| Temozolomide FAIR-MED 100 mg hard capsules PA23270/002/003 |
Temozolomide |
Thrive Pharma Ltd. |
Not marketed |
| Temozolomide FAIR-MED 140 mg hard capsules PA23270/002/004 |
Temozolomide |
Thrive Pharma Ltd. |
Not marketed |
| Temozolomide FAIR-MED 180 mg hard capsules PA23270/002/005 |
Temozolomide |
Thrive Pharma Ltd. |
Not marketed |
| Temozolomide FAIR-MED 20 mg hard capsules PA23270/002/002 |
Temozolomide |
Thrive Pharma Ltd. |
Not marketed |
| Temozolomide FAIR-MED 250 mg hard capsules PA23270/002/006 |
Temozolomide |
Thrive Pharma Ltd. |
Not marketed |
| Temozolomide FAIR-MED 5 mg hard capsules PA23270/002/001 |
Temozolomide |
Thrive Pharma Ltd. |
Not marketed |
| Timofluid 1 mg/g eye gel in single-dose container PA1107/003/001 |
Timolol Maleate |
Laboratoires Thea |
Marketed |
| Treosulfan Tillomed 5 g powder for solution for infusion PA2321/003/001 |
Treosulfan |
Laboratorios Tillomed Spain, S.L.U. |
Not marketed |
| Trosyl 283 mg/ml Nail Solution PA0822/197/001 |
Tioconazole |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Trosyl 283 mg/ml Nail Solution PPA0465/247/001 |
Tioconazole |
PCO Manufacturing Ltd. |
— |
| Trosyl 283 mg/ml Nail Solution PPA1463/169/001 |
Tioconazole |
IMED Healthcare Ltd., |
— |
| TRUSOPT Preservative-Free 20 mg/ml eye drops, solution in single-dose container PA0879/004/002 |
Dorzolamide hydrochloride |
Santen OY |
Marketed |
| Ultraproct 0.92 mg/g + 0.9 5mg/g + 5 mg/g Rectal Ointment PA22650/004/001 |
Fluocortolone pivalate, Fluocortolone caproate, Cinchocaine Hydrochloride |
Karo Pharma AB |
Marketed |
| VANFLYTA 17.7 mg film-coated tablets EU/1/23/1768/001-002 |
QUIZARTINIB DIHYDROCHLORIDE |
Daiichi Sankyo Europe GmbH |
— |
| VANFLYTA 26.5 mg film-coated tablets EU/1/23/1768/003-005 |
QUIZARTINIB DIHYDROCHLORIDE |
Daiichi Sankyo Europe GmbH |
— |
| VAQTA Adult 50 U/1 ml, suspension for injection in a prefilled syringe. Hepatitis A vaccine, inactivated, adsorbed. For adults PA1286/056/002 |
Strain cr 326f hepatitis a virus, inactivated 50 u |
Merck Sharp & Dohme Ireland (Human Health) Limited |
Not marketed |
| VAQTA Paediatric 25 U/0.5 mL, suspension for injection in a prefilled syringe. Hepatitis A vaccine, inactivated, adsorbed. For children and adolescents PA1286/056/001 |
Strain cr 326f hepatitis a virus, inactivated 50 u |
Merck Sharp & Dohme Ireland (Human Health) Limited |
Not marketed |
| VARIVAX powder and solvent for suspension for injection in a pre-filled syringe. Varicella Vaccine (live) PA1286/057/001 |
Varicella virus (oka strain) live attenuated |
Merck Sharp & Dohme Ireland (Human Health) Limited |
Marketed |
| Vaxigrip suspension for injection in pre-filled syringe.Trivalent influenza vaccine (split virion, inactivated). PA23458/002/001 |
Influenza Inactivated Split Virus Strain A (H1N1), Influenza Inactivated Split Virus Strain A (H3N2), Influenza Inactivated Split Virus Strain B |
Sanofi Winthrop Industrie |
Marketed |
| Ventizolve 1.26 mg nasal spray, solution in single-dose container PA1270/002/001 |
Naloxone |
Navamedic ASA |
Marketed |
| Verorab, powder and solvent for suspension for injection. Rabies vaccine, inactivated. PA23458/011/001 |
Rabies virus (inactivated) strain wistar (PM/WI 38-1503-3M) |
Sanofi Winthrop Industrie |
Marketed |
| Versatis 700 mg medicated plaster PA2242/007/001 |
Lidocaine |
Grunenthal Pharma Ltd |
Marketed |
| Versatis 700 mg medicated plaster PPA0465/299/001 |
Lidocaine |
PCO Manufacturing Ltd. |
— |
| Versatis 700 mg medicated plaster PPA1463/135/001 |
