Active substance
Milnacipran
- US FDA 6
- EMA 2
- US price lines 8
- Safety 9
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SAVELLA | 12.5MG; 25MG; 50MG; 100MG | tablet · oral | ABBVIE | Prescription | 14 Jan 2009 |
| MILNACIPRAN HYDROCHLORIDE | 12.5MG; 25MG; 50MG; 100MG | tablet · oral | BRECKENRIDGE | Prescription | 27 Jan 2016 |
| MILNACIPRAN HYDROCHLORIDE | 12.5MG; 25MG; 50MG; 100MG | tablet · oral | AMNEAL PHARMS | Prescription | 22 Apr 2016 |
| MILNACIPRAN HYDROCHLORIDE | 12.5MG; 25MG; 50MG; 100MG | tablet · oral | HETERO LABS LTD V | Prescription | 3 Oct 2024 |
| MILNACIPRAN HYDROCHLORIDE | 12.5MG; 25MG; 50MG; 100MG | tablet · oral | STRIDES PHARMA | Prescription | 15 Sep 2026 |
| MILNACIPRAN HYDROCHLORIDE | 12.5MG; 25MG; 50MG; 100MG | tablet · oral | MACLEODS PHARMS | Prescription | 15 Sep 2026 |
EMA European Union — centrally authorised medicines
Impulsor Pierre Fabre Medicament · Refused
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | MILNACIPRAN HCL 100 MG TABLET | $2.81889 | per EA | 23 Sep 2026 |
| US NADAC | MILNACIPRAN HCL 12.5 MG TABLET | $0.78243 | per EA | 23 Sep 2026 |
| US NADAC | MILNACIPRAN HCL 25 MG TABLET | $2.52611 | per EA | 23 Sep 2026 |
| US NADAC | MILNACIPRAN HCL 50 MG TABLET | $2.80179 | per EA | 23 Sep 2026 |
| US NADAC | SAVELLA 100 MG TABLET | $8.15054 | per EA | 23 Sep 2026 |
| US NADAC | SAVELLA 12.5 MG TABLET | $8.16401 | per EA | 23 Sep 2026 |
| US NADAC | SAVELLA 25 MG TABLET | $8.15605 | per EA | 23 Sep 2026 |
| US NADAC | SAVELLA 50 MG TABLET | $8.15866 | per EA | 23 Sep 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.
Safety signals and safety-related labeling changes
- US FDA 18 Aug 2023 SAVELLA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 29 Sep 2022 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: No - EMA PRAC 10 Mar 2022 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: No - EMA PRAC 1 Oct 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: Yes - EMA PRAC 11 Jun 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No - EMA PRAC 12 Mar 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No - EMA PRAC 16 May 2019 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: Yes - EMA PRAC 31 Oct 2018 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: No - EMA PRAC 6 Sep 2018 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: No
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.