| Augmentin 250 mg/125 mg film-coated tablets PA1077/093/007 |
Amoxicillin, Clavulanic acid |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Augmentin 500 mg/125 mg film-coated tablets PA1077/019/003 |
Amoxicillin, Clavulanic acid |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Augmentin 875 mg/125 mg film-coated tablets PA1077/019/005 |
Amoxicillin, Clavulanic acid |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Augmentin Duo Mixed Fruit 400 mg/57 mg/5 ml Powder for Oral Suspension PA1077/019/006 |
Amoxicillin, Clavulanic acid |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Augmentin Paediatric 125 mg/31.25 mg per 5 ml Powder for Oral Suspension PA1077/093/004 |
Amoxicillin, Clavulanic acid |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Avodart 0.5 mg soft capsules PA1077/104/001 |
Dutasteride |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Bactroban 2% w/w Nasal Ointment PA1077/094/002 |
Mupirocin calcium |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Bactroban 2% w/w Ointment PA1077/094/001 |
Mupirocin |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Becotide Evohaler 100 micrograms, Pressurised Inhalation Solution PA1077/042/007 |
Beclometasone dipropionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Becotide Evohaler 250 micrograms, Pressurised Inhalation Solution PA1077/042/009 |
Beclometasone dipropionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Becotide Evohaler 50 micrograms, Pressurised Inhalation Solution PA1077/042/006 |
Beclometasone dipropionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Benlysta 120 mg powder for concentrate for solution for infusion EU/1/11/700/001-002 |
Belimumab |
GlaxoSmithKline (Ireland) Limited |
— |
| Benlysta 200 mg solution for injection in pre-filled pen EU/1/11/700/003-005 |
Belimumab |
GlaxoSmithKline (Ireland) Limited |
— |
| Benlysta 200 mg solution for injection in pre-filled syringe EU/1/11/700/006-007 |
Belimumab |
GlaxoSmithKline (Ireland) Limited |
— |
| Betnovate Cream 0.1% w/w PA1077/001/001 |
Betamethasone |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Betnovate Ointment 0.1% w/w PA1077/001/002 |
Betamethasone valerate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Betnovate Scalp Application 0.1% w/w Cutaneous Solution PA1077/001/003 |
Betamethasone |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Boostrix suspension for injection in pre-filled syringe Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) PA1077/020/001 |
Pertactin, Filamentous haemagglutinin, Pertussis toxoid, Tetanus toxoid, Diphtheria toxoid |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Combodart 0.5 mg/ 0.4 mg hard capsules PA1077/118/001 |
Dutasteride, Tamsulosin hydrochloride |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Dermovate 0.05% w/w Cream PA1077/005/001 |
Clobetasol propionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Dermovate 0.05% w/w Ointment PA1077/005/002 |
Clobetasol propionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Dermovate Scalp Application 0.05% w/v Cutaneous Solution PA1077/005/003 |
Clobetasol propionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Duac Once Daily 10mg/g + 50mg/g Gel PA1077/120/001 |
CLINDAMYCIN PHOSPHATE, Benzoyl peroxide hydrous |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Engerix B 20 micrograms/1 ml Suspension for injection in pre-filled syringe Hepatitis B (rDNA) vaccine (adsorbed) (HBV) PA1077/023/002 |
Hepatitis b surface antigen, recominant |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Eumovate Cream 0.05% w/w PA1077/006/001 |
CLOBETASONE BUTYRATE |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Flixotide Diskus 100 micrograms, Inhalation Powder, pre-dispensed PA1077/044/010 |
Fluticasone propionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Flixotide Diskus 250 micrograms, Inhalation Powder, pre-dispensed PA1077/044/011 |
Fluticasone propionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Flixotide Diskus 50 micrograms, Inhalation Powder, pre-dispensed PA1077/044/009 |
Fluticasone propionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Flixotide Diskus 500 micrograms, Inhalation Powder, pre-dispensed PA1077/044/012 |
Fluticasone propionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Flixotide Evohaler 125 micrograms per metered dose Pressurised Inhalation Suspension PA1077/044/014 |
Fluticasone propionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Flixotide Evohaler 250 micrograms per metered dose Pressurised Inhalation, Suspension PA1077/044/015 |
Fluticasone propionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Flixotide Evohaler 50 micrograms per metered dose, Pressurised Inhalation Suspension PA1077/044/013 |
Fluticasone propionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Flolan 0.5 mg powder and solvent for solution for infusion PA1077/058/002 |
Epoprostenol |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Flolan 1.5 mg powder and solvent for solution for infusion PA1077/058/001 |
Epoprostenol |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Fluarix Tetra suspension for injection in pre-filled syringe Influenza vaccine (split virion, inactivated) PA1077/134/001 |
A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238, A/Darwin/9/2021 (H3N2)-like strain (A/Darwin/6/2021, IVR-227), B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, BVR-26) [Victoria lineage], B/PHUKET/3073/2013 -LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE) |
GlaxoSmithKline (Ireland) Limited |
Not marketed |
| Havrix Junior Monodose Vaccine. Hepatitis A Vaccine (Inactivated, Adsorbed). 720 ELISA units/ 0.5ml Suspension for injection in a pre-filled syringe PA1077/026/001 |
Hepatitis A antigen |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Havrix Monodose Vaccine. Hepatitis A Vaccine (inactivated, adsorbed), 1440 ELISA units/ 1ml Suspension for injection in a pre-filled syringe PA1077/026/002 |
Aluminium, Hepatitis A antigen |
GlaxoSmithKline (Ireland) Limited |
Not marketed |
| Hiberix. Haemophilus Type b (Hib) vaccine.Powder and Solvent for Solution for Injection PA1077/027/001 |
Haemophilus influenzae type b polysaccharide |
GlaxoSmithKline (Ireland) Limited |
Not marketed |
| Imigran 10 mg Nasal Spray, Solution PA1077/008/003 |
Sumatriptan |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Imigran 20 mg nasal spray, solution PA1077/008/004 |
Sumatriptan |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Imigran Ftab 100 mg film-coated tablets PA1077/008/007 |
Sumatriptan |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Imigran Ftab 50 mg film-coated tablets PA1077/008/006 |
Sumatriptan |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| IPV Infanrix suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed) PA1077/108/001 |
Pertussis toxoid, Filamentous haemagglutinin, Pertactin, Diphtheria toxoid, Tetanus toxoid |
GlaxoSmithKline (Ireland) Limited |
Not marketed |
| IPV-Boostrix– Suspension for injection in a pre-filled syringeDiphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) PA1077/101/001 |
Diphtheria toxoid, Tetanus toxoid, Pertussis toxoid, Filamentous haemagglutinin, Pertactin |
GlaxoSmithKline (Ireland) Limited |
Not marketed |
| Lamictal 100 mg chewable/dispersible tablets PA1077/061/009 |
Lamotrigine |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Lamictal 100 mg tablets PA1077/061/003 |
Lamotrigine |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Lamictal 2 mg chewable/dispersible tablets PA1077/061/005 |
Lamotrigine |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Lamictal 200 mg chewable/dispersible tablets PA1077/061/010 |
Lamotrigine |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Lamictal 200 mg tablets PA1077/061/004 |
Lamotrigine |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Lamictal 25 mg chewable/dispersible tablets PA1077/061/007 |
Lamotrigine |
GlaxoSmithKline (Ireland) Limited |
Marketed |