Ecalta Pfizer Europe MA EEIG · Authorised · authorised 20 Sep 2007 · ATC J02AX06
Therapeutic indication (EMA)
Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years.
Active substance
Anidulafungin
- SFDA 4
- US FDA 2
- EMA 1
- Health Canada 1
- WHO EML 1
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Anidulafungin BOS | 100 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 406.80 | Generic · Prescription | Boston Oncology Arabia | Valid |
| ECALTA 100MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION | 100 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 612.55 | NCE · Prescription | PFIZER | Valid |
| Lectra | 100 mg | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 571.70 | Generic · Prescription | Med City Pharma | Valid |
| Safdola | 100 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 483.40 | Generic · Prescription | MS Pharma Saudi (MSPS) | Valid |
Indications — CHI Daman Drug Formulary
ANTIMICROBIAL PROPHYLAXIS IN CANCER PATIENTS; ENDOCARDITIS; INTRA-ABDOMINAL INFECTIONS; Invasive Candidiasis and Candidemia; OROPHARYNGEAL CANDIDIASIS; PERITONITIS, TERTIARY PERITONITIS, POST-OPERATIVE PERITONITIS, PERITONEAL DIALYSIS RELATED PERITONITIS; Pyogenic Arthritis
US FDA United States — FDA approvals (Drugs@FDA)
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| ERAXIS | 02330695 | 100 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | PFIZER CANADA ULC |
WHO WHO Model List of Essential Medicines (2025)
- 6.3. Antifungal medicines · complementary
Therapeutic equivalent to micafungin for Systemic or invasive candidosis
Safety signals and safety-related labeling changes
- US FDA 22 Sep 2020 ERAXIS — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.