IMOVAX RABIES is a vaccine indicated for the prevention of rabies in all age groups. IMOVAX RABIES is approved for pre-exposure prophylaxis to prevent rabies. IMOVAX RABIES is approved for post-exposure prophylaxis to prevent rabies.
For intramuscular use Each dose of IMOVAX RABIES is 1 mL. Primary Vaccination series : Three-dose schedule: Administer a dose at Day 0, 7, and 21 or 28 OR Two-dose schedule: Administer a dose at Day 0 and 7 Booster : Administer a single dose of IMOVAX RABIES. The United States Centers for Disease Control and Prevention (CDC) has published clinical guidance on administration of booster doses of rabies vaccine depen...
IMOVAX RABIES is supplied in a box (NDC 49281-252-51) with: One vial containing lyophilized vaccine (NDC 49281-246-58). One syringe containing Sterile Water diluent (NDC 49281-263-58). If not already inserted into the syringe, a separate plunger rod is provided. One sterile disposable needle for reconstitution. Reconstitute one vial of the lyophilized vaccine with Sterile Water diluent in the accompanying syringe ...
vaers.hhs.gov
ae.reporting.sanofiIMOVAX RABIES is a vaccine indicated for the prevention of rabies in all age groups.
For intramuscular use
Each dose of IMOVAX RABIES is 1 mL.
Primary Vaccination series:
Booster:
Administer a single dose of IMOVAX RABIES.
The United States Centers for Disease Control and Prevention (CDC) has published clinical guidance on administration of booster doses of rabies vaccine depending on rabies exposure risk and for vaccination of individuals who are immunocompromised or who are receiving chloroquine or drugs related to chloroquine. (1) [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]
Each dose of IMOVAX RABIES is 1 mL.
The IMOVAX RABIES post-exposure prophylaxis schedule depends on whether or not the individual has been previously vaccinated and/or immunized against rabies. The CDC considers individuals to be previously vaccinated if they received one of the recommended cell-culture vaccines either in a pre-exposure or post-exposure prophylaxis regimen, or they received another vaccine regimen (or vaccines other than cell-culture vaccine) and had a documented adequate rabies virus neutralizing antibody (RVNA) response (defined as ≥ 0.5 IU/mL by Rapid Fluorescent Focus Inhibition Test [RFFIT]). (2)
Previously Vaccinated Individuals
In previously vaccinated individuals (see definition above),
Unvaccinated or Immunosuppressed (irrespective of previous vaccination status) Individuals
For individuals who have not previously received rabies vaccine, or who are immunosuppressed,
Individuals with Uncertain Immune Status
In individuals whose RVNA status is not known and who 1) have not received the full recommended regimen of a cell culture vaccine either in a pre-exposure or post-exposure prophylaxis regimen OR 2) received another (non-cell culture) rabies vaccine regimen,
IMOVAX RABIES is supplied in a package containing a vial of lyophilized vaccine, a Luer-Lok prefilled syringe containing 1 mL of Sterile Water diluent with a plunger rod either inserted into the syringe or provided separately, and a sterile reconstitution needle. Reconstitute the lyophilized vaccine with the Sterile Water diluent to form IMOVAX RABIES, as described in the instructions below.
Instructions for vaccine reconstitution
Step 1: Screw the plunger rod into the syringe containing Sterile Water diluent if the plunger rod is provided separately.
| Step 2: Hold the syringe cap (avoid holding the plunger rod or syringe barrel) and unscrew the tip cap by twisting it counterclockwise. |  |
| Step 3: Attach the reconstitution needle to the syringe, by gently twisting the needle clockwise into the syringe until slight resistance is felt. |  |
Step 4: Transfer the entire content of the syringe containing Sterile Water diluent into the vial containing lyophilized vaccine.
Step 5: Gently swirl the vial until completely dissolved. After reconstitution, IMOVAX RABIES is pink to red.
Step 6: Unscrew the syringe from the reconstitution needle to eliminate negative pressure.
Reattach the syringe to the reconstitution needle which has remained in the vial.
