Japanese Encephalitis Vaccine, Inactivated, Adsorbed (Ixiaro)

Trade Name : IXIARO

Valneva Scotland Ltd.

INJECTION, SUSPENSION, VACCINE

Strength 6 [arb'U]/.5mL

JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) Inactivated Japanese Encephalitis Virus Vaccine [EPC],Actively Acquired Immunity [PE],Japanese Encephalitis Vaccines [CS],Vaccines, Inactivated [CS]

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IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus (JEV). IXIARO is approved for use in individuals 2 months of age and older.

IXIARO is a vaccine indicated for active immunization for the prevention of disease caused by Japanese encephalitis virus (JEV). IXIARO is approved for use in individuals 2 months of age and older. (1)

For intramuscular administration only.n
For intramuscular administration only.
Complete the primary immunization series at least 1 week prior to potential exposure to JEV. (2.1, 14)
Individuals 17 years of age and older who have received a primary immunization series more than 1 year previously may be given a booster dose if ongoing exposure or re-exposure to JEV is expected. (2.1)

IXIARO is a suspension for injection supplied in 0.5 mL single dose syringes. For children 2 months to <3 years of age, a single dose is 0.25 mL. For individuals 3 years of age and older, a single dose is 0.5 mL. [See Dosage and Administration (2.1)]

Suspension for injection supplied in 0.5 mL single dose syringes.

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO, any other Japanese Encephalitis Virus vaccine, or any component of IXIARO, including protamine sulfate, is a contraindication to administration of IXIARO [See Description (11)]. Alternatively, because of uncertainty as to which component of the vaccine may be responsible, individuals with a history of severe allergic reaction to another Japanese Encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.
Severe allergic reaction, (e.g., anaphylaxis,) after a previous dose of IXIARO, any other Japanese Encephalitis Virus vaccine, or any component of IXIARO, including protamine sulfate, is a contraindication to administration of IXIARO. (4)

IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. (5.1)

In infants 2 months to <1 year of age, the most common injection site reaction was redness (>15%); the most common solicited systemic adverse reactions were fever (>20%), irritability (>15%) and diarrhea (>10%). In children 1 to <3 years of age, the most common solicited systemic adverse reaction was fever (>20%). In children 3 to <12 years of age, the most common solicited systemic adverse reaction was fever (>10%). In adolescents 12 to <18 years of age, the most common solicited injection site reactions were pain (15%) and tenderness (10%). In adults 18 years of age and older, the most common injection site reactions were pain (>25%) and tenderness (>25%); the most common solicited systemic adverse reactions were headache (>20%) and myalgia (>10%).
In infants 2 months to <1 year of age, the most common injection site reaction was redness (>15%); the most common solicited systemic adverse reactions were fever (>20%), irritability (>15%) and diarrhea (>10%). (6.1)In children 1 to <3 years of age, the most common solicited systemic adverse reaction was fever (>20%). (6.1)In children 3 to <12 years of age, the most common solicited systemic adverse reaction was fever (>10%). (6.1)In adolescents 12 to <18 years of age, the most common injection site reactions were pain (15%) and tenderness (10%). (6.1)In adults 18 years of age and older, the most common injection site reactions were pain (>25%) and tenderness (>25%); the most common solicited systemic adverse reactions were headache (>20%) and myalgia (>10%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Intercell USA Inc. at 844-349-4276 (8443-IXIARO) or VAERS at 1 800 822 7967 or www.vaers.hhs.gov.

No data

See for and FDAu2011approved patient labeling (Patient Information).
Revised 03/2017

