“We use cookies on this website to enhance your user experience and to personalise content. By clicking any link or continuing to use our Website you agree to our cookies as per our Privacy Policy. Read More” Ok, I agree

Estradiol And Norethindrone Acetate (Mimvey)

Trade Name : Mimvey

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 1.5 mg/1mg/1

ESTRADIOL; NORETHINDRONE ACETATE Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [CS],Progestin [EPC]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 Estradiol And Norethindrone Acetate (Mimvey) which is also known as Mimvey and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 1; .5 mg/1; mg/1 per ml. Read more

Estradiol And Norethindrone Acetate (Mimvey) 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

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more

About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • Warnings and Precautions, Malignant Neoplasms () 11/2017
  • Arrayn- Estrogen Plus Progestin Therapy
  • Cardiovascular Disorders and Probable Dementia
  • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia .
  • The Womenu2019s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogen (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo .
  • The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women .
  • Breast Cancer
  • The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer .
  • In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins.
  • Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
  • Arrayn- Estrogen-Alone Therapy
  • Endometrial Cancer
  • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding .
  • Cardiovascular Disorders and Probable Dementia
  • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia .
  • The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg)-alone, relative to placebo .
  • The WHIMS estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women .
  • In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.
  • Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment.
  • WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER AND PROBABLE DEMENTIA
  • See full prescribing information for complete boxed warning
  • Estrogen Plus Progestin Therapy
  • Estrogen-Alone Therapy
  • Mimvey and Mimvey Lo are an estrogen and progestin combination indicated in a woman with a uterus for:
  • Mimvey 1 mg/0.5 mg and Mimvey Lo 0.5 mg/0.1 mg are indicated in a woman with a uterus for:
  • Mimvey 1 mg/0.5 mg is also indicated in a woman with a uterus for:
  • Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
  • One tablet to be taken once daily ()
  • Mimvey tablets are available in two strengths:
  • Mimvey (estradiol and norethindrone acetate) 1 mg/0.5 mg tablet ()
  • Mimvey Lo (estradiol and norethindrone acetate) 0.5 mg/0.1 mg tablet ()
  • Mimvey and Mimvey Lo are contraindicated in women with any of the following conditions:
  • Undiagnosed abnormal genital bleeding ()
  • Known, suspected, or history of breast cancer (, )
  • Known or suspected estrogen-dependent neoplasia (, )
  • Active DVT, PE, or history of these conditions (, )
  • Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (, )
  • Known anaphylactic reaction or angioedema or hypersensitivity to Mimvey or Mimvey Lo ()
  • Known liver impairment or disease (, )
  • Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders ()
  • Known or suspected pregnancy (, )
  • No data
  • Estrogens increase the risk of gall bladder disease ()
  • Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (, , , )
  • Monitor thyroid function in women on thyroid replacement therapy (, )
  • The following serious adverse reactions are discussed elsewhere in the labeling:
  • Most common adverse reactions (incidence u2265 5 percent) are back pain, headache, pain in the extremity, nausea, diarrhea, gastroenteritis, insomnia, emotional lability, upper respiratory tract infection, sinusitis, nasopharyngitis, weight increase, breast pain, post-menopausal bleeding, uterine fibroid vaginal hemorrhage, ovarian cyst, endometrial thickening, viral infection, moniliasis genital, and accidental injury. ()
  • Coadministration of estradiol with norethindrone acetate did not elicit any apparent influence on the pharmacokinetics of norethindrone acetate. Similarly, no relevant interaction of norethindrone acetate on the pharmacokinetics of estradiol was found within the NETA dose range investigated in a single dose study.
  • Estradiol
  • In-vitro
  • in-vivo
  • (Hypericum perforatum)
  • Norethindrone Acetate
  • Drugs or herbal products that induce or inhibit cytochrome P-450 enzymes, including CYP3A4, may decrease or increase the serum concentrations of norethindrone.
  • Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism ()
  • No data
  • Nursing Mothers: Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk ()
  • Geriatric Use: An increase risk of probable dementia in women over 65 years of age was reported in the Women's Health Initiative Memory ancillary studies of the Women's Health Initiative (, )
  • Overdosage of estrogen plus progestin may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of Mimvey and Mimvey Lo therapy with institution of appropriate symptomatic care.
  • Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol, USP and 0.5 mg of norethindrone acetate, USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, and titanium dioxide.
