticals GmbH |
— |
| Febuxostat Rowa 120 mg film-coated tablets PA0074/085/002 |
Febuxostat |
Rowa Pharmaceuticals Limited, |
— |
| Febuxostat Rowa 80 mg film-coated tablets PA0074/085/001 |
Febuxostat |
Rowa Pharmaceuticals Limited, |
— |
| Fentanyl 100 micrograms in 2 ml Solution for Injection PA0073/122/001 |
FENTANYL CITRATE |
Mercury Pharmaceuticals (Ireland) Ltd |
Marketed |
| Fentanyl 500 micrograms in 10 ml Solution for Injection PA0073/122/002 |
FENTANYL CITRATE |
Mercury Pharmaceuticals (Ireland) Ltd |
Marketed |
| Fesoterodine Rowa 4 mg prolonged-release tablets PA0074/091/001 |
Fesoterodine fumarate |
Rowa Pharmaceuticals Limited, |
Not marketed |
| Fesoterodine Rowa 8 mg prolonged-release tablets PA0074/091/002 |
Fesoterodine fumarate |
Rowa Pharmaceuticals Limited, |
Not marketed |
| Fexo Allergy Relief 120 mg film-coated tablets PA0074/096/001 |
Fexofenadine hydrochloride |
Rowa Pharmaceuticals Limited, |
Marketed |
| Fexofenadine Hydrochloride 120 mg Film-coated tablets PA22871/004/002 |
Fexofenadine hydrochloride |
Azure Pharmaceuticals Ltd. |
Marketed |
| Fexofenadine Hydrochloride 180 mg Film-coated tablets PA22871/004/003 |
Fexofenadine hydrochloride |
Azure Pharmaceuticals Ltd. |
Marketed |
| Fingolimod 0.5 mg hard capsules PA0074/086/001 |
Fingolimod |
Rowa Pharmaceuticals Limited, |
Not marketed |
| Fingolimod Bluefish 0.5 mg hard capsules PA1436/035/001 |
FINGOLIMOD HYDROCHLORIDE |
Bluefish Pharmaceuticals AB |
Not marketed |
| Fingolimod Mylan 0.5 mg hard capsules EU/1/21/1573/001-024 |
FINGOLIMOD HYDROCHLORIDE |
Mylan Pharmaceuticals Limited |
— |