11 DESCRIPTIONIXIARO, Japanese Encephalitis Vaccine, Inactivated, Adsorbed is a sterile suspension for intramuscular injection. Each 0.5 mL dose of vaccine contains 6 antigen units of purified, inactivated JEV and approximately 250 mcg of aluminum hydroxide. The appearance of the liquid is a white, opaque, non-uniform suspension which becomes homogeneous upon shaking.IXIARO is a vaccine prepared by propagating JEV strain SA14-14-2 in Vero cells. Multiple viral harvests are pooled, clarified and concentrated. The virus suspension is treated with protamine sulfate to remove contaminating DNA and proteins. The resulting partially purified virus is processed through a sucrose density gradient centrifugation step and fractionated. Each fraction is analyzed for the presence of virus, and fractions with the highest virus activity are pooled to give a purified virus suspension. The purified virus is then inactivated by treatment with formaldehyde. The preparation is adjusted to a specified antigen content and formulated by addition of aluminum hydroxide.The formulated bulk vaccine is filled into syringes, at a volume of 0.5 mL per syringe. From the manufacturing process, IXIARO also contains: formaldehyde (not more than 200 ppm), bovine serum albumin (not more than 100 ng/mL), host cell DNA (not more than 200 pg/mL), sodium metabisulphite (not more than 200 ppm), host cell protein (not more than 100 ng/mL), and protamine sulfate (not more than 1u00b5g/mL). No preservatives, stabilizers, or antibiotics are added to the formulation.

Japanese encephalitis is a disease caused by the mosquito-borne Japanese encephalitis virus (JEV). IXIARO acts by inducing antibodies that neutralize live JEV. Accumulated data from animal studies, clinical trials of other JE vaccines, and human epidemiological studies, suggest that a virus neutralizing antibody response, as measured in a 50% plaque-reduction neutralization antibody test (PRNT) with a threshold titer of u22651:10, provides evidence of protective immunity. The evaluation of vaccine effectiveness of IXIARO was therefore based on neutralizing antibody response using a threshold PRNTtiter of u22651:10.u00a0

IXIARO has not been evaluated for carcinogenic or mutagenic potential. IXIARO was found to have no effect on fertility of female rats at intramuscular doses of up to 300u2011fold excess relative to the projected human dose (on a mg/kg basis) administered prior to and after mating The effect of IXIARO on male fertility has not been evaluated.

