L1 protein, Human papillomavirus type 11 Vaccine / L1 protein, Human papillomavirus type 16 Vaccine / L1 protein, Human papillomavirus type 18 Vaccine / L1 protein, Human papillomavirus type 31 Vaccine / L1 protein, Human papillomavirus type 33 Vaccine / L1 protein, Human papillomavirus type 45 Vaccine / L1 protein, Human papillomavirus type 52 Vaccine / L1 protein, Human papillomavirus type 58 Vaccine / L1 protein, Human papillomavirus type 6 Vaccine Prefilled Syringe
- Brand(s)
- Gardasil 9
- Category(s)
- other
- SPL Type(s)
- Vaccine
- Master SPL
- Merck Sharp & Dohme Corp. (2015-08-06)
- Oldest Current Product
- 2014-12-10
- License(s)
- BLA
- RxNORM
- PREFILLED SYRINGE\L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 11 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 16 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 18 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 31 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 33 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 45 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 52 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 58 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 6 VACCINE
- SPL Active
- INTRAMUSCULAR\INJECTION, SUSPENSION\HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN
- SPL Moiety
- INTRAMUSCULAR\INJECTION, SUSPENSION\HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN
product(s) by strength(s)
0.5 ml l1 protein, human papillomavirus type 11 vaccine 0.08 mg/ml / l1 protein, human papillomavirus type 16 vaccine 0.12 mg/ml / l1 protein, human papillomavirus type 18 vaccine 0.08 mg/ml / l1 protein, human papillomavirus type 31 vaccine 0.04 mg/ml / l1 protein, human papillomavirus type 33 vaccine 0.04 mg/ml / l1 protein, human papillomavirus type 45 vaccine 0.04 mg/ml / l1 protein, human papillomavirus type 52 vaccine 0.04 mg/ml / l1 protein, human papillomavirus type 58 vaccine 0.04 mg/ml / l1 protein, human papillomavirus type 6 vaccine 0.06 mg/ml prefilled syringe
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000064121 | Gardasil 9 | BLA | Merck Sharp & Dohme Corp. | 2014-12-10 | HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN | INTRAMUSCULAR | INJECTION, SUSPENSION | 125508 | a21f4f4b-b891-4f25-b747-cb9ec7d865d6 |
application(s)
| # | id | title | approved | fda division |
|---|---|---|---|---|
| 1 | 125508 | Human Papillomavirus 9-valent Vaccine, RecombinantGardasil 9 Application | 2014-12-10 | CBER |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|
| 1 | a21f4f4b-b891-4f25-b747-cb9ec7d865d6 (view SPL) | These highlights do not include all the information needed to use GARDASIL 9 safely and effectively. See full prescribing information for GARDASIL 9. GARDASIL9 (Human Papillomavirus 9-valent Vaccine, Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 2014 | other | Vaccine | Merck Sharp & Dohme Corp. | 2015-08-06 | 5 | 000064121, 000064119 | L1 protein, Human papillomavirus type 11 Vaccine / L1 protein, Human papillomavirus type 16 Vaccine / L1 protein, Human papillomavirus type 18 Vaccine / L1 protein, Human papillomavirus type 31 Vaccine / L1 protein, Human papillomavirus type 33 Vaccine / L1 protein, Human papillomavirus type 45 Vaccine / L1 protein, Human papillomavirus type 52 Vaccine / L1 protein, Human papillomavirus type 58 Vaccine / L1 protein, Human papillomavirus type 6 Vaccine Injection |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII