Rivastigmine (Rivastigmine)

Trade Name : Rivastigmine

Mylan Pharmaceuticals Inc.

PATCH

Strength 4.6 mg/24h

RIVASTIGMINE Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]

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

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Rivastigmine (Rivastigmine) which is also known as Rivastigmine and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 4.6 mg/24h per ml. Read more

Rivastigmine (Rivastigmine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of:

No data

2.1n- 2.4
Initial Dose:
Dose Titration (n- ):
Mild-to-Moderate Alzheimeru2019s Disease and Parkinsonu2019s Disease Dementia:
Severe Alzheimeru2019s Disease:
Arrayn- Array

Rivastigmine Transdermal System is available as 4.6 mg/24 hours, 9.5 mg/24 hours or 13.3u00a0mg/24 hours of rivastigmine.
Transdermal system:
3

Rivastigmine transdermal system is contraindicated in patients with:
Isolated cases of generalized skin reactions have been described in postmarketing experience .

4n- 6.2

No data

Gastrointestinal Adverse Reactions:

The following adverse reactions are described below and elsewhere in the labeling:
Most common adverse reactions (less than 5% and higher than with placebo): Nausea, vomiting, and diarrhea. ()
To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Concomitant use with metoclopramide, beta-blockers, or cholinomimetics and anticholinergic medications is not recommended. (, , )n

No data

Overdose with rivastigmine transdermal system has been reported in the postmarketing setting . Overdoses have occurred from application of more than one transdermal system at one time and not removing the previous dayu2019s transdermal system before applying a new transdermal system. The symptoms reported in these overdose cases are similar to those seen in cases of overdose associated with rivastigmine oral formulations.
Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug. As rivastigmine has a plasma half-life of about 3.4 hours after transdermal system administration and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose the transdermal system should be immediately removed and no further transdermal system should be applied for the next 24 hours.
As in any case of overdose, general supportive measures should be utilized.
Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterized by severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved. Atypical responses in blood pressure and heart rate have been reported with other drugs that increase cholinergic activity when coadministered with quaternary anticholinergics such as glycopyrrolate. Additional symptoms associated with rivastigmine overdose are diarrhea, abdominal pain, dizziness, tremor, headache, somnolence, confusional state, hyperhidrosis, hypertension, hallucinations and malaise. Due to the short plasma elimination half-life of rivastigmine after transdermal system administration, dialysis (hemodialysis, peritoneal dialysis, or hemofiltration) would not be clinically indicated in the event of an overdose.
In overdose accompanied by severe nausea and vomiting, the use of antiemetics should be considered. A fatal outcome has rarely been reported with rivastigmine overdose.

Rivastigmine transdermal system contains rivastigmine, a reversible cholinesterase inhibitor known chemically as ()-3-[1-(Dimethylamino) ethyl]phenyl ethyl(methyl)carbamate. It has a molecular formula of CHNO as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine, USP is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate.
The distribution coefficient at 37u00b0C in n-octanol/phosphate buffer solution pH 7 is 4.27.
Rivastigmine transdermal system is for transdermal administration. The transdermal system is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and slit protective release liner (see Figure 1). The release liner is removed and discarded prior to use.
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Excipients within the formulation include acrylic adhesive, dimethicone, poly(butylmethacrylate, methylmethacrylate), silicone adhesive, and flexible polymer backing film printed with brown ink. The brown ink contains acrylic polymers, carbon black, iron oxides (yellow and red), polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, and sodium dioctyl sulfosuccinate.
Rivastigmine transdermal systems are packaged with an additional piece of protective film below the system within each pouch. This piece of protective film is removed and discarded at the time of use.

No data

No data

The effectiveness of the rivastigmine transdermal system in dementia of the Alzheimeru2019s type and dementia associated with Parkinsonu2019s disease was based on the results of 3 controlled trials of rivastigmine transdermal system in patients with Alzheimeru2019s disease (Studies 1, 2, and 3) (see below); 3 controlled trials of oral rivastigmine in patients with dementia of the Alzheimeru2019s type; and 1 controlled trial of oral rivastigmine in patients with dementia associated with Parkinsonu2019s disease. See the prescribing information for oral rivastigmine for details of the four studies of oral rivastigmine.
Arrayn- International 24-Week Study of Rivastigmine Transdermal System in Dementia of the Alzheimeru2019s Type (Study 1):
The effectiveness of the rivastigmine transdermal system was evaluated in Study 1 using a dual outcome assessment strategy, evaluating for changes in both cognitive performance and overall clinical effect.
The ability of the rivastigmine transdermal system to improve cognitive performance was assessed with the cognitive subscale of the Alzheimeru2019s Disease Assessment Scale (ADAS-Cog), a multi-item instrument that has been extensively validated in longitudinal cohorts of Alzheimeru2019s-disease patients. The ADAS-Cog examines selected aspects of cognitive performance including elements of memory, orientation, attention, reasoning, language, and praxis. The ADAS-Cog scoring range is from 0 to 70, with higher scores indicating greater cognitive impairment. Elderly normal adults may score as low as 0 or 1, but it is not unusual for non-demented adults to score slightly higher.
The ability of the rivastigmine transdermal system to produce an overall clinical effect was assessed using the Alzheimeru2019s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC). The ADCS-CGIC is a more standardized form of the Clinician's Interview-Based Impression of Change-Plus (CIBIC-Plus) and is also scored as a 7-point categorical rating; scores range from 1, indicating u201cmarkedly improved,u201d to 4, indicating u201cno change,u201d to 7, indicating u201cmarked worsening.u201d
In Study 1, 1,195 patients were randomized to 1 of the following 4 treatments: rivastigmine transdermal system 9.5 mg/24 hours, rivastigmine transdermal system 17.4 mg/24 hours, rivastigmine capsules in a dose of 6 mg twice daily, or placebo. This 24-week study was divided into a 16-week titration phase followed by an 8-week maintenance phase. In the active treatment arms of this study, doses below the target dose were permitted during the maintenance phase in the event of poor tolerability.
Figure 3 illustrates the time course for the change from baseline in ADAS-Cog scores for all 4 treatment groups over the 24-week study. At 24 weeks, the mean differences in the ADAS-Cog change scores for the rivastigmine-treated patients compared to the patients on placebo, were 1.8, 2.9, and 1.8 units for the rivastigmine transdermal system 9.5 mg/24 hours, rivastigmine transdermal system 17.4 mg/24 hours, and rivastigmine capsule 6 mg twice daily groups, respectively. The difference between each of these groups and placebo was statistically significant. Although a slight improvement was observed with the 17.4 mg/24 hours transdermal system compared to the 9.5 mg/24 hours transdermal system on this outcome measure, no meaningful difference between the two was seen on the global evaluation (see Figure 4).
Figure 4 presents the distribution of patientsu2019 scores on the ADCS-CGIC for all 4 treatment groups. At 24 weeks, the mean difference in the ADCS-CGIC scores for the comparison of patients in each of the rivastigmine-treated groups with the patients on placebo was 0.2 units. The difference between each of these groups and placebo was statistically significant.
International 48-Week Study of Rivastigmine Transdermal System in Dementia of the Alzheimeru2019s Type (Study 2):
Alzheimeru2019s disease patients who received 24 to 48 weeks open-label treatment with rivastigmine transdermal system 9.5 mg/24 hours and who demonstrated functional and cognitive decline were randomized into treatment with either rivastigmine transdermal system 9.5 mg/24 hours or rivastigmine transdermal system 13.3 mg/24 hours in a 48-week, double-blind treatment phase. Functional decline was assessed by the investigator and cognitive decline was defined as a decrease in the MMSE score of greater than or equal to 2 points from the previous visit or a decrease of greater than or equal to 3 points from baseline.
Study 2 was designed to compare the efficacy of rivastigmine transdermal system 13.3 mg/24 hours versus that of rivastigmine transdermal system 9.5 mg/24 hours during the 48-week, double-blind treatment phase.
The ability of the rivastigmine transdermal system 13.3 mg/24 hours to improve cognitive performance over that provided by the rivastigmine transdermal system 9.5 mg/24 hours was assessed by the cognitive subscale of the Alzheimeru2019s Disease Assessment Scale (ADAS-Cog) .
The ability of the rivastigmine transdermal system 13.3 mg/24 hours to improve overall function versus that provided by rivastigmine transdermal system 9.5 mg/24 hours was assessed by the instrumental subscale of the Alzheimeru2019s Disease Cooperative Study Activities of Daily Living (ADCS-IADL). The ADCS-IADL subscale is composed of items 7 to 23 of the caregiver-based ADCS-ADL scale. The ADCS-IADL assesses activities such as those necessary for communicating and interacting with other people, maintaining a household, and conducting hobbies and interests. A sum score is calculated by adding the scores of the individual items and can range from 0 to 56, with higher scores indicating less impairment.
Out of a total of 1,584 patients enrolled in the initial open-label phase of the study, 567 patients were classified as decliners and were randomized into the 48-week double-blind treatment phase of the study. Two hundred eighty-seven (287) patients entered the 9.5 mg/24 hours rivastigmine transdermal system treatment group and 280 patients entered the 13.3 mg/24 hours rivastigmine transdermal system treatment group.
Figure 5 illustrates the time course for the mean change from double-blind baseline in ADCS-IADL scores for each treatment group over the course of the 48-week treatment phase of the study. Decline in the mean ADCS-IADL score from the double-blind baseline for the Intent to Treatu2013Last Observation Carried Forward (ITT-LOCF) analysis was less at each timepoint in the 13.3 mg/24 hour rivastigmine transdermal system treatment group than in the 9.5 mg/24 hours rivastigmine transdermal system treatment group. The 13.3 mg/24 hours dose was statistically significantly superior to the 9.5 mg/24 hours dose at weeks 16, 24, 32, and 48 (primary endpoint).
Figure 6 illustrates the time course for the mean change from double-blind baseline in ADAS-Cog scores for both treatment groups over the 48-week treatment phase. The between-treatment group difference for rivastigmine transdermal system 13.3 mg/24 hours versus rivastigmine transdermal system 9.5 mg/24 hours was nominally statistically significant at week 24 (p = 0.027), but not at week 48 (p = 0.227), which was the primary endpoint.
u00a0
Arrayn- 24-Week United States Study with Rivastigmine Transdermal System in Severe Alzheimeru2019s Disease (Study 3):
The study was designed to compare the efficacy of rivastigmine transdermal system 13.3 mg/24 hours versus that of rivastigmine transdermal system 4.6 mg/24 hours during the 24-week double-blind treatment phase.
The ability of the 13.3 mg/24 hours rivastigmine transdermal system to improve cognitive performance versus that provided by the 4.6 mg/24 hours rivastigmine transdermal system was assessed with the Severe Impairment Battery (SIB) which uses a validated 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced AD patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuospatial ability, construction, and orienting to name. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability.
The ability of the 13.3 mg/24 hours rivastigmine transdermal system to improve overall function versus that provided by the 4.6 mg/24 hours rivastigmine transdermal system was assessed with the Alzheimeru2019s Disease Cooperative Study-Activities of Daily Livingu2013Severe Impairment Version (ADCS-ADL-SIV) which is a caregiver-based ADL scale composed of 19 items developed for use in clinical studies of dementia. It is designed to assess the patientu2019s performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. A sum score is calculated by adding the scores of the individual items and can range from 0 to 54, with higher scores indicating less functional impairment.
In this study, 716 patients were randomized into one of the following treatments: rivastigmine transdermal system 13.3 mg/24 hours or rivastigmine transdermal system 4.6 mg/24 hours in a 1:1 ratio. This 24-week study was divided into an 8-week titration phase followed by a 16-week maintenance phase. In the active treatment arms of this study, temporary dose adjustments below the target dose were permitted during the titration and maintenance phase in the event of poor tolerability.
Figure 7 illustrates the time course for the mean change from baseline SIB scores for each treatment group over the course of the 24-week treatment phase of the study. Decline in the mean SIB score from the baseline for the Modified Full Analysis Set (MFAS)-Last Observation Carried Forward (LOCF) analysis was less at each timepoint in the 13.3 mg/24 hours rivastigmine transdermal system treatment group than in the 4.6 mg/24 hours rivastigmine transdermal system treatment group. The 13.3 mg/24 hours dose was statistically significantly superior to the 4.6u00a0mg/24 hours dose at weeks 16 and 24 (primary endpoint).
Figure 8 illustrates the time course for the mean change from baseline in ADCS-ADL-SIV scores for each treatment group over the course of the 24-week treatment phase of the study. Decline in the mean ADCS-ADLSIV score from baseline for the MFAS-LOCF analysis was less at each timepoint in the 13.3 mg/24 hours rivastigmine transdermal system treatment group than in the 4.6 mg/24 hours rivastigmine transdermal system treatment group. The 13.3 mg/24 hours dose was statistically significantly superior to the 4.6 mg/24 hours dose at weeks 16 and 24 (primary endpoint).
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Rivastigmine Transdermal System is available as 4.6 mg/24 hours, 9.5u00a0mg/24u00a0hours or 13.3u00a0mg/24 hours of rivastigmine.
Arrayn- Rivastigmine Transdermal System 4.6 mg/24 hours
Each transdermal system of 5 cm contains 9 mg rivastigmine, USP base with release rate of 4.6 mg/24 hours. The round transdermal system consists of a peach-colored backing randomly printed with u201cRivastigmine 4.6 mg/24 hoursu201d in brown ink, a translucent adhesive layer, and a clear to slightly hazy oversized release liner that is slit and has small dimples surrounding the transdermal system. Each transdermal system also has a clear to slightly hazy oversized underlay and is contained in a square pouch. The pouch is imprinted with lot number and expiration date. They are available as follows:
NDC 0378-9070-93carton containing 30 transdermal systems
Arrayn- Rivastigmine Transdermal System 9.5 mg/24 hours
Each transdermal system of 10 cm contains 18 mg rivastigmine, USP base with release rate of 9.5 mg/24 hours. The round transdermal system consists of a peach-colored backing randomly printed with u201cRivastigmine 9.5 mg/24 hoursu201d in brown ink, a translucent adhesive layer, and a clear to slightly hazy oversized release liner that is slit and has small dimples surrounding the transdermal system. Each transdermal system also has a clear to slightly hazy oversized underlay and is contained in a square pouch. The pouch is imprinted with lot number and expiration date. They are available as follows:
NDC 0378-9071-93carton containing 30 transdermal systems
Arrayn- Rivastigmine Transdermal System 13.3 mg/24 hours
Each transdermal system of 15 cm contains 27 mg rivastigmine, USP base with release rate of 13.3 mg/24 hours. The round transdermal system consists of a peach-colored backing randomly printed with u201cRivastigmine 13.3 mg/24 hoursu201d in brown ink, a translucent adhesive layer, and a clear to slightly hazy oversized release liner that is slit and has small dimples surrounding the transdermal system. Each transdermal system also has a clear to slightly hazy oversized underlay and is contained in a square pouch. The pouch is imprinted with lot number and expiration date. They are available as follows:
NDC 0378-9072-93carton containing 30 transdermal systems
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling ().
Arrayn- [see , ]
Instruct patients or caregivers to avoid exposure of the transdermal system to external heat sources (excessive sunlight, saunas, solariums) for long periods of time.
Instruct patients who have missed a dose to apply a new transdermal system immediately. They may apply the next transdermal system at the usual time the next day. Instruct patients to not apply 2 transdermal systems to make up for 1 missed.
Inform the patient or caregiver to contact the physician for retitration instructions if treatment has been interrupted.
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Arrayn- Pregnancy:

This Patient Information has been approved by the U.S. Food and Drug Administration.
Instructions for Usen- Rivastigmine Transdermal Systemn- (rivu02ba a stigu02b9 meen)
You will need the following supplies (See Figure A):
Rivastigmine transdermal system is supplied in cartons containing 30 transdermal systems (See Figure A)
Using rivastigmine transdermal system:
Step 1. Choose an area to apply the rivastigmine transdermal system (See Figure B).
The diagram represents areas on the body where rivastigmine transdermal system may be applied. Only 1 transdermal system should be worn at a time. Do not apply multiple transdermal systems to the body.
Step 2. Remove the rivastigmine transdermal system from the pouch (See Figure C).
Carefully cut the pouch along the dotted line to open and remove the rivastigmine transdermal system. Save the pouch for later use. Rivastigmine transdermal systems are packaged with an additional piece of protective film below the system within each pouch. This piece of protective film should be removed and discarded at the time of use.
Step 3. Remove 1 side of the adhesive liner (See Figure D).
Step 4. Apply the rivastigmine transdermal system to your skin (See Figure E).
Step 5: Wash your hands with soap and water right away.
Note:
Removing your rivastigmine transdermal system:
Step 6. Remove the rivastigmine transdermal system from the skin (See Figure G).
Throwing away the used rivastigmine transdermal system:
Step 7. Throw away the used rivastigmine transdermal system (See Figure H).
Step 8: Wash your hands with soap and water right away.
This Instructions for Use have been approved by the U.S. Food and Drug Administration.
Manufactured for:n n Morgantown, WV 26505 U.S.A.
Revised: 4/2019RIVA:R4