Step 7: Withdraw the total content of the vial (approximately 1 mL) containing reconstituted vaccine. Remove the reconstitution needle and discard it.
Step 8: Attach a new sterile needle (as per Step 3) of a proper length and gauge suitable for intramuscular administration.
Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exist, IMOVAX RABIES should not be administered.
Administer IMOVAX RABIES intramuscularly immediately after reconstitution.
For adults and older children, the vaccine should be injected into the deltoid muscle. (4) (5) (6) In infants and small children, the anterolateral aspect of the thigh may be preferable, depending on age and body mass.
Do not administer in the gluteal area [see Warnings and Precautions (5.4)].
Do not administer intradermally [see Warnings and Precautions (5.4)].
For injectable suspension. A single dose after reconstitution is 1 mL.
Pre-exposure Prophylaxis
Do not administer to anyone with a known life-threatening systemic hypersensitivity reaction to any component of the vaccine [See Warnings and Precautions (5.2) and Description (11)].
Post-exposure Prophylaxis
None.
Individuals with altered immunocompetence, including those receiving immunosuppressant therapy, may have reduced immune response to IMOVAX RABIES [See Dosage and Administration (2.1, 2.2) and Drug Interactions (7.1)].
Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of IMOVAX RABIES.
In individuals who have experienced an anaphylactic reaction following a dose of IMOVAX RABIES, the risk of developing rabies must be carefully considered in decisions regarding the discontinuation of post-exposure prophylaxis vaccination.
Serum sickness type reactions have been reported in individuals receiving booster doses of rabies vaccine for pre-exposure prophylaxis. The reaction is characterized by onset approximately 2 to 21 days post-booster, presents with a generalized urticaria, and may also include arthralgia, arthritis, angioedema, nausea, vomiting, fever, and malaise. None of the reported reactions were life-threatening. This has been reported in up to 7% of individuals receiving booster vaccination. (9)
Rare cases of neurologic illness resembling Guillain-Barré syndrome, (10) (11) a transient neuroparalytic illness, that resolved without sequelae in 12 weeks and a focal subacute central nervous system disorder temporally associated with IMOVAX RABIES, have been reported. (12)
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
Vaccination with IMOVAX RABIES may not protect all individuals.
Syncope (fainting) has been reported following vaccination with IMOVAX RABIES. Procedures should be in place to avoid injury from fainting.
In a clinical trial evaluating a five-dose regimen for post-exposure prophylaxis, the commonly reported local adverse reactions (≥25%) were pain, erythema, swelling, and itching; the commonly reported systemic adverse reactions (≥20%) were headache, nausea, abdominal pain, muscle aches, and dizziness.
In a clinical trial evaluating the three-dose regimen for pre-exposure prophylaxis, the most commonly reported adverse reactions (≥10%) were injection site pain (30.4% and 43.5%), headache (27.5% and 19.6%), malaise (23.2% and 17.4%) and myalgia (18.8% and 10.9%) (percentages reflect rates in participants 18 years of age and older and participants 2 years through 17 years of age, respectively), fever (17.4%) (in participants 2 years through 17 years of age).
In a clinical trial evaluating the two-dose regimen for pre-exposure prophylaxis, the most commonly reported adverse reactions (≥10%) were injection site pain (35.4% and 25.7%) and headache (21.3% and 13.9%) (percentages reflect rates in participants 18 years of age and older and participants 2 years through 17 years of age, respectively), malaise (26.0%) and myalgia (22.8%) (in participants 18 years of age and older).
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.
Post-exposure Prophylaxis
Reactions after vaccination with IMOVAX RABIES have been observed. (9) In a study using five doses of IMOVAX RABIES, local reactions such as pain, erythema, swelling or itching at the injection site were reported in about 25% of recipients of IMOVAX RABIES, and mild systemic reactions such as headache, nausea, abdominal pain, muscle aches, and dizziness were reported in about 20% of recipients. (7)
Pre-exposure Prophylaxis
The 2-dose and 3-dose pre-exposure prophylaxis regimens of IMOVAX RABIES were evaluated in two clinical trials.
