This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.
The drug GARDASIL 9 contains a combination of these active pharmaceutical ingredients (APIs):
1
|
UNII
61746O90DY - HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN
|
2
|
UNII
Z845VHQ61P - HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN
|
3
|
UNII
6LTE2DNX63 - HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN
|
4
|
UNII
J2D279PEM5 - HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN
|
5
|
UNII
53JIL371NS - HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN
|
6
|
UNII
759RAC446C - HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN
|
7
|
UNII
68S8VCN34F - HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN
|
8
|
UNII
55644W68FD - HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN
|
9
|
UNII
94Y15HP7LF - HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN
|
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| GARDASIL 9 Suspension for injection | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| J07BM03 | J Antiinfectives for systemic use → J07 Vaccines → J07B Viral vaccines → J07BM Papillomavirus vaccines | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| BR | Câmara de Regulação do Mercado de Medicamentos | 525518080020601, 525518080020701 |
| CA | Health Products and Food Branch | 02437058 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 45-MBE-0116 |
| EE | Ravimiamet | 1687372, 1687383, 1687394 |
| ES | Centro de información online de medicamentos de la AEMPS | 1151007002 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 581896 |
| FR | Base de données publique des médicaments | 65017887 |
| GB | Medicines & Healthcare Products Regulatory Agency | 334932 |
| HK | Department of Health Drug Office | 64239, 66391 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 8254 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1077100, 1077101, 1077102, 1088656 |
| NL | Z-Index G-Standaard, PRK | 196959 |
| NZ | Medicines and Medical Devices Safety Authority | 17829 |
| PL | Rejestru Produktów Leczniczych | 100347350 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W68784001, W68784002 |
| SG | Health Sciences Authority | 15141P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699636951262 |
| US | FDA, National Drug Code | 0006-4119, 0006-4121 |
| ZA | Health Products Regulatory Authority | 51/30.1/0264 |
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