| Calpol Six Plus 250 mg/5 ml Oral Suspension PA23490/003/002 |
Paracetamol |
JNTL Consumer Health I (Ireland) Limited |
Not marketed |
| Calpol Six Plus 250 mg/5 ml Sugar/Colour Free Oral Suspension PA23490/003/003 |
Paracetamol |
JNTL Consumer Health I (Ireland) Limited |
Marketed |
| Calpol Six Plus Fastmelts 250 mg Paracetamol orodispersible tablets PA23490/003/005 |
Paracetamol |
JNTL Consumer Health I (Ireland) Limited |
Marketed |
| Canesten HC 1% w/w + 1% w/w Cream PA1410/040/002 |
Clotrimazole, HYDROCORTISONE ACETATE |
Bayer Limited |
— |
| Caspofungin Accord EU/1/15/1081/001 |
Caspofungin acetate |
Accord Healthcare S.L.U. |
— |
| Caspofungin Accord EU/1/15/1081/002 |
Caspofungin acetate |
Accord Healthcare S.L.U. |
— |
| Caspofungin Clonmel 50 mg powder for concentrate for solution for infusion PA0126/341/001 |
Caspofungin acetate |
Clonmel Healthcare Ltd |
Marketed |
| Caspofungin Clonmel 70 mg powder for concentrate for solution for infusion PA0126/341/002 |
Caspofungin acetate |
Clonmel Healthcare Ltd |
Marketed |
| Cetrotide 0.25 mg powder and solvent for solution for injection EU/1/99/100/001 |
Cetrorelix acetate |
Merck Europe B.V. |
— |
| Cetrotide 0.25 mg powder and solvent for solution for injection EU/1/99/100/002 |
Cetrorelix acetate |
Merck Europe B.V. |
— |
| Chlorhexidine acetate 0.015% w/v and Cetrimide 0.15% w/v Irrigation solution PA2299/005/001 |
Chlorhexidine acetate, Cetrimide |
Baxter Holding B.V. |
Not marketed |
| Chlorhexidine Acetate BP 0.05% w/v Irrigation solution PA2299/004/001 |
Chlorhexidine acetate |
Baxter Holding B.V. |
Marketed |
| Co-codamol 15 mg/500 mg film-coated tablets PA22871/020/001 |
Paracetamol, Codeine phosphate hemihydrate |
Azure Pharmaceuticals Ltd. |
Marketed |
| Co-Tipol 500 mg/30 mg hard capsules PA0126/332/001 |
Paracetamol, Codeine phosphate hemihydrate |
Clonmel Healthcare Ltd |
Not marketed |
| Co-Tipol 500 mg/30 mg suppositories PA0126/332/002 |
Paracetamol, Codeine phosphate hemihydrate |
Clonmel Healthcare Ltd |
Not marketed |
| Co-Tipol Max 1000 mg/60 mg suppositories PA0126/332/003 |
Paracetamol, Codeine phosphate hemihydrate |
Clonmel Healthcare Ltd |
Marketed |
| Codipar 15 mg/ 500 mg Capsules PA1142/023/002 |
Paracetamol, Codeine phosphate hemihydrate |
Amdipharm Limited |
Marketed |
| Combileve 500 mg/200 mg film-coated tablets PA1113/032/001 |
Paracetamol, Ibuprofen |
Phoenix Labs |
Not marketed |
| Combogesic 10 mg/ml Paracetamol + 3 mg/ml Ibuprofen solution for infusion PA23183/002/001 |
Paracetamol, Ibuprofen sodium dihydrate |
Jed Pharma Limited |
Marketed |
| Copaxone 20 mg/ml solution for injection in pre-filled syringe PA22579/001/001 |
Glatiramer acetate |
TEVA GmbH |
Marketed |
| Copaxone 40 mg/ml solution for injection in pre-filled syringe PPA0465/432/002 |
Glatiramer acetate |
PCO Manufacturing Ltd. |
— |
| Copaxone 40mg/ml solution for injection in pre-filled syringe PA22579/001/002 |
Glatiramer acetate |
TEVA GmbH |
Marketed |
| DDAVP/Desmopressin 4 micrograms/ml Solution for Injection PA1009/001/002 |
DESMOPRESSIN ACETATE |
Ferring Ireland Ltd |
Marketed |
| Degarelix Accord 120 mg powder and solvent for solution for injection EU/1/23/1753/003 |
Degarelix Acetate |
Accord Healthcare S.L.U. |
— |
| Degarelix Accord 80 mg powder and solvent for solution for injection EU/1/23/1753/001-002 |
Degarelix Acetate |
Accord Healthcare S.L.U. |
— |
