TicoVac: Package Insert and Label Information (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 0.25 mL Syringe Label

(01)10300690297016

NDC 0069-0297-01
Rx only

Tick-Borne Encephalitis Vaccine

TICOVAC™ 1 through 15 years

One Dose (0.25 mL)

FOR IM USE ONLY
REFRIGERATE
DO NOT FREEZE
SHAKE WELL

Pfizer Ireland PharmaceuticalsUS License No. 2060

PAA180290

LOT/EXP:

Syringe label Ticovac 0.25mL.png
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.25 mL Syringe Carton — 0069-0297-02

NDC 0069-0297-02

Tick-Borne Encephalitis Vaccine

TICOVAC™

For use in individuals aged 1 to 15 yearsFOR INTRAMUSCULAR USE ONLY

1 One-Dose (0.25 mL) Disposable Syringe

Rx only

Pfizer

PRINCIPAL DISPLAY PANEL -- 0.25 mL Syringe Carton -- 0069-0297-02
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.25 mL Syringe Carton — 0069-0297-10

NDC 0069-0297-10

Tick-Borne Encephalitis Vaccine

TICOVAC™

For use in individuals aged 1 to 15 yearsFOR INTRAMUSCULAR USE ONLY

10 One-Dose (0.25 mL) Disposable Syringes

Rx only

Pfizer

PRINCIPAL DISPLAY PANEL -- 0.25 mL Syringe Carton -- 0069-0297-10
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Label

(01)10300690411016

NDC 0069-0411-01
Rx only

Tick-Borne Encephalitis Vaccine

TICOVAC™
16 years and older

One Dose (0.5 mL)
FOR IM USE ONLY
REFRIGERATE
DO NOT FREEZE
SHAKE WELL

Pfizer Ireland PharmaceuticalsUS License No. 2060

PAA180461

LOT/EXP:

Syringe label 0.5mL.png
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Carton — 0069-0411-02

NDC 0069-0411-02

Tick-Borne Encephalitis Vaccine

TICOVAC™

For use in individuals 16 years of age and olderFOR INTRAMUSCULAR USE ONLY

1 One-Dose (0.5 mL) Disposable Syringe

Rx only

Pfizer

PPRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Carton -- 0069-0411-02
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Carton — 0069-0411-10

NDC 0069-0411-10

Tick-Borne Encephalitis Vaccine
TICOVAC™

For use in individuals 16 years of age and olderFOR INTRAMUSCULAR USE ONLY

10 One-Dose (0.5 mL) Disposable Syringes

Rx only

Pfizer

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Carton -- 0069-0411-10
(click image for full-size original)
TICOVAC tick-borne encephalitis vaccine injection
Product Information
Product Type VACCINE Item Code (Source) NDC:0069-0297
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TICK-BORNE ENCEPHALITIS PURIFIED ANTIGEN (FORMALDEHYDE INACTIVATED) (TICK-BORNE ENCEPHALITIS PURIFIED ANTIGEN (FORMALDEHYDE INACTIVATED)) TICK-BORNE ENCEPHALITIS PURIFIED ANTIGEN (FORMALDEHYDE INACTIVATED) 1.2 ug in 0.25 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 1.725 mg in 0.25 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 0.11 mg in 0.25 mL
MONOBASIC POTASSIUM PHOSPHATE 0.0225 mg in 0.25 mL
WATER
ALGELDRATE 0.175 mg in 0.25 mL
ALBUMIN HUMAN 0.25 mg in 0.25 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-0297-02 1 SYRINGE in 1 CARTON contains a SYRINGE (0069-0297-01)
1 NDC:0069-0297-01 0.25 mL in 1 SYRINGE This package is contained within the CARTON (0069-0297-02)
2 NDC:0069-0297-10 10 SYRINGE in 1 CARTON contains a SYRINGE (0069-0297-01)
2 NDC:0069-0297-01 0.25 mL in 1 SYRINGE This package is contained within the CARTON (0069-0297-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125740 06/27/2022
TICOVAC tick-borne encephalitis vaccine injection
Product Information
Product Type VACCINE Item Code (Source) NDC:0069-0411
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TICK-BORNE ENCEPHALITIS PURIFIED ANTIGEN (FORMALDEHYDE INACTIVATED) (TICK-BORNE ENCEPHALITIS PURIFIED ANTIGEN (FORMALDEHYDE INACTIVATED)) TICK-BORNE ENCEPHALITIS PURIFIED ANTIGEN (FORMALDEHYDE INACTIVATED) 2.4 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 3.45 mg in 0.5 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 0.22 mg in 0.5 mL
MONOBASIC POTASSIUM PHOSPHATE 0.045 mg in 0.5 mL
WATER
ALGELDRATE 0.35 mg in 0.5 mL
ALBUMIN HUMAN 0.5 mg in 0.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-0411-02 1 SYRINGE in 1 CARTON contains a SYRINGE (0069-0411-01)
1 NDC:0069-0411-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0069-0411-02)
2 NDC:0069-0411-10 10 SYRINGE in 1 CARTON contains a SYRINGE (0069-0411-01)
2 NDC:0069-0411-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0069-0411-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125740 10/25/2021
Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)
Establishment
Name Address ID/FEI Operations
Pfizer Manufacturing Belgium NV 370156507 ANALYSIS (0069-0297), ANALYSIS (0069-0411), MANUFACTURE (0069-0297), MANUFACTURE (0069-0411), PACK (0069-0297), PACK (0069-0411), LABEL (0069-0297), LABEL (0069-0411)
Establishment
Name Address ID/FEI Operations
Pfizer Manufacturing Austria GmbH 300453240 ANALYSIS (0069-0297), ANALYSIS (0069-0411), API MANUFACTURE (0069-0297), API MANUFACTURE (0069-0411)

Revised: 09/2022 Pfizer Laboratories Div Pfizer Inc

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