| Minims Tetracaine Hydrochloride 1% w/v Eye Drops, Solution PA23259/022/002 |
Tetracaine hydrochloride |
Bausch + Lomb Ireland Limited |
Marketed |
| Minims Tropicamide 0.5 % w/v Eye drops, solution PA23259/023/001 |
Tropicamide |
Bausch + Lomb Ireland Limited |
Marketed |
| Minims Tropicamide 1% w/v Eye drops, solution PA23259/023/002 |
Tropicamide |
Bausch + Lomb Ireland Limited |
Marketed |
| Minoxidil for men 5% w/v cutaneous solution PA22753/001/001 |
Minoxidil |
Careforsons Ireland Limited |
Marketed |
| Minulet 75 micrograms/30 micrograms coated tablets PA0822/093/001 |
Ethinyloestradiol, Gestodene |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Mirtazapine 15 mg film-coated tablets PA2315/072/001 |
Mirtazapine |
Accord Healthcare Ireland Ltd. |
Marketed |
| Mirtazapine 30 mg film-coated tablets PA2315/072/002 |
Mirtazapine |
Accord Healthcare Ireland Ltd. |
Marketed |
| Mirtazapine 45 mg film-coated tablets PA2315/072/003 |
Mirtazapine |
Accord Healthcare Ireland Ltd. |
Marketed |
| Molipaxin 100 mg capsules PA23229/011/002 |
Trazodone hydrochloride |
Neuraxpharm Ireland Limited |
Marketed |
| Molipaxin 150mg Film-coated Tablets PA23229/011/003 |
Trazodone hydrochloride |
Neuraxpharm Ireland Limited |
Marketed |
| Molipaxin 50 mg capsules PA23229/011/001 |
Trazodone hydrochloride |
Neuraxpharm Ireland Limited |
Marketed |
| Monadia 50mcg/actuation Nasal spray, suspension PA23198/026/001 |
Mometasone furoate monohydrate |
Organon Pharma (Ireland) Limited |
Not marketed |
| Monotrim 10 mg/ml Oral Suspension PA23081/014/001 |
Trimethoprim |
Taw Pharma (Ireland) Limited |
Marketed |
| Montelukast 10 mg film-coated tablets PA2315/110/003 |
Montelukast |
Accord Healthcare Ireland Ltd. |
Marketed |
| Montelukast Paediatric 4mg Chewable Tablets PA2315/110/001 |
Montelukast |
Accord Healthcare Ireland Ltd. |
Marketed |
| Montelukast Paediatric 5mg Chewable Tablets PA2315/110/002 |
Montelukast |
Accord Healthcare Ireland Ltd. |
Marketed |
| Morphine Sulphate 10mg/ml Solution for Injection PA0073/020/001 |
Morphine sulfate |
Mercury Pharmaceuticals (Ireland) Ltd |
Marketed |
| Morphine Sulphate 1mg/5ml Solution for Injection PA0073/020/003 |
Morphine sulfate |
Mercury Pharmaceuticals (Ireland) Ltd |
Not marketed |
| Morphine Sulphate 30 mg/ml Solution for Injection PA0073/020/004 |
Morphine sulfate |
Mercury Pharmaceuticals (Ireland) Ltd |
Marketed |
| Morphine Sulphate 60 mg/ml Solution for Injection PA0073/020/008 |
Morphine sulfate |
Mercury Pharmaceuticals (Ireland) Ltd |
Marketed |
| Motilium 1 mg/ml Oral Suspension PA23490/039/001 |
Domperidone |
JNTL Consumer Health I (Ireland) Limited |
Not marketed |
| Motilium 10mg Film-Coated Tablets PA23490/022/002 |
Domperidone |
JNTL Consumer Health I (Ireland) Limited |
Marketed |
| Motilium Fastmelts 10mg Orodispersible Tablets PA23490/022/001 |
Domperidone |
JNTL Consumer Health I (Ireland) Limited |
Marketed |
| Motilium Rx 10 mg Film-coated Tablets PA23490/039/002 |
Domperidone |
JNTL Consumer Health I (Ireland) Limited |
Marketed |
| MVASI 25 mg/mL Concentrate for solution for infusion EU/1/17/1246/001-002 |
Bevacizumab |
Amgen Technology (Ireland) Unlimited Company |
— |
| Mycobutin 150mg Hard Capsules PA0822/109/001 |
Rifabutin |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Mycophenolate Mofetil 500 mg film-coated Tablets PA2315/192/001 |
