Active substance
Levonorgestrel
- SFDA 6
- US FDA 32
- Health Canada 6
- US price lines 1
- NHS prices 5
- WHO EML 2
- Safety 22
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| MICROLUT 0.03MG-TAB COATED TAB. | 0.03 mg | Coated tablet · Oral use | 35 Blister | SAR 14.55 | NCE · Prescription | BAYER AG | Valid |
| MIRENA 52 MG INTRAUTERINE DELIVERY SYSTEM (IUS) | 52 mg | Intrauterine delivery system · Vaginal use | 1 Box | SAR 379.60 | NCE · Prescription | BAYER OY | Valid |
| NAVELA 1.5 MG TABLET | 1.5 mg | Tablet · Oral use | 1 Blister | SAR 38.55 | NCE · OTC | EXELTIS GERMANY GmbH | Valid |
| POSTINOR-2 | 0.75 mg | Tablet · Oral use | 2 Blister | SAR 38.55 | Generic · OTC | AJA PHARMACEUTICAL INDUSTRIES | Valid |
| MICROLUT 0.03MG-TAB COATED TAB. | 0.03 mg | Coated tablet · Oral use | 35 Blister | SAR 14.55 | NCE · Prescription | BAYER PHARMA AG | Withdrawn by MAH · Not Marketed |
| POSTINOR-2 | 0.75 mg | Tablet · Oral use | 2 Blister | SAR 38.55 | Generic · Prescription | GEDEON RICHTER | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
CONTRACEPTION; ENDOMETRIOSIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MIRENA | 52MG | system · intrauterine | BAYER HLTHCARE | Prescription | 6 Dec 2000 |
| PLAN B ONE-STEP | 1.5MG | tablet · oral | FDN CONSUMER | Over-the-counter | 10 Jul 2009 |
| SKYLA | 13.5MG | system · intrauterine | BAYER HLTHCARE | Prescription | 9 Jan 2013 |
| LEVONORGESTREL | 0.75MG | tablet · oral | LUPIN LTD | Over-the-counter | 23 Jan 2013 |
| LEVONORGESTREL | 1.5MG | tablet · oral | NOVEL LABS INC | Over-the-counter | 22 Feb 2013 |
| FALLBACK SOLO | 1.5MG | tablet · oral | LUPIN | Over-the-counter | 19 Jun 2014 |
| LEVONORGESTREL | 1.5MG | tablet · oral | PERRIGO R AND D | Over-the-counter | 20 Aug 2014 |
| OPCICON ONE-STEP | 1.5MG | tablet · oral | SUN PHARM | Over-the-counter | 11 Sep 2014 |
| LEVONORGESTREL | 1.5MG | tablet · oral | XIROMED | Over-the-counter | 31 Oct 2014 |
| LILETTA | 52MG | system · intrauterine | MEDICINES360 | Prescription | 26 Feb 2015 |
| LEVONORGESTREL | 1.5MG | tablet · oral | NAARI PTE | Over-the-counter | 29 May 2015 |
| ATHENTIA NEXT | 1.5MG | tablet · oral | AUROBINDO PHARMA | Over-the-counter | 8 Dec 2015 |
| HER STYLE | 1.5MG | tablet · oral | NOVAST LABS | Over-the-counter | 11 Mar 2016 |
| LEVONORGESTREL | 1.5MG | tablet · oral | GLENMARK PHARMS LTD | Over-the-counter | 25 Mar 2016 |
| KYLEENA | 19.5MG | system · intrauterine | BAYER HLTHCARE | Prescription | 16 Sep 2016 |
| LEVONORGESTREL | 1.5MG | tablet · oral | LABORATOIRE HRA | Over-the-counter | 3 Jul 2018 |
| LEVONORGESTREL | 1.5MG | tablet · oral | XIROMED | Over-the-counter | 18 Sep 2018 |
| LEVONORGESTREL | 1.5MG | tablet · oral | NAARI PTE | Over-the-counter | 2 May 2019 |
| LEVONORGESTREL | 1.5MG | tablet · oral | ANNORA PHARMA | Over-the-counter | 30 Sep 2025 |
| NORPLANT | 36MG/IMPLANT | implant · implantation | POPULATION COUNCIL | Discontinued | 10 Dec 1990 |
| NORPLANT SYSTEM IN PLASTIC CONTAINER | 36MG/IMPLANT | implant · implantation | WYETH PHARMS INC | Discontinued | 10 Dec 1990 |
| LEVONORGESTREL | 75MG/IMPLANT | implant · implantation | WYETH PHARMS INC | Discontinued | 15 Aug 1996 |
| JADELLE | 75MG/IMPLANT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | implant · implantation | POPULATION COUNCIL | Discontinued | 1 Nov 1996 |
| PLAN B | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | FDN CONSUMER | Discontinued | 28 Jul 1999 |
| LEVONORGESTREL | 0.75MG | tablet · oral | WATSON LABS | Discontinued | 24 Jun 2009 |
7 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| BACKUP PLAN ONESTEP | 02433532 | 1.5 MG | TABLET · ORAL | APOTEX INC |
| CONTINGENCY ONE | 02425009 | 1.5 MG | TABLET · ORAL | SENADOR LABORATORIES PRIVATE LIMITED |
| KYLEENA | 02459523 | 19.5 MG | INSERT (EXTENDED-RELEASE) · INTRAUTERINE | BAYER INC |
| MIRENA | 02243005 | 52 MG | INSERT (EXTENDED-RELEASE) · INTRAUTERINE | BAYER INC |
| MYSTEP | 02548461 | 1.5 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| PLAN B | 02293854 | 1.5 MG | TABLET · ORAL | FOUNDATION CONSUMER HEALTHCARE, LLC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | LEVONORGESTREL 1.5 MG TABLET | $6.33055 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Levonorgestrel 1.5mg tablets | £1.31 | 1 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Levonorgestrel 13.5mg intrauterine device | £69.22 | 1 device | 1 Oct 2026 |
| NHS Drug Tariff | Levonorgestrel 19.5mg intrauterine device | £76.00 | 1 device | 1 Oct 2026 |
| NHS Drug Tariff | Levonorgestrel 20micrograms/24hours intrauterine device | £88.00 | 1 device | 1 Oct 2026 |
| NHS Drug Tariff | Levonorgestrel 30microgram tablets | £0.92 | 35 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 22.1.1. Oral hormonal contraceptives · core
Contact with health services for postcoital contraception; Contact with health services for contraceptive management
Oral > Solid: 750 µg [2]; 1.5 mg [1] | Oral > Solid: 30 µg - 22.1.3. Intrauterine devices · core
Contact with health services for insertion of contraceptive device
Intrauterine system with reservoir containing 52 mg of levonorgestrel.
Safety signals and safety-related labeling changes
- US FDA 16 Jul 2024 ALESSE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 15 Feb 2024 CLIMARA PRO — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 29 Jun 2023 LILETTA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 4 May 2023 SKYLA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 4 May 2023 KYLEENA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 27 Jan 2023 LOSEASONIQUE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 27 Jan 2023 SEASONALE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 27 Jan 2023 SEASONIQUE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 12 Aug 2022 MIRENA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 4 Aug 2022 QUARTETTE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 29 Apr 2022 LO/OVRAL FE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 29 Apr 2022 BALCOLTRA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 29 Apr 2022 NORDETTE-21 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 29 Apr 2022 NORDETTE-28 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 29 Apr 2022 TRIPHASIL-21 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
Combinations containing Levonorgestrel
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.