  • Mimvey Lo (estradiol and norethindrone acetate tablets USP) 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol, USP and 0.1 mg of norethindrone acetate, USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, corn starch, lactose monohydrate, and magnesium stearate.
  • Estradiol (E), is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)-triene-3, 17u03b2-diol hemihydrate. The structural formula of E is as follows:
  • Estradiol, USP
  • CHO, u00bd HO tM.W. 281.4
  • Norethindrone acetate (NETA), is a white or yellowish-white crystalline powder. Its chemical name is 17u03b2-acetoxy-19-nor-17u03b1-pregn-4-en-20-yn-3-one. The structural formula of NETA is as follows:
  • Norethindrone Acetate, USP
  • CHO tM.W. 340.5
  • No data
  • Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.
  • No data
  • No data
  • No data
  • See FDA-approved patient labeling (Patient Information)
  • Mimveyn
  • (estradiol and norethindrone acetate tablets, 1 mg/0.5 mg)
  • Mimvey Lo
  • (estradiol and norethindrone acetate tablets, 0.5 mg/0.1 mg)
  • Read this Patient Information before you start taking Mimvey or Mimvey Lo and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.
  • What are Mimvey and Mimvey Lo?
  • Mimvey and Mimvey Lo are a prescription medicine that contains two kinds of hormones, an estrogen and a progestin.
  • What are Mimvey and Mimvey Lo used for?
  • Mimvey and Mimvey Lo are used after menopause to:
  • Who should not take Mimvey or Mimvey Lo?
  • Do not take Mimvey or Mimvey Lo if you have had your uterus removed (hysterectomy)
  • Mimvey and Mimvey Lo contain a progestin to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not take Mimvey or Mimvey Lo.
  • Do not take Mimvey or Mimvey Lo if you:
  • What should I tell my healthcare provider before taking Mimvey or Mimvey Lo?
  • Before you take Mimvey or Mimvey Lo, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take,
  • How should I take Mimvey 1 mg/0.5 mg or Mimvey Lo 0.5 mg/0.1 mg?
  • What are the possible side effects of Mimvey and Mimvey Lo?
  • Side effects are grouped by how serious they are and how often they happen when you are treated.
  • Serious, but less common side effects include:
  • Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
  • Less serious, but common side effects include:
  • These are not all the possible side effects of Mimvey 1 mg/0.5 mg and Mimvey Lo 0.5 mg/0.1 mg. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or does not go away. You may report side effects to Teva at 1-888-838-2872 or to FDA at 1-800-FDA-1088.
  • What can I do to lower my chances of a serious side effect with Mimvey 1 mg/0.5 mg or Mimvey Lo 0.5 mg/0.1 mg?
  • Ask your healthcare provider for ways to lower your chances for getting heart disease.
  • How should I store Mimvey and Mimvey Lo?
  • Keep Mimvey and Mimvey Lo and all medicines out of the reach of children.
  • General information about the safe and effective use of Mimvey and Mimvey Lo
  • Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take Mimvey or Mimvey Lo for conditions for which it was not prescribed. Do not give Mimvey or Mimvey Lo to other people, even if they have the same symptoms you have. It may harm them.
  • This leaflet summarizes the most important information about Mimvey and Mimvey Lo. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your pharmacist or healthcare provider for information about Mimvey and Mimvey Lo that is written for health professionals.
  • For more information call 1-888-838-2872.
  • What are the ingredients in Mimvey and Mimvey Lo?
  • Active ingredient:
  • Inactive Ingredients:
  • The 1 mg/0.5 mg tablet also contains hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. E 11/2017
  • NDCn- 5455
  • 1 BLISTER CARD, 28 TABLETS
  • 28
  • DAY
  • REGIMEN
  • Arrayn- Mimvey u00ae
  • (estradiol and norethindrone
  • acetate tablets USP)
  • 1 mg/0.5 mg
  • Each white tablet contains 1 mg estradiol, USP and 0.5 mgnorethindrone acetate, USP.
  • Rx only
  • SHAPING
  • WOMENu2019S HEALTHn
  • TEVA

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Desogestrel And Ethinyl Estradiol (Emoquette)

Manufacturer: REMEDYREPACK INC.

Presentation: KIT

Strength:

Pack Size:

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

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

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET

Strength: 2.5; .025 mg/1; mg/1

Pack Size:

Fluoxetine Hydrochloride (Fluoxetine)

Fluoxetine Hydrochloride (Fluoxetine)

Manufacturer: REMEDYREPACK INC.

Presentation: CAPSULE

Strength: 40 mg/1

Pack Size:

Metoprolol Succinate (Metoprolol Succinate)

Metoprolol Succinate (Metoprolol Succinate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, EXTENDED RELEASE

Strength: 25 mg/1

Pack Size:

Losartan Potassium (Losartan Potassium)

Losartan Potassium (Losartan Potassium)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, FILM COATED

Strength: 25 mg/1

Pack Size:

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Get Price

Are you an existing customer or a vendor of GNH India? Log in here to

View your Transaction
COMPANY
SERVICES
QUICK LINKS
CONTACT US
Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

US Office Address:

GNH Pharmaceuticals USA LLC,
Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
TEL: +1 704 557 0412

Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.