Mycophenolate mofetil |
Accord Healthcare Ireland Ltd. |
Marketed |
| Mycophenolate Mofetil Accord 250 mg capsules PA2315/064/001 |
Mycophenolate mofetil |
Accord Healthcare Ireland Ltd. |
Marketed |
| Myfortic 180 mg gastro-resistant tablets PA0896/023/001 |
Mycophenolic acid |
Novartis Ireland Limited |
Marketed |
| Myfortic 360 mg gastro-resistant tablets PA0896/023/002 |
Mycophenolic acid |
Novartis Ireland Limited |
Marketed |
| Mysimba 8 mg/90 mg prolonged-release tablets EU/1/14/988/001-002 |
Naltrexone hydrochloride, Bupropion hydrochloride |
Orexigen Therapeutics Ireland Limited |
— |
| Naloxone Accord PA2315/254/001 |
Naloxone hydrochloride dihydrate |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Naloxone Hydrochloride 400 micrograms/ml Solution for Injection or Infusion PA0073/111/002 |
NALOXONE HYDROCHLORIDE |
Mercury Pharmaceuticals (Ireland) Ltd |
Marketed |
| Naltrexone Hydrochloride 50mg film-coated tablets PA2315/111/001 |
Naltrexone hydrochloride |
Accord Healthcare Ireland Ltd. |
Marketed |
| Naratriptan 2.5 mg film-coated tablet PA22865/008/001 |
Naratriptan hydrochloride |
Renata Pharmaceuticals (Ireland) Limited |
Not marketed |
| Naseptin 0.1% & 0.5% w/w Nasal Cream PA2325/009/001 |
Chlorhexidine Dihydrochloride, Neomycin sulfate |
Alliance Pharma (Ireland) Limited |
Marketed |
| NASONEX 50 micrograms/actuation Nasal Spray, Suspension PA23198/011/001 |
Mometasone furoate |
Organon Pharma (Ireland) Limited |
Marketed |
| Natpar 100 micrograms/dose powder and solvent for solution for injection EU/1/15/1078/004 |
Parathyroid hormone (rdna) |
Shire Pharmaceuticals Ireland Limited |
— |
| Natpar 25 micrograms/dose powder and solvent for solution for injection EU/1/15/1078/001 |
Parathyroid hormone (rdna) |
Shire Pharmaceuticals Ireland Limited |
— |
| Natpar 50 micrograms/dose powder and solvent for solution for injection EU/1/15/1078/002 |
Parathyroid hormone (rdna) |
Shire Pharmaceuticals Ireland Limited |
— |
| Natpar 75 micrograms/dose powder and solvent for solution for injection EU/1/15/1078/003 |
Parathyroid hormone (rdna) |
Shire Pharmaceuticals Ireland Limited |
— |
| Nazalam 2.5 mg nasal spray, solution in single-dose container PA25573/001/001 |
Midazolam hydrochloride |
Kelso Pharma Ireland Limited |
Not marketed |
| Nazalam 3.75 mg nasal spray, solution in single-dose container PA25573/001/002 |
Midazolam hydrochloride |
Kelso Pharma Ireland Limited |
Not marketed |
| Nazalam 5 mg nasal spray, solution in single-dose container PA25573/001/003 |
Midazolam hydrochloride |
Kelso Pharma Ireland Limited |
Not marketed |
| Nebivolol Accord 5 mg tablets PA2315/247/001 |
Nebivolol hydrochloride |
Accord Healthcare Ireland Ltd. |
Marketed |
| NeisVac-C 0.5 ml Suspension for injection in pre-filled syringe. Meningococcal Group C Polysaccharide Conjugate Vaccine Adsorbed PA0822/183/001 |
Neisseria meningitidis c, Tetanus toxoid |
Pfizer Healthcare Ireland Unlimited Company |
Not marketed |
| Neoral 100 mg/ml concentrate for oral solution PA0896/024/004 |
Ciclosporin |
Novartis Ireland Limited |
Marketed |
| Neoral 100mg Soft Capsules PA0896/024/003 |
Ciclosporin |
Novartis Ireland Limited |
Marketed |
| Neoral 25 mg Soft Capsules PA0896/024/001 |
Ciclosporin |
Novartis Ireland Limited |
Marketed |
| Neoral 50mg Soft Capsules PA0896/024/002 |
Ciclosporin |
Novartis Ireland Limited |
Marketed |