Tacrolimus
Advagraf, Envarsus, Modigraf, Protopic · ATC code L04AD02
Brand names: Advagraf, Envarsus, Modigraf, Protopic, Adport, Dailiport, Prograf, Qvaya, Tacni Transplant, Tacrolimus Accord, Tarnaltem, Crilomus, Sumilor, Tacni, Tacpan …
- Key facts
- Active substance
- Tacrolimus
- Drug class
- Calcineurin inhibitor
- ATC code
- L04AD02
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Advagraf 0.5 mg prolonged-release hard capsules / Advagraf 1 mg prolonged-release hard capsules / Advagraf 3 mg prolonged-release hard capsules · Envarsus 0.75 mg prolonged-release tablets / Envarsus 1 mg prolonged-release tablets / Envarsus 4 mg prolonged-release tablets · Modigraf 0.2 mg granules for oral suspension / Modigraf 1 mg granules for oral suspension · Protopic 0.03% ointment · Protopic 0.1% ointment
- Marketing authorisation holder
- Astellas Pharma Europe BV, Chiesi Farmaceutici S.p.A., Astellas Pharma Europe B.V., LEO Pharma A/S
- Information as of
- 2026-10-27
Key facts
Tacrolimus is a calcineurin inhibitor (immunosuppressant). Orally (Advagraf, Envarsus, Modigraf) it prevents and treats transplant rejection; as ointment (Protopic) it treats atopic dermatitis.
What it is used for
- Advagraf, Envarsus: prophylaxis of transplant rejection in adult kidney or liver recipients; treatment of rejection resistant to other immunosuppressants
- Modigraf (granules): prophylaxis in adult and paediatric kidney, liver or heart recipients; resistant rejection
- Protopic 0.1%: moderate to severe atopic dermatitis from 16 years; Protopic 0.03% also for children from 2 years (flare and maintenance treatment)
Dosing
- Oral formulations must not be switched without specialist supervision; dosing guided by clinical response and trough levels
- Advagraf (once daily in the morning): kidney 0.20 - 0.30 mg/kg/day; liver 0.10 - 0.20 mg/kg/day
- Envarsus (once daily in the morning): kidney 0.17 mg/kg/day; liver 0.11–0.13 mg/kg/day
- Modigraf (twice daily): adult kidney 0.20 - 0.30 mg/kg/day in 2 divided doses; further regimens in the full text
- Protopic: flare treatment twice daily until clearance; children from 2 years use 0.03% only; maintenance once a day twice weekly
Contraindications
- Hypersensitivity to tacrolimus or any excipient
- Hypersensitivity to other macrolides
Important warnings
- Medication errors from unsupervised switching between formulations can cause graft rejection or overexposure
- Systemic: increased risk of infections (incl. CMV, BK virus nephropathy, PML) and malignancies; monitor blood pressure, ECG, glucose, potassium, renal and liver function
- Systemic: PRES, nephrotoxicity, QT prolongation; avoid live attenuated vaccines
- Protopic: minimise sun and UV exposure; not for skin barrier defects or immunodeficiency
Side effects
- Systemic, very common: tremor, renal impