GARDASIL 9 Suspension for injection Ref.[28336] Active ingredients: L1 protein of human papillomavirus type 11 L1 protein of human papillomavirus type 16 L1 protein of human papillomavirus type 18 L1 protein of human papillomavirus type 31 L1 protein of human papillomavirus type 33 L1 protein of human papillomavirus type 45 L1 protein of human papillomavirus type 52 L1 protein of human papillomavirus type 58 L1 protein of human papillomavirus type 6

Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

Gardasil 9 suspension for injection.

Gardasil 9 suspension for injection in a pre-filled syringe.

Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed).

Pharmaceutical Form
Suspension for injection. Clear liquid with white precipitate.

Qualitative and quantitative composition

1 dose (0.5 ml) contains approximately:

Human Papillomavirus¹ Type 6 L1 protein^2,3: 30 micrograms
Human Papillomavirus¹ Type 11 L1 protein^2,3: 40 micrograms
Human Papillomavirus¹ Type 16 L1 protein^2,3: 60 micrograms
Human Papillomavirus¹ Type 18 L1 protein^2,3: 40 micrograms
Human Papillomavirus¹ Type 31 L1 protein^2,3: 20 micrograms
Human Papillomavirus¹ Type 33 L1 protein^2,3: 20 micrograms
Human Papillomavirus¹ Type 45 L1 protein^2,3: 20 micrograms
Human Papillomavirus¹ Type 52 L1 protein^2,3: 20 micrograms
Human Papillomavirus¹ Type 58 L1 protein^2,3: 20 micrograms

¹ Human Papillomavirus = HPV.
² L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
³ Adsorbed on amorphous aluminium hydroxyphosphate sulfate adjuvant (0.5 milligrams Al).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
L1 protein of human papillomavirus type 11
L1 protein of human papillomavirus type 16
L1 protein of human papillomavirus type 18
L1 protein of human papillomavirus type 31
L1 protein of human papillomavirus type 33
L1 protein of human papillomavirus type 45
L1 protein of human papillomavirus type 52
L1 protein of human papillomavirus type 58
L1 protein of human papillomavirus type 6

List of Excipients
Sodium chloride Histidine Polysorbate 80 Borax Water for injections For adjuvant, see section 2.

Pack sizes and marketing

Gardasil 9 suspension for injection:

0.5 ml suspension in a vial (glass) with stopper (halobutyl) and a flip-off plastic cap (aluminium crimp band) in a pack size of 1.

Gardasil 9 suspension for injection in a pre-filled syringe:

0.5 ml suspension in a pre-filled syringe (glass) with plunger stopper (siliconised FluroTec-laminated bromobutyl elastomer) and a tip cap (synthetic isoprene-bromobutyl blend) in pack sizes of 1 or 10 with needles or in a pack size of 10 without needles.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/15/1007/001
EU/1/15/1007/002
EU/1/15/1007/003
EU/1/15/1007/004

Date of first authorisation: 10 June 2015
Date of latest renewal: 16 January 2020

Drugs

Drug	Countries
GARDASIL 9	Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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