Contains 30 Systemsn- Rx only
NDC 0378-9070-93
Rivastigminen- Transdermal Systemn- Each System Deliversn- 4.6 mg/24 hours
Each 5 cm system contains 9 mg rivastigmine, USP to provide 4.6 mg rivastigmine every 24 hours.
Keep out of the reach of children.
FOR TRANSDERMAL USE ONLY.
Inactive components:
Apply patch immediately after removal from pouch.
Do not store unpouched.
Do not use any patch that is damaged or shows signs of tampering.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
Dosage and Administration:
Mylan.com
Manufactured for:n Morgantown, WV 26505 U.S.A.
M9070:93:30C:R3
Discarding Rivastigminen- Transdermal System
Every 24 hours you should remove the old patch and apply a new patch.
For more information, call Mylan atn

Contains 30 Systemsn- Rx only
NDC 0378-9071-93
Rivastigminen- Transdermal Systemn- Each System Deliversn- 9.5 mg/24 hours
Each 10 cm system contains 18 mg rivastigmine, USP to provide 9.5 mg rivastigmine every 24 hours.
Keep out of the reach of children.
FOR TRANSDERMAL USE ONLY.
Inactive components:
Apply patch immediately after removal from pouch.
Do not store unpouched.
Do not use any patch that is damaged or shows signs of tampering.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
Dosage and Administration:
Mylan.com
Manufactured for:n Morgantown, WV 26505 U.S.A.
M9071:93:30C:R4
Discarding Rivastigminen- Transdermal System
Every 24 hours you should remove the old patch and apply a new patch.
For more information, call Mylan at n

Contains 30 Systemsn- Rx only
NDC 0378-9072-93
Rivastigminen- Transdermal Systemn- Each System Deliversn- 13.3 mg/24 hours
Each 15 cm system contains 27 mg rivastigmine, USP to provide 13.3 mg rivastigmine every 24 hours.
Keep out of the reach of children.
FOR TRANSDERMAL USE ONLY.
Inactive components:
Apply patch immediately after removal from pouch.
Do not store unpouched.
Do not use any patch that is damaged or shows signs of tampering.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
Dosage and Administration:
Mylan.com
Manufactured for:n Morgantown, WV 26505 U.S.A.
M9072:93:30C:R4
Discarding Rivastigmine Transdermal System
Every 24 hours you should remove the old patch and apply a new patch.
For more information, call Mylan atn

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Rivastigmine (Rivastigmine)

Trade Name : Rivastigmine

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Rivastigmine (Rivastigmine)

Trade Name : Rivastigmine

PATCH

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)

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Fluoxetine Hydrochloride (Fluoxetine)

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