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Norethisterone Acetate
Europe

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pharmacompass-2-2026-02-09

Norethisterone Acetate

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

28 API Suppliers, 12 USDMF, 4 CEP/COS, 1 JDMF, 4 EU WC, 5 NDC API, 13 Listed Suppliers, $ API Reference Price

28 API Suppliers
12 USDMF
4 CEP/COS
1 JDMF
4 EU WC
5 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

29 Drugs in Development

29 Drugs in Development

FINISHED DOSAGE FORMULATIONS

246 FDF Dossiers, 120 FDA Orange Book, 103 Europe, 7 Canada, 9 Australia, 7 Listed Dossiers

246 FDF Dossiers
120 FDA Orange Book
103 Europe
7 Canada
9 Australia
7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG, CAPSULE;ORAL - 0.02MG;1MG, TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR, TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;ORAL - 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A

TABLET;ORAL-28 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-21 - 0.03MG;1.5MG
TABLET;ORAL-21 - 0.03MG;1.5MG
TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG
CAPSULE;ORAL - 0.02MG;1MG
TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR
TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 1MG;0.5MG
TABLET;ORAL - 0.0025MG;0.5MG
TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 5 SPI Pharma, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 1 ACG Worldwide, 4 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 19 BASF, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 13 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 5 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

64 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 35 Direct Compression, 32 Granulation, 31 Disintegrants & Superdisintegrants, 25 Solubilizers, 23 Controlled & Modified Release, 21 Thickeners and Stabilizers, 20 Lubricants & Glidants, 16 Taste Masking, 15 Parenteral, 14 Film Formers & Plasticizers, 13 Co-Processed Excipients, 9 Emulsifying Agents, 9 Topical, 8 Chewable & Orodispersible Aids, 8 API Stability Enhancers, 6 Rheology Modifiers, 6 Surfactant & Foaming Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 2 Coloring Agents

64 Fillers, Diluents & Binders
49 Coating Systems & Additives
35 Direct Compression
32 Granulation
31 Disintegrants & Superdisintegrants
25 Solubilizers
23 Controlled & Modified Release
21 Thickeners and Stabilizers
20 Lubricants & Glidants
16 Taste Masking
15 Parenteral
14 Film Formers & Plasticizers
13 Co-Processed Excipients
9 Emulsifying Agents
9 Topical
8 Chewable & Orodispersible Aids
8 API Stability Enhancers
6 Rheology Modifiers
6 Surfactant & Foaming Agents
5 Empty Capsules
4 Vegetarian Capsules
2 Coloring Agents

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 47 News #PharmaBuzz

2 Data Compilation #PharmaFlow
47 News #PharmaBuzz

GLOBAL SALES INFORMATION

13 US Medicaid Prescriptions, 3 Regulatory FDF Prices, 7 Annual Reports

13 US Medicaid Prescriptions
3 Regulatory FDF Prices
7 Annual Reports

MARKET PLACE

7 APIs

7 APIs

PATENTS & EXCLUSIVITIES

10 US Patents, 4 US Exclusivities, 1 Health Canada Patents

10 US Patents
4 US Exclusivities
1 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 1 Others

2 EDQM
1 USP
1 Others

$ API Ref.Price (USD/KG) : 1,173 Xls

Filters

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FILTER :

filter Applicant Reset all filters

103 All

01 32Care4 Aps

02 12care4 ApS

03 3Abacus Medicine A/S

04 2Bayer Hispania Sl

05 1Bexal Farmaceutica Sa

06 2Cross Pharma Ab

07 1Dr. Kade Pharmazeutisce Fabrik Gmbh

08 2Dr. Kade Pharmazeutische Fabrik Gmbh

09 1Dr. Kade Pharmazeuyische Fabrik GmbH

10 1Ebb Medical Ab

11 2Exeltis Healthcare, S.L.

12 1Gedeon Richter (Switzerland) Ag

13 3Gedeon Richter Plc

14 4Gedeon Richter Plc.

15 4Isdin Sa

16 2Ivax Scandinavia Ab

17 2Labatec Pharma Sa

18 4Medartuum Ab

19 1NOVO NORDISK FARMACEUTICI SpA

20 1Novartis Pharmaceuticals Sa

21 3Novartis Sweden Ab

22 14Novo Nordisk A/S

23 1Novo Nordisk Pharma

24 4Novo Nordisk Pharma Ag

25 1NovoNordisk A/S

26 2Orifarm A/S

27 3Orifarm AS

28 15Orifarm Ab

29 1Paranova Denmark A/S

30 6Paranova Pharmaceuticals Ab

31 1Sandoz - Copenhagen

32 7Sandoz A/S

33 2Sandoz Pharmaceuticals Ag

34 2Theramex Ireland Limited

filter Active Ingredients Reset all filters

103 All

01 1Estradiol Hemihydrate; Estradiol Hemihydrate; Norethisterone Acetate

02 52Estradiol Hemihydrate; Norethisterone Acetate

03 2Estradiol Hemihydrate; Norethisterone Acetate; Relugolix

04 3Estradiol Valerate; Norethisteron Acetate

05 8Estradiol Valerate; Norethisterone Acetate

06 8Estradiol hemihydrate; Norethisterone acetate

07 1Estradiol valerate; Norethisterone acetate

08 1Estradiol; Norethindrone Acetate

09 15Estradiol; Norethisterone Acetate

10 1Estradiolhemihydrate; Norethisterone Acetate; Relugolix

11 2Norethisterone Acetate

12 1Norethisterone Acetate; Estradiol

13 7Relugoliks; Ã˜stradiolhemihydrat; Noretisteronacetat

14 1Relugolix; Estradiol; Norethisterone Acetate

filter Dosage Form Reset all filters

103 All

01 54Film Coated Tablet

02 16Tablet

03 32Transdermal Patch

04 1Blank

filter Country Reset all filters

103 All

01 17Denmark

02 1Italy

03 1Malta

04 16Norway

05 10Spain

06 49Sweden

07 9Switzerland

filter Brand Name Reset all filters

103 All

01 15Activelle

02 1Activelle Film-Coated

03 1Activelle Low

04 1Cliogest

05 1Cliovellan

06 10Cliovelle

07 1Conti system

08 1Duofemme Film-Coated Tablets.