Immunogenicity of IXIARO in a Pediatric Clinical Trial in the Philippines
The immunogenicity of IXIARO was evaluated in a subgroup of children included in a randomized, controlled, open-label clinical trial in healthy children conducted in the Philippines (n in which the safety of IXIARO was compared to control vaccines: HAVRIX (Hepatitis A vaccine, pediatric 720 EL.U./0.5 mL formulation) and Prevnar (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM protein]). Subjects in the IXIARO treatment arm received intramuscular doses on Day 0 and Day 28. A total of 396 subjects from the group receiving an age-appropriate dosage of IXIARO (0.25 mL for infants and children 2 months to <3 years of age or 0.5 mL for individuals 3 to <18 years of age) were randomized in an age-stratified scheme into the immunogenicity subgroup (mean age: 7.7 years; 49.6% female; ethnicity: 100% Asian). [ ]
The immunogenicity evaluation included the proportion of subjects with PRNT titer u22651:10 and geometric mean titer (GMT) at Day 56 and Month 7. The JEV-neutralizing antibody responses elicited by IXIARO in the Intent-to-Treat population (defined as all subjects who received at least one dose of IXIARO) are presented in Table 9.
Table n- 9n- .n- JEV-Neutralizing Antibody Response After IXIARO* Among Children 2 Months to <18 Years of Age Residing in the Philippines, Intent-To-Treat Population**, Study 1n
01041573
*Infants and children u22652 months to <3 years of age received two 0.25 mL doses administered on Days 0 and 28.u00a0 Individuals 3 years of age and older received two 0.5 mL doses administered on Days 0 and 28.
**The Intent to Treat population consisted of all subjects who received at least one dose of IXIARO.
N=number of subjects with data available
n=number of subjects with a PRNT titer u22651:10
u25caReciprocal titers <10 were imputed to 5.
Immunogenicity of IXIARO in a Pediatric Clinical Study in Children 2 Months to <18 Years of Age Traveling from Non-Endemic Countries
The immunogenicity of IXIARO was evaluated in an uncontrolled, open-label clinical study conducted in the United States, Europe and Australia in healthy male and female children with planned travel to JEV-endemic areas n . IXIARO (0.25 mL dose for children 2 months to <3 years of age, 0.5 mL dose for children and adolescents 3 to <18 years of age) was administered by intramuscular injection on Day 0 and Day 28. An analysis was carried out on immunogenicity data for the first 54 subjects enrolled (median age: 15.2u00a0years, range 10 months to 17 years; 59.3% female; ethnicity: White: 81.5%, Asian: 14.8%, Black: 3.7%). n
JEV neutralizing antibody titers were available for 51 subjects at Day 56 (5 subjects 2 months to <3 years of age and 46 subjects 3 to <18 years of age) and for 18 subjects at Month 7 (2 subjects 2 months to <3 years of age and 16 subjects 3 to <18 years of age). All subjects had PRNT titers u22651:10 at Day 56 and Month 7, and GMTs were similar to those among children vaccinated with IXIARO in a study conducted in the Philippines, where JEV is endemic (see Table 9).
Immunogenicity of IXIARO in a Clinical Trial in Adults
Immunogenicity of the vaccine was evaluated in a randomized, activeu2011controlled, observeru2011blinded clinical trial conducted in the U.S., Germany and Austria (Study 4) in 867 healthy adults 18 years of age and older (mean age: 41.3 years; 60.8% female; ethnicity: White 80.8%, Asian 0.8%, Black 13.1%, Other 5.3%). Subjects in the IXIARO treatment arm received the following schedule of three intramuscular doses: Day 0, IXIARO, Day 7, PBS + Al(OH)(0.5 mL phosphate buffered saline with 0.1% aluminum hydroxide), and on Day 28, IXIARO. Subjects in the comparator arm received a subcutaneous dose of 1.0u00a0mL of the USu2011licensed JEV vaccine, JE-VAX, on Days 0, 7 and 28. n
The proportion of subjects with, PRNT titer u22651:10, and GMT were evaluated at Day 56 in the per protocol population which included all subjects who had no major protocol deviations and who had a PRNT titer <1:10 at baseline. The neutralizing antibody responses elicited by IXIARO met predefined statistical criteria for non-inferiority compared to those induced by JEu2011VAX, and are presented in Table 10. All subjects were seronegative at baseline (PRNT titer <1:10).
Table n- 10n- . JEV-Neutralizing Antibody Response After IXIARO or JEu2011VAX Among Adults Residing in Non-Endemic Areas, Per Protocol Population*, Study 4n- Array
00604708
*The Per Protocol population consisted of subjects with no major protocol deviations and a PRNT titer <1:10 at baseline
u2020 Non-inferiority was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in proportion of subjects with PRNT titer u22651:10 (IXIARO minus JEu2011VAX) was >u201110% at Day 56. u2021 Non-inferiority was demonstrated if the lower bound of the 2-sided 95% CI for the GMT ratio (IXIARO /JEu2011VAX) was >1/1.5 at Day 56. n=number of subjects with a PRNT titer u22651:10 N=number of subjects in the Per Protocol Population **N=Number of subjects with immunogenicity data u25caReciprocal titers <10 were imputed to 5.
Temporal Evaluation of Immunogenicity of IXIARO During Vaccination Series in Adults
In a randomized, observer-blinded clinical study in 374 healthy adults 18 years of age and older (Study 5), the immunogenicity of IXIARO was evaluated on days 10, 28, 35, and 56 during the vaccination period.u00a0 The proportion of subjects with PRNT titer u22651:10 at each time point for the subjects randomized to the standard dosing regimen (IXIARO on days 0 and 28) are displayed in Table 11.
Table 11. JEV-Neutralizing Antibody Response During the Vaccination Series (IXIARO on Days 0 and 28) Among Adults Residing in Non-Endemic Areas, Per Protocol Population*, Study 5n
00505790
*The Per Protocol population consisted of all subjects with no major protocol deviations n=number of subjects with a PRNT titer u22651:10
N=number of subjects with immunogenicity data
Persistence of Neutralizing Antibody Response in Adults
The persistence of JEV-neutralizing antibody was evaluated in a subgroup of adult subjects recruited for follow-up after participation in one of two clinical trials (Study 4 and Study 5). In the Intent-to-Treat population of subjects randomized to vaccination with IXIARO (N=181) and in the population of subjects who intended to stay in the study until month 36 (ITT36, N = 152), the proportion of subjects with PRNT titer u22651:10 at 6, 12, 24 and 36 months after initiation of the two-dose series were 95% [95% CI 90.8, 97.4], 83.4% [95% CI 77.3, 88.1] , 81.8% [95% CI 75.5, 86.7] and u00a084.9% [95% CI 78.3, 89.7], respectively.u00a0 Geometric mean titers u00a0(GMT) at 6, 12, 24 and 36 months after initiation of the two-dose series were 83.5 [95% CI 70.9, 98.4], 41.2 [95% CI 34.4, 49.3], 44.3; [95% CI 36.7, 53.4] and 43.8 [95% CI 36.5, 52.6], respectively.
In another study with 116 adults who completed the IXIARO primary immunization series (Study 9), the proportions of subjects with PRNT titers u22651:10 at 11 and 23 months after completion of the primary series were 58.3% [95% CI 49.1, 66.9] and 48.3% [95% CI 39.4, 57.3], respectively, and GMTs were 18.0 [95% CI 14.3, 22.6] and 16.2 [95% CI 12.6, 20.8].
Immunogenicity of IXIARO Booster Doses in Adults
A single booster dose of IXIARO was evaluated in 198 adult subjects enrolled in an uncontrolled, open-label phase 3 study.u00a0 IXIARO was administered 14 months after completion of the primary series (Study 8). The JEV neutralizing antibody responses from this study are presented in Table 12.
Table n- 12n- .n- JEV-Neutralizing Antibody Responsen- Following a Booster Dose of IXIARO Administered 14 Months After Completion of the Primary Series n- Among n- Adults Residing in Non-Endemic Areas, Intent to Treat Population*, Study 8n- Array
00595309
*The Intent to Treat population consisted of all subjects who received the booster vaccination
n=number of subjects with a PRNT titer u22651:10
N=number of subjects with immunogenicity data
The immunogenicity of booster doses was assessed in adult subjectsin another study investigating persistence of immunity following vaccination with the primary series of IXIARO (Study 5). Subjects with PRNT titers <1:10 at 11 months after completion of the primary series received a booster dose of IXIARO 11 months later (22 months after completion of the primary series). Among 27 subjects with available immunogenicity data at 4 weeks after the booster dose, the proportion of subjects with PRNT titer u22651:10 was 100% [95% CI 87.5, 100.0], and the GMT was 2536.7 [95% CI 1467.7, 4384.4].
Concomitant Administration of IXIARO and Hepatitis A Vaccine, HAVRIX in Adults
The concomitant use of IXIARO with inactivated Hepatitis A Virus vaccine (HAVRIX) was evaluated in a randomized, controlled, singleu2011blind clinical trial including 192 healthy adults 18 to 61 years of age. Subjects were divided into three treatment groups: Group A (N=62) received IXIARO (Day 0 and 28) + HAVRIX (Day 0); Group B (N=65) received IXIARO (Day 0 and 28) + control (0.5 mL phosphate buffered saline with 0.1% aluminum hydroxide by intramuscular injection on Day 0); Group C (N=65) received HAVRIX (Day 0) + control (Day 0 and 28). Anti-JEV GMT at Day 56 in Group A met non-inferiority criteria compared to anti-JEV GMT at Day 56 in Group B. In addition, anti-HAV GMT at Day 28 in Group A met non-inferiority criteria compared to anti-HAV GMT at Day 28 in Group C. Therefore, concomitant administration of IXIARO and HAVRIX did not adversely affect immunogenicity compared to administration of either vaccine individually. Safety results regarding co-administration of IXIARO with HAVRIX are summarized in .
Delayed Completion of Primary Immunization in Adults
The immunogenicity of a second dose of the primary series administered 11 months after dose 1 was assessed in 100 adults in a study investigating persistence of immunity following vaccination with different dose-schedules of IXIARO (Study 5). Four weeks after this delayed second dose, 99.0% of subjects (99/100) had a PRNT titer u22651:10 (GMT 504.3 [95% CI: 367.3, 692.3]). One year later, 88.5% of subjects (85/96) had a PRNT titer u22651:10 (GMT 121.0 [95% CI: 87.4, 167.6]).

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Patient Information about
IXIARO (pronounced u201cu012dk-su0113-ah-ru014du201d)
Generic name: Japanese encephalitis vaccine, inactivated, adsorbed
Read this information about IXIARO before you are vaccinated. If you have any questions about IXIARO after reading this leaflet, ask your health care provider. This leaflet does not take the place of talking with your health care professional about IXIARO. Only your health care provider can decide if IXIARO is right for you.
What is IXIARO and how does it work?
What is Japanese encephalitis virus (JEV) and what is the disease caused by JEV?
Japanese encephalitis (JE) is caused by the Japanese encephalitis virus, JEV, which is mainly found in Asia. JEV is transmitted to humans by mosquitoes that have bitten an infected animal (like pigs). Many infected people develop mild symptoms or no symptoms at all. In people who develop severe disease, JE usually starts as a flu-like illness, with fever, chills, tiredness, headache, nausea, and vomiting. Confusion and agitation also occur in the early stage. JE causes death in one out of every three people with overt encephalitis. One out of two survivors develops permanent brain damage. JE acquired during pregnancy may cause intrauterine infection and miscarriage. u00a0
Who is at risk for Japanese encephalitis?
Who should not get IXIARO?
You should not get IXIARO if you:
IXIARO is not approved for use in infants below the age of 2 months.
What should I tell my health care professional before I am vaccinated with IXIARO?
It is very important to tell your health care provider if you:
How is IXIARO given?
IXIARO is given as an injection in the upper arm muscle in individuals 3 years of age and older. Infants 2 to 11 months of age are given the vaccine into the thigh.u00a0 Children 12 to 35 months of age may be given the vaccine into the arm muscle (if the muscle is large enough) or into the thigh.
You will get a total of 2 doses of the vaccine. Ideally, the doses are given as:
Make sure that you get both doses. If you miss the second dose, your health care provider will decide when to give the missed dose. Be aware that protection is not reliable until 1 week after you receive the second dose of IXIARO.
Adults 18 years of age and older: if the second dose was administered more than 1 year ago, you should consult your health care provider on the need for a booster dose of IXIARO prior to potential re-exposure to JEV.
What are the possible side effects of IXIARO?
The most common side effects in adolescents >12 years of age and adults are headache, muscle pain and injection site reactions (e.g., pain, swelling, tenderness, redness). Nausea, skin rash, fatigue, flu-like illness, fever, irritability and loss of appetite may also occur.u00a0
The most common side effects in children below the age of 12 years are fever, irritability, diarrhea, vomiting, loss of appetite, injection site pain and injection site redness.
Contact your health care provider right away if you get any symptoms after receiving IXIARO that concern you.
Tell your health care provider if you have any of the following problems because these may be signs of an allergic reaction:
What are the ingredients of IXIARO?
Active Ingredient:u00a0 purified components of inactivated Japanese encephalitis virus (JEV).
Inactive Ingredients:u00a0 aluminum hydroxide and phosphate buffered saline (sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate).
Minute amounts of other substances remain in the vaccine as a result of the manufacturing process.u00a0 Refer to the package insert for a complete list.
What else should I know about IXIARO?
This leaflet is a summary of information about IXIARO. If you would like more information, please talk to your health care professional.U.S.and international agencies (such as cdc.gov and who.int) also provide additional information about JEV and related travel advisories.
Issued March 2017
License Holder:
Valneva Austria GmbH, Vienna, Austria
Manufacturer:
Valneva Scotland Ltd., Livingston, UK
and
Distributed by
Intercell USA, Inc.Gaithersburg, MD 20878USA

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Japanese Encephalitis Vaccine, Inactivated, Adsorbed (Ixiaro)

Trade Name : IXIARO

INJECTION, SUSPENSION, VACCINE

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Japanese Encephalitis Vaccine, Inactivated, Adsorbed (Ixiaro)

Trade Name : IXIARO

INJECTION, SUSPENSION, VACCINE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

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