| Abseamed 20 000 IU/0.5 mL solution for injection in a pre-filled syringe EU/1/07/412/021-22 |
Epoetin alfa |
Medice Arzneimittel Putter GmbH & Co. K.G |
— |
| Abseamed 3 000 IU/0.3 mL solution for injection in a pre-filled syringe EU/1/07/412/5-6 |
Recombinant human erythropoietin alfa |
Medice Arzneimittel Putter GmbH & Co. K.G |
— |
| Abseamed 30 000 IU/0.75 mL solution for injection in a pre-filled syringe EU/1/07/412/023-24 |
Epoetin alfa |
Medice Arzneimittel Putter GmbH & Co. K.G |
— |
| Abseamed 4 000 IU/0.4 mL solution for injection in a pre-filled syringe EU/1/07/412/7-8 |
Recombinant human erythropoietin alfa |
Medice Arzneimittel Putter GmbH & Co. K.G |
— |
| Abseamed 40 000 IU/1 mL solution for injection in a pre-filled syringe EU/1/07/412/025-26 |
Epoetin alfa |
Medice Arzneimittel Putter GmbH & Co. K.G |
— |
| Abseamed 5 000 IU/0.5 mL solution for injection in a pre-filled syringe EU/1/07/412/9-10 |
Recombinant human erythropoietin alfa |
Medice Arzneimittel Putter GmbH & Co. K.G |
— |
| Abseamed 6 000 IU/0.6 mL solution for injection in a pre-filled syringe EU/1/07/412/11-12 |
Recombinant human erythropoietin alfa |
Medice Arzneimittel Putter GmbH & Co. K.G |
— |
| Abseamed 8 000 IU/0.8 mL solution for injection in a pre-filled syringe EU/1/07/412/13-14 |
Recombinant human erythropoietin alfa |
Medice Arzneimittel Putter GmbH & Co. K.G |
— |
| Abstral 100 microgram sublingual tablets PA2242/019/001 |
Fentanyl |
Grunenthal Pharma Limited. |
Marketed |
| Abstral 200 microgram sublingual tablets PA2242/019/002 |
Fentanyl |
Grunenthal Pharma Limited. |
Marketed |
| Abstral 300 microgram sublingual tablets PA2242/019/003 |
Fentanyl |
Grunenthal Pharma Limited. |
Marketed |
| Abstral 400 microgram sublingual tablets PA2242/019/004 |
Fentanyl |
Grunenthal Pharma Limited. |
Marketed |
| Abstral 600 microgram sublingual tablets PA2242/019/005 |
Fentanyl |
Grunenthal Pharma Limited. |
Marketed |
| Abstral 800 microgram sublingual tablets PA2242/019/006 |
Fentanyl |
Grunenthal Pharma Limited. |
Marketed |
| ACARIZAX 12 SQ-HDM sublingual lyophilisate PA1255/010/001 |
Dermatophagoides Farinae Extract, Dermatophagoides Pteronyssinus Extract |
ALK-Abello A/S |
Marketed |
| Accofil 30 MU/0.5 ml solution for injection/infusion in pre-filled syringe EU/1/14/946/001-002 |
Filgrastim |
Accord Healthcare S.L.U. |
— |
| Accofil 48 MU/0.5 ml solution for injection/infusion in pre-filled syringe EU/1/14/943/003-004 |
Filgrastim |
Accord Healthcare S.L.U. |
— |
| Accusol 35 Potassium 2 mmol/lSolution for haemofiltration, haemodialysis and haemodiafiltration PA2021/002/001 |
Sodium chloride, Calcium chloride, Magnesium chloride, Sodium bicarbonate, Potassium chloride |
Nikkiso Belgium bvba |
Marketed |
| Accusol 35 Potassium 4 mmol/lSolution for haemofiltration, haemodialysis and haemodiafiltration PA2021/002/002 |
Sodium chloride, Calcium chloride, Magnesium chloride, Sodium bicarbonate, Potassium chloride |
Nikkiso Belgium bvba |
Marketed |
| Accusol 35 Solution for haemofiltration, haemodialysis and haemodiafiltration PA2021/001/001 |
Sodium chloride, Calcium chloride, Magnesium chloride, Sodium bicarbonate |
Nikkiso Belgium bvba |
Marketed |
| Acerycal 10mg/10mg tablets PA0568/018/004 |
Perindopril arginine, Amlodipine besilate |
Les Laboratoires Servier |
Marketed |
| Acerycal 5mg/10mg tablets PA0568/018/002 |