09 16Estalis

10 5Estalis Sequence

11 1Estalis Sequidot

12 4Estracomb

13 1Evian

14 2Eviana

15 1Evo-Conti

16 1Evo-Sequi

17 2Femanor

18 2Kliogest

19 1Kliogest N

20 4Noresmea

21 1Norethisterone/Estrogen "2Care4"

22 4Novofem

23 2Primolut-Nor

24 11Ryeqo

25 1Sequence Of Five

26 1Sequi system

27 2Sequidot

28 4Trisequence

29 3Trisequens

30 2Trisequens Coated Tablets

31 1Trisequens N

Coral Drugs Norethisterone Acetate

List of Suppliers

Product Main Page

01

2Care4 Aps

ASPEN

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2Care4 Aps

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Regulatory Info : Deregistered

Registration Country : Sweden

Estradiol Hemihydrate; Norethisterone Acetate

Brand Name : Estalis

Dosage Form : Transdermal Patch

Dosage Strength : 50mcg/24hours;250mcg/24hours

Packaging :

Approval Date : 18/05/2016

Application Number : 20151013000069

Regulatory Info : Deregistered

Registration Country : Sweden

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02

2care4 ApS

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2care4 ApS

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Regulatory Info : Marketed

Registration Country : Norway

Relugoliks; Ã˜stradiolhemihydrat; Noretisteronacetat

Brand Name : Ryeqo

Dosage Form : Film Coated Tablet

Dosage Strength : 40mg; 1mg; 0.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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03

2Care4 Aps

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2Care4 Aps

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Digital Content

Regulatory Info : Prescription

Registration Country : Denmark

Estradiol Hemihydrate; Norethisterone Acetate

Brand Name : Trisequens

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 16-11-2017

Application Number : 28106011917

Regulatory Info : Prescription

Registration Country : Denmark

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04

2Care4 Aps

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2Care4 Aps

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Digital Content

Regulatory Info : Prescription

Registration Country : Denmark

Estradiol Valerate; Norethisteron Acetate

Brand Name : Norethisterone/Estrogen \"2Care4\"

Dosage Form : Tablet

Dosage Strength : 0.5mg; 1mg

Packaging :

Approval Date : 21-11-2016

Application Number : 28105847616

Regulatory Info : Prescription

Registration Country : Denmark

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05

Abacus Medicine A/S

ASPEN

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Abacus Medicine A/S

ASPEN

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Regulatory Info : Approved

Registration Country : Sweden

Estradiol Valerate; Norethisterone Acetate

Brand Name : Cliovelle

Dosage Form : Tablet

Dosage Strength : 1mg;0.5mg

Packaging :

Approval Date : 11/06/2024

Application Number : 20240308000157

Regulatory Info : Approved

Registration Country : Sweden

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06

Abacus Medicine A/S

ASPEN

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Abacus Medicine A/S

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Regulatory Info : Approved

Registration Country : Sweden

Estradiol Valerate; Norethisterone Acetate

Brand Name : Cliovelle

Dosage Form : Tablet

Dosage Strength : 1mg;0.5mg

Packaging :

Approval Date : 11/06/2024

Application Number : 20240308000164

Regulatory Info : Approved

Registration Country : Sweden

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07

Abacus Medicine A/S

ASPEN

Not Confirmed

Abacus Medicine A/S

ASPEN

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Regulatory Info : Prescription

Registration Country : Denmark

Estradiol Valerate; Norethisteron Acetate

Brand Name : Cliovelle

Dosage Form : Tablet

Dosage Strength : 0.5mg; 1mg

Packaging :

Approval Date : 15-01-2025

Application Number : 28107296924

Regulatory Info : Prescription

Registration Country : Denmark

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08

Bayer Hispania Sl

ASPEN

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Bayer Hispania Sl

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Regulatory Info : Cancelled

Registration Country : Spain

Norethisterone Acetate

Brand Name : Primolut-Nor

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date : 01-06-1967

Application Number : 44646

Regulatory Info : Cancelled

Registration Country : Spain

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09

Bayer Hispania Sl

ASPEN

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Bayer Hispania Sl

ASPEN

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Regulatory Info : Authorized

Registration Country : Spain

Norethisterone Acetate

Brand Name : Primolut-Nor

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date : 01-07-1964

Application Number : 39927

Regulatory Info : Authorized

Registration Country : Spain

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10

Bexal Farmaceutica Sa

Country

ASPEN

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Bexal Farmaceutica Sa

Country

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Regulatory Info : Suspended

Registration Country : Spain

Estradiol Hemihydrate; Estradiol Hemihydrate; Norethisterone Acetate

Brand Name : Estalis Sequidot

Dosage Form : Transdermal Patch

Dosage Strength :

Packaging :

Approval Date : 18-04-2008

Application Number : 69746

Regulatory Info : Suspended

Registration Country : Spain

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