| Depo-Medrone 40 mg/ml Suspension for Injection 1 ml vial PA0822/122/001 |
Methylprednisolone acetate |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Depo-Medrone 40 mg/ml Suspension for Injection 2 ml vial PA0822/122/002 |
Methylprednisolone acetate |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Depo-Medrone 40 mg/ml Suspension for Injection 3 ml vial PA0822/122/003 |
Methylprednisolone acetate |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Depo-Medrone 40mg/ml with Lidocaine 10mg/ml Suspension for Injection, 2ml vial PA0822/123/002 |
Methylprednisolone acetate, Lidocaine hydrochloride |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Depo-Provera 150 mg/ml Suspension for Injection PA0822/124/001 |
Medroxyprogesterone acetate |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Desmotabs Melt 120 micrograms oral lyophilisate PPA1463/174/001 |
DESMOPRESSIN ACETATE |
IMED Healthcare Ltd., |
— |
| Diamox 250 mg Tablets PA1142/020/003 |
Acetazolamide |
Amdipharm Limited |
Marketed |
| Diamox SR 250mg Modified Release Hard Capsules PA1142/020/001 |
Acetazolamide |
Amdipharm Limited |
Not marketed |
| Dianette 2 mg/35 microgram coated tablets PA1410/003/001 |
Cyproterone acetate, Ethinylestradiol ph.eur. |
Bayer Limited |
Marketed |
| Dianette 2 mg/35 microgram coated tablets PPA0465/050/001 |
Cyproterone acetate, Ethinylestradiol |
PCO Manufacturing Ltd. |
— |
| Dianette 2 mg/35 microgram coated tablets PPA1463/164/001 |
Cyproterone acetate, Ethinylestradiol |
IMED Healthcare Ltd., |
— |
| Docetaxel 20 mg/ml concentrate for solution for infusion PA22766/001/001 |
Docetaxel (anhydrous) |
Seacross Pharma (Europe) Limited |
Marketed |
| Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion EU/1/12/769/003 |
Docetaxel |
Accord Healthcare S.L.U. |
— |
| Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion EU/1/12/769/001 |
Docetaxel |
Accord Healthcare S.L.U. |
— |
| Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion EU/1/12/769/002 |
Docetaxel |
Accord Healthcare S.L.U. |
— |
| DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion EU/1/12/770/002 |
Docetaxel |
Fresenius Kabi Deutschland GmbH |
— |
| DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion EU/1/12/770/003 |
Docetaxel |
Fresenius Kabi Deutschland GmbH |
— |
| DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion EU/1/12/770/004 |
Docetaxel |
Fresenius Kabi Deutschland GmbH |
— |
| DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion EU/1/12/770/001 |
Docetaxel |
Fresenius Kabi Deutschland GmbH |
— |
| Docetaxel Mylan EU/1/11/748/001-006 |
Anhydrous docetaxel |
Mylan S.A.S. |
— |
| Dozol Oral Solution Paracetamol 120 mg/5 ml Diphenhydramine Hydrochloride 12.5 mg/5 ml PA1721/005/001 |
Diphenhydramine hydrochloride, Paracetamol |
Phoenix Healthcare Ltd |
Marketed |
| DUAVIVE 0.45 mg/20 mg modified-release tablets EU/1/14/960/001 |
Conjugated estrogens (ce), Bazedoxifene acetate |
Pfizer Europe MA EEIG |
— |
| Easolief Duo 500mg/150mg Film-coated Tablets PA0126/294/001 |
Paracetamol, Ibuprofen |
Clonmel Healthcare Ltd |
Marketed |
| Easolief DUO Hot Drink 500 mg/150 mg powder for oral solution in sachet PA0126/407/001 |
Paracetamol, Ibuprofen lysinate |
Clonmel Healthcare Ltd |
— |
| Easolief DUO Hot Drink Max Strength 1000 mg/300 mg powder for oral solution in sachet PA0126/407/002 |
Paracetamol, Ibuprofen lysinate |
Clonmel Healthcare Ltd |
— |