Perindopril arginine, Amlodipine besilate |
Les Laboratoires Servier |
Marketed |
| Acerycal 10mg/5mg tablets PA0568/018/003 |
Perindopril arginine, Amlodipine besilate |
Les Laboratoires Servier |
Marketed |
| Acerycal 5mg/5mg tablets PA0568/018/001 |
Perindopril arginine, Amlodipine besilate |
Les Laboratoires Servier |
Marketed |
| Acetylcysteine Essential-Healthcare 600 mg effervescent tablets PA23163/003/001 |
Acetylcysteine |
Ascot Laboratories (Ireland) Limited |
Not marketed |
| Acic 5% Cream PA0711/017/001 |
Aciclovir |
Rowex Ltd |
Not marketed |
| Acic Cold Sore 5% w/w Cream PA0711/017/006 |
Aciclovir |
Rowex Ltd |
Marketed |
| Aciclovir 200 mg/5ml Oral Suspension PA22697/001/001 |
Aciclovir |
Syri Pharma Limited t/a Thame Laboratories |
Marketed |
| Aciclovir 250 mg powder for solution for infusion PA1122/043/001 |
Aciclovir |
Noridem Enterprises Limited |
Not marketed |
| Aciclovir 25mg/ml concentrate for solution for infusion PA0822/215/001 |
Aciclovir |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Aciclovir 25mg/ml Concentrate for solution for infusion PA2299/041/001 |
Aciclovir |
Baxter Holding B.V. |
Not marketed |
| Aciclovir 400 mg/5ml Oral Suspension PA22697/001/002 |
Aciclovir |
Syri Pharma Limited t/a Thame Laboratories |
Not marketed |
| Aciclovir 500 mg powder for solution for infusion PA1122/043/002 |
Aciclovir |
Noridem Enterprises Limited |
Not marketed |
| Aciclovir Agepha 30 mg/g eye ointment PA22584/001/001 |
Aciclovir |
AGEPHA Pharma s.r.o. |
Marketed |
| Aciclovir Azevedos 250 mg Powder for solution for infusion PA1852/003/001 |
Aciclovir |
Laboratórios Azevedos - Indústria Farmacêutica S.A |
Marketed |
| Acidex Oral Suspension, Sodium Alginate 500mg, Sodium Bicarbonate 267mg, Calcium Carbonate 160mg/10ml PA0281/075/001 |
Sodium alginate, Sodium bicarbonate, Calcium carbonate |
Pinewood Laboratories Ltd |
Marketed |
| Aclasta 5 mg solution for infusion EU/1/05/308/001 |
Zoledronic acid |
Sandoz Pharmaceuticals d.d. |
— |
| Acnecide 5% w/w Gel PA22743/001/001 |
Benzoyl Peroxide |
Galderma International |
Marketed |
| Acnecide Wash 5 % w/w Gel PA22743/001/002 |
Benzoyl Peroxide |
Galderma International |
Marketed |
| Aconite HOR1149/001/001 |
Aconitum napellus |
A. Nelson & Company Limited |
Not marketed |
| 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 |
| Actelsar HCT 40 mg/12.5 mg tablets EU/1/13/817/001-013 |
Hydrochlorothiazide, Telmisartan |
Actavis Group hf |
— |
| Actelsar HCT 80 mg/12.5 mg tablets EU/1/13/817/014-028 |
Hydrochlorothiazide, Telmisartan |
Actavis Group hf |
— |
| Actelsar HCT 80 mg/25 mg tablets EU/1/13/817/029-041 |
Hydrochlorothiazide, Telmisartan |
Actavis Group hf |
— |
| ACTIFED 30 mg/1.25 mg per 5 ml Syrup PA23490/029/001 |
PSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE |
JNTL Consumer Health I (Ireland) Limited |
Not marketed |
| Actifed 60mg/2.5mg Tablets PA23490/029/002 |
PSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE |
JNTL Consumer Health I (Ireland) Limited |
Marketed |
| Actilyse 10 mg powder and solvent for solution for injection and infusion PA0775/011/001 |
Alteplase |
Boehringer Ingelheim International GmbH |
Marketed |
| Actilyse 20 mg powder and solvent for solution for injection and infusion PA0775/011/002 |
Alteplase |
Boehringer Ingelheim International GmbH |
Marketed |