Study 1 (NCT03700242), a randomized, open-label, controlled multicenter study included healthy participants 2 years of age and older. In this study, the safety analysis set included 228 participants who received a 2-dose pre-exposure prophylaxis regimen (on Day 0 and Day 7) and 115 participants who received a 3-dose pre-exposure prophylaxis regimen (on Day 0, Day 7 and Day 21). Of these participants, 101 were 2 years through 11 years of age (66 received 2-dose regimen, 35 received 3-dose regimen), 46 were 12 years through 17 years of age (35 received 2-dose regimen, 11 received 3-dose regimen), and 196 were 18 years through 59 years of age (127 received 2-dose regimen, 69 received 3-dose regimen).
Study 2 (NCT04127786), an observer blind, randomized, controlled multicenter study included healthy participants 1 year of age and older. In this study, the safety analysis set included 139 participants who received a 2-dose pre-exposure prophylaxis regimen (on Day 0, and Day 7) and 200 participants who received a 3-dose pre-exposure prophylaxis regimen (on Day 0, Day 7, and Day 28). Of those who received the 3-dose pre-exposure prophylaxis regimen, 100 participants were 1 year through 17 years of age (70 from 1 year through 11 years of age and 30 from 12 years through 17 years of age) and 100 participants were 18 years of age and older, including 2 participants 65 years of age and older. Per study design, no participants 1 year through 17 years of age were included in the 2-dose pre-exposure prophylaxis regimen group.
In both Study 1 and 2, solicited local (injection site) and systemic adverse reactions were recorded by participants or by parents/guardians in a diary card daily for 7 days after any dose. At subsequent visits, approximately 7 to 21 days post-vaccination, participants or parents/guardians reviewed diary cards with study investigators and when necessary, made corrections or clarifications. Unsolicited non-serious adverse events were recorded through 28 days after any dose, and serious adverse events were recorded for at least 6 months following the last vaccination.
The solicited adverse reactions that occurred within 7 days following any dose of IMOVAX RABIES in participants 18 years and older and participants 2 years through 17 years of age in Study 1 are presented in Table 1.
| ≥ 18 years of age | 2 years through 17 years of age | |||
|---|---|---|---|---|
| Solicited Adverse Reactions | IMOVAX RABIES 2-dose Pre-exposure Prophylaxis (N=127) | IMOVAX RABIES 3-dose Pre-exposure Prophylaxis (N=69) | IMOVAX RABIES 2-dose Pre-exposure Prophylaxis (N=101) | IMOVAX RABIES 3-dose Pre-exposure prophylaxis (N=46) |
| N = Number of participants who received at least one dose | ||||
| Local (injection site) | ||||
| Pain, any* | 35.4 | 30.4 | 25.7 | 43.5 |
| Pain, Grade 3 | 0.0 | 0.0 | 0.0 | 0.0 |
| Erythema, any† | 0.0 | 2.9 | 1.0 | 2.2 |
| Erythema, Grade 3 | 0.0 | 0.0 | 0.0 | 0.0 |
| Swelling, any† | 0.0 | 1.4 | 2.0 | 6.5 |
| Swelling, Grade 3 | 0.0 | 0.0 | 0.0 | 0.0 |
| Systemic | ||||
| Fever, any‡ | 4.7 | 7.2 | 4.0 | 17.4 |
| Fever, Grade 3 | 0.8 | 1.4 | 2.0 | 2.2 |
| Headache, any§ | 21.3 | 27.5 | 13.9 | 19.6 |
| Headache, Grade 3 | 0.0 | 0.0 | 0.0 | 0.0 |
| Malaise, any§ | 26.0 | 23.2 | 9.9 | 17.4 |
| Malaise, Grade 3 | 0.8 | 0.0 | 0.0 | 0.0 |
| Myalgia, any§ | 22.8 | 18.8 | 5.9 | 10.9 |
| Myalgia, Grade 3 | 0.0 | 0.0 | 0.0 | 0.0 |
* Any: From "easily tolerated" to "unable to perform usual activities" (2 years through 11 years of age) or from "no interference" to "significant interference with daily activities" (> 12 years); Grade 3: Unable to perform usual activities (2 years through 11 years of age) and prevents daily activity (>12 years)
† Any: 0 mm (2 years through 11 years of age) and ≥ 25 mm (>12 years); Grade 3: 50 mm (2 years through 11 years) and > 100 mm (>12 years)
‡ Any: ≥ 100.4°F (38.0°C); Grade 3: ≥ 102.1°F (39.0°C)
§ Any: From "no interference" to "significant interference with daily activities"; Grade 3: Prevents daily activity
In Study 2 participants, the commonly reported adverse reactions were generally consistent with those reported in Study 1 participants. In the two participants 1 year to less than 2 years of age in Study 2, the only reported systemic adverse reactions were vomiting and abnormal crying, both occurring in the same participant.
In both Study 1 and Study 2, most solicited adverse reactions resolved within 3 days. No related serious adverse events or deaths were reported in either study.
The following additional adverse events have been identified during postmarketing use of IMOVAX RABIES. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to IMOVAX RABIES exposure.
Blood and Lymphatic System Disorders
Lymphadenopathy
Immune System Disorders
Anaphylactic reaction, serum sickness type reaction, dermatitis allergic, pruritus (itching), edema
Nervous System Disorders
Paresthesia, neuropathy, convulsion, encephalitis, syncope
Gastrointestinal Disorders
Vomiting, diarrhea
Musculoskeletal and Connective Tissue Disorders
Arthralgia
General Disorders and Administration Site Conditions
Asthenia, malaise, fever and chills (shivering), injection site hematoma
Respiratory, Thoracic, and Mediastinal Disorders
Wheezing, dyspnea
Corticosteroids, other immunosuppressive agents or treatments, and immunosuppressive illnesses can interfere with the development of active immunity and predispose the patient to developing rabies [See Dosage and Administration (2.1, 2.2)]. Immunosuppressive agents should not be administered during post-exposure prophylaxis, unless essential for the treatment of other conditions. When rabies post-exposure prophylaxis is administered to individuals receiving steroids or other immunosuppressive therapy, it is especially important that serum be tested for an RVNA titer to ensure that an adequate response has developed. (3)
Risk Summary
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
There are no adequate and well-controlled studies of IMOVAX RABIES in pregnant women. Data on IMOVAX RABIES administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
Animal reproduction studies have not been conducted with IMOVAX RABIES.
Clinical considerations
Disease-Associated Maternal and/or Embryo/Fetal Risk
Confirmed rabies infection nearly always results in death.
Risk Summary
It is not known whether IMOVAX RABIES is excreted in human milk. Data are not available to assess the effects of IMOVAX RABIES on the breastfed infant or on milk production/excretion.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for IMOVAX RABIES and any potential adverse effects on the breastfed child from IMOVAX RABIES or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine.
Safety and efficacy have been established in all pediatric age groups [See Adverse Reactions (6.1) and Clinical Studies (14)].
Clinical studies of IMOVAX RABIES did not include sufficient numbers of participants aged 65 and over to determine whether they respond differently from younger participants [See Adverse Reactions (6.1) and Clinical Studies (14)].
IMOVAX RABIES (Rabies Vaccine) is a sterile, injectable suspension for intramuscular use. IMOVAX RABIES is supplied as a vial of lyophilized vaccine which must be reconstituted with the accompanying Sterile Water diluent. The vaccine is prepared from rabies vaccine virus strain PM-1503-3M.
The vaccine virus is harvested from infected human diploid cells, MRC-5 cell line, concentrated by ultrafiltration and is inactivated by beta-propiolactone. One dose of reconstituted vaccine contains less than 100 mg human albumin, less than 150 mcg neomycin sulfate and 20 mcg of phenol red indicator. Beta-propiolactone, a residual component of the manufacturing process, is present in less than 50 parts per million. IMOVAX RABIES contains no preservative.
The potency of one dose (1 mL) of IMOVAX RABIES is equal to or greater than 2.5 international units (IU) of rabies antigen.
The vial stopper, the plunger rod and the tip cap of the syringe are not made with natural rubber latex.
Protection after vaccination is provided by the induction of rabies virus neutralizing antibodies.
IMOVAX RABIES has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility in animals.
Three-dose regimen for pre-exposure prophylaxis
Antibody responses to IMOVAX RABIES have been demonstrated in trials conducted in England (13), Germany (14) (15), France (16) and Belgium. (17) In the US, IMOVAX RABIES resulted in geometric mean titers (GMT) of 12.9 IU/mL at Day 49 and 5.1 IU/mL at Day 90 when three doses were given intramuscularly during the course of one month. The range of RVNA responses was 2.8 to 55.0 IU/mL at Day 49 and 1.8 to 12.4 IU/mL at Day 90. (18) The definition of a minimally accepted RVNA titer varies among laboratories and is influenced by the type of test conducted. The thresholds for an adequate immune response used in these trials were either 1:5 or 0.5 IU/mL depending on the trials.
Two-dose regimen for pre-exposure prophylaxis
The two-dose regimen (on Day 0, and Day 7) was assessed in two phase 3 studies.
In one observer-blind, randomized, controlled, multicenter study conducted in Thailand (Study 2), RVNA responses after 2 doses of IMOVAX RABIES were compared to RVNA responses after 3 doses of IMOVAX RABIES. In this study, 100 healthy participants 18 years of age and older (including 2 participants 65 years of age and older), and 100 participants 1 year through 17 years of age received a 3-dose pre-exposure prophylaxis regimen of IMOVAX RABIES. A key secondary objective of the study was to demonstrate in the pooled participants (from 1 year through 17 years of age and 18 years of age and older), the noninferiority of a 2-dose pre-exposure prophylaxis regimen of IMOVAX RABIES (on Day 0, and Day 7) at Day 28 compared to the 3-dose pre-exposure prophylaxis regimen of IMOVAX RABIES (on Day 0, Day 7, and Day 28) at Day 42 in terms of the percentage of participants with an RVNA titer ≥ 0.5 IU/mL. The analysis was done in the per protocol analysis set (PPAS) with data from Day 28 and Day 42 contributed from the same participants, and with the prespecified noninferiority margins of -10% and -5%.
At Day 28 (after 2 doses of IMOVAX RABIES), 98.8% of participants had an RVNA titer ≥ 0.5 IU/mL. At Day 42 (after 3 doses of IMOVAX RABIES), 100% participants had an RVNA titer ≥ 0.5 IU/mL. The difference in the percentage of participants who achieved an RVNA titer ≥ 0.5 IU/mL was -1.3% [95% confidence interval (CI): -4.4; 1.3]. As the lower bound of the 95% CI of this difference (-4.4%) was greater than the prespecified noninferiority margins of -10% and -5%, noninferiority of the 2-dose pre-exposure prophylaxis regimen at Day 28 to the 3-dose pre-exposure prophylaxis regimen at Day 42 was demonstrated.
In an open-label, randomized, controlled, multicenter study (Study 1) conducted in the Philippines, 228 healthy participants (including 101 participants from 2 years through 17 years of age and 127 participants 18 years through 52 years of age) were randomized to receive the 2-dose pre-exposure prophylaxis regimen of IMOVAX RABIES and 115 healthy participants (including 46 participants from 2 years through 17 years of age and 69 participants 18 years through 59 years of age) were randomized to receive a 3-dose pre-exposure prophylaxis regimen of IMOVAX RABIES. One year later, 200 participants from the 2-dose pre-exposure prophylaxis group and 107 participants from the 3-dose pre-exposure prophylaxis group received two doses of IMOVAX RABIES 3 days apart (on Day 0 and Day 3) to mimic a post-exposure prophylaxis regimen without actual rabies exposure (simulated post-exposure prophylaxis).
The primary objective of the study was to demonstrate noninferiority of a 2-dose pre-exposure prophylaxis regimen of IMOVAX RABIES (on Day 0 and Day 7) at Day 21 compared with the 3-dose pre-exposure prophylaxis regimen of IMOVAX RABIES (on Day 0, Day 7 and Day 28) at Day 35, in terms of the percentage of participants with an RVNA titer ≥ 0.5 IU/mL. The analysis was done in the PPAS with the prespecified noninferiority margin of -5%.
At Day 21, 96.7% of participants who received the 2-dose pre-exposure prophylaxis regimen of IMOVAX RABIES had an RVNA titer ≥ 0.5 IU/mL. At Day 35, 100% participants who received the 3-dose pre-exposure prophylaxis regimen of IMOVAX RABIES had an RVNA titer ≥ 0.5 IU/mL. Noninferiority was not demonstrated as the difference in the percentage of participants who had an RVNA titer ≥ 0.5 IU/mL threshold was ‑3.3% (95% CI: -6.8; 0.5) and the lower bound of the 95% CI was below the prespecified noninferiority margin (‑5%). All participants 2 years through 17 years of age who received the 2-dose pre-exposure prophylaxis regimen of IMOVAX RABIES had an RVNA titer ≥ 0.5 IU/mL at Day 21.
One year later, following the simulated post-exposure prophylaxis, 100% of participants primed with either a 2-dose or 3-dose pre-exposure prophylaxis regimen of IMOVAX RABIES had an RVNA titer ≥ 0.5 IU/mL at 7 and 14 days after the first simulated post-exposure prophylaxis injection, which demonstrated an anamnestic response.
Post-exposure efficacy of IMOVAX RABIES was demonstrated during clinical experience in Iran in which six 1 mL doses were given on Days 0, 3, 7, 14, 30, and 90, in conjunction with antirabies serum. Forty-five individuals severely bitten by rabid dogs and wolves received IMOVAX RABIES within hours of and up to 14 days after the bites. All individuals were fully protected against rabies. (19)
Studies conducted by the CDC have shown that a regimen of 1 dose of Rabies Immune Globulin (RIG) and 5 doses of IMOVAX RABIES induced a sufficient antibody response in all recipients. Of 511 individuals bitten by proven rabid animals and so treated, none developed rabies. (7)
IMOVAX RABIES is supplied in a box (NDC 49281-252-51) with:
Reconstitute one vial of the lyophilized vaccine with Sterile Water diluent in the accompanying syringe to form IMOVAX RABIES. A single dose after reconstitution is 1 mL.
Storage before Reconstitution
Store refrigerated between 2°C and 8°C (35°F to 46°F) in the original carton.
Do not freeze.
Storage after Reconstitution
Administer IMOVAX RABIES immediately after reconstitution.
Advise the vaccine recipient or caregiver to read the FDA-approved labeling.
Inform the vaccine recipient or caregiver about:
ae.reporting.sanofi), or to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or online at vaers.hhs.gov.IMOVAX is a registered trademark of Sanofi Pasteur.
Luer-Lok is a registered trademark of Becton Dickinson and Company.
© 2026 Sanofi Pasteur Inc. – All rights reserved
Manufactured by:
Sanofi Winthrop Industrie
Marcy l'Etoile France
Distributed by:
Sanofi Pasteur Inc.
Swiftwater, PA 18370 USA
1-800-VACCINE (1-800-822-2463)
Rabies
Vaccine
IMOVAX® RABIES
RABIES
(HDCV)
single-dose vial (1 mL)
IM only
Rx only
Mfd by: Sanofi Pasteur SA
Lyon France US Govt Lic #1724
Dist by: Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
1-800-VACCINE (1-800-822-2463)
Sterile Water,
diluent for
reconstitution USP
single-dose (1 mL)
Rx only
Contains no preservative
NDC 49281-252-51
List No 2501
RABIES
(HDCV)
Rabies Vaccine
IMOVAX® RABIES
PRE- AND POSTEXPOSURE
INTRAMUSCULAR IMMUNIZATION ONLY
Single-dose (1 mL)
NOT FOR INTRADERMAL USE
Rx only
Wistar Rabies Virus Strain PM-1503-3M-Grown in Human Diploid Cell
Cultures-Single Dose-Lyophilized Vaccine, Luer Syringe with Sterile water,
diluent for reconstitution
USP, one needle for reconstitution.
FOR INTRAMUSCULAR INJECTION
sanofi
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 830470 | IMOVAX rabies vaccine 2.5 UNT in 1 ML Injection | PSN | 24 |
| 830467 | rabies virus vaccine (generic for Imovax) 2.5 UNT in 1 ML Injection | PSN | 24 |
| 830470 | 1 ML rabies virus vaccine wistar strain PM-1503-3M (human), inactivated 2.5 UNT/ML Injection [Imovax] | SBD | 24 |
| 830467 | 1 ML rabies virus vaccine wistar strain PM-1503-3M (human), inactivated 2.5 UNT/ML Injection | SCD | 24 |
| 830470 | 1 ML Imovax 2.5 UNT/ML Injection | SY | 24 |
| 830470 | Imovax Rabies, Wistar Rabies Virus Strain PM-1503-3M (Human) 2.5 UNT per 1 ML Injection | SY | 24 |
| 830467 | rabies virus vaccine wistar strain PM-1503-3M (human), inactivated 2.5 UNT per 1 ML Injection | SY | 24 |
| Class | Version | Type | Effective |
|---|---|---|---|
| RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | DataBar Limited | (01)00349281246586 | GTIN-14: 00349281246586 GTIN-12: 349281246586 UPC-A: 349281246586 EAN-13: 0349281246586 GTIN storage (14 digits): 00349281246586 | ba8d4e72-f452-4859-ae6f-3644b4b0a78c-03.jpg |
| Barcode | DataBar Limited | (01)00349281263583 | GTIN-14: 00349281263583 GTIN-12: 349281263583 UPC-A: 349281263583 EAN-13: 0349281263583 GTIN storage (14 digits): 00349281263583 | ba8d4e72-f452-4859-ae6f-3644b4b0a78c-04.jpg |
| Barcode | EAN-13 | 0349281252518 | GTIN-13: 0349281252518 EAN-13: 0349281252518 GTIN-12: 349281252518 UPC-A: 349281252518 GTIN storage (14 digits): 00349281252518 | ba8d4e72-f452-4859-ae6f-3644b4b0a78c-05.jpg |
| Data code | Data Matrix | 893606 | ba8d4e72-f452-4859-ae6f-3644b4b0a78c-04.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 99e684e6-f435-feb8-d2bb-3a546f1cb768 | Product name | 2 | 20161117 |
| b045ad64-0f28-9a02-2f9b-b34d94fb2278 | Product name | 1 | 20140508 |
| b6082387-f592-1148-0844-bd068fd213fb | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49281-246-58 | IMOVAX RABIES | 1 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 1 mL | 2.5 [iU] in 1mL | 24 |
| 49281-252-51 | IMOVAX RABIES | 1 in 1 PACKAGE | KIT | 1 | 24 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49281-252-51 | EA - Each | 49281-252 | 1fba0443-69ae-4d8b-a78e-edbd902e83ef | 1 | 2020-05-08 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) | ACTIVE INGREDIENT | C4HQF74XMW | 6 | |
| RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) | ACTIVE MOIETY | C4HQF74XMW | 6 | |
| ALBUMIN (HUMAN) | INACTIVE INGREDIENT | ZIF514RVZR | 6 | |
| NEOMYCIN SULFATE | INACTIVE INGREDIENT | 057Y626693 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49281-252 | 49281-252-51 |
| 49281-246 | 49281-246-58 |
| 49281-263 | 49281-263-58 |
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 103931 | Imovax Rabies | Rabies Vaccine | 351(a) | Rx | 2026-09-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) | C4HQF74XMW | ACTIB |
| ALBUMIN HUMAN | ZIF514RVZR | IACT |
| NEOMYCIN SULFATE | 057Y626693 | IACT |
| PHENOLSULFONPHTHALEIN | I6G9Y0J1OJ | IACT |
| WATER | 059QF0KO0R | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ALBUMIN (HUMAN) | ALBUMIN HUMAN | ZIF514RVZR | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 4212 mg | ||
| ALBUMIN (HUMAN) | ALBUMIN HUMAN | ZIF514RVZR | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 4212 mg |
Adverse event summaries are temporarily unavailable. Other product information remains available.