Lidocaine |
IMED Healthcare Ltd., |
— |
| Versatis 700 mg medicated plaster PPA23080/013/001 |
Lidocaine |
Merit Pharmaceuticals Limited |
— |
| Vesiculture, 30 mg/vial, powder for intravesical suspension. PA2160/005/001 |
MYCOBACTERIUM BOVIS, DANISH STRAIN 1331 |
AJ Vaccines A/S |
Not marketed |
| VISIPAQUE 270 mg I/ml Solution for Injection, glass container PA0735/009/003 |
Iodixanol |
GE Healthcare AS |
Marketed |
| VISIPAQUE 270 mg I/ml Solution for Injection, polypropylene container PA0735/009/012 |
Iodixanol |
GE Healthcare AS |
Marketed |
| VISIPAQUE 320 mg I/ml Solution for Injection, glass container PA0735/009/007 |
Iodixanol |
GE Healthcare AS |
Marketed |
| Visipaque 320 mg I/ml Solution for Injection, polypropylene container PA0735/009/013 |
Iodixanol |
GE Healthcare AS |
Marketed |
| Voltarol Muscle & Joint Pain Relief 140 mg medicated plaster PA0678/140/004 |
Diclofenac sodium |
Haleon Ireland Limited |
Not marketed |
| Wainzua 45 mg solution for injection in pre-filled pen EU/1/24/1875/001 |
Eplontersen sodium |
AstraZeneca AB |
— |
| Water for Injections Ph. Eur., viaflo container PA2299/013/001 |
Water for injection |
Baxter Holding B.V. |
Marketed |
| Winrevair 45 mg powder and solvent for solution for injection EU/1/24/1850/001-002 |
Sotatercept |
Merck Sharp & Dohme BV, |
— |
| Winrevair 60 mg powder and solvent for solution for injection EU/1/24/1850/003-004 |
Sotatercept |
Merck Sharp & Dohme BV, |
— |
| Xerava 100 mg Powder for concentrate for solution for infusion EU/1/18/1312/003-004 |
ERAVACYCLINE |
Paion Pharma GmbH |
— |
| Xerava 50 mg Powder for concentrate for solution for infusion EU/1/18/1312/001 |
ERAVACYCLINE |
Paion Pharma GmbH |
— |
| Xolair 150 mg powder and solvent for solution for injection EU/1/05/319/002 |
Omalizumab |
Novartis Europharm Limited |
— |
| Xolair 150 mg solution for injection in pre-filled syringe EU/1/05/319/8-10 |
Omalizumab |
Novartis Europharm Limited |
— |
| Xolair 300 mg solution for injection in pre-filled pen EU/1/05/319/015-017 |
Omalizumab |
Novartis Europharm Limited |
— |
| Xolair 300 mg solution for injection in pre-filled syringe EU/1/05/319/012-014 |
Omalizumab |
Novartis Europharm Limited |
— |
| Xolair 75 mg powder and solvent for solution for injection EU/1/05/319/001 |
Omalizumab |
Novartis Europharm Limited |
— |
| Xolair 75 mg solution for injection in pre-filled syringe EU/1/05/319/5-7 |
Omalizumab |
Novartis Europharm Limited |
— |
| Xylocaine 10 mg/delivered dose Mucosal Spray PA1691/028/001 |
Lidocaine |
Aspen Pharma Trading Limited |
Marketed |
| Xylocaine 2% w/v with Adrenaline (Epinephrine) 1:80,000 DENTAL Solution for Injection PA1045/003/001 |
Lidocaine hydrochloride, Adrenaline |
DENTSPLY DeTrey GmbH |
Marketed |
| Xylocaine 2% with Adrenaline (Epinephrine) (1:200,000) Solution for Injection PA1691/027/001 |
Lidocaine hydrochloride, Adrenaline |
Aspen Pharma Trading Limited |
Marketed |
| Xylocaine 20mg/g Gel PA1691/037/001 |
Lidocaine Hydrochloride Monohydrate |
Aspen Pharma Trading Limited |
Not marketed |
| Xylonor, 50 mg/g + 1.5 mg/g, gingival gel PA0196/014/002 |
Lidocaine, Cetrimide |
Septodont |
Marketed |
| Zacin 0.025% w/w Cream PA23369/005/001 |
Capsaicin |
Ennogen Healthcare (Europe) Limited |
Marketed |
| Ziremilon 200 mg/ml emulsion for infusion PA1122/040/001 |
Refined olive oil, Fish oil, rich in omega-3 acids, Refined soyabean oil, Medium chain triglycerides |
Noridem Enterprises Limited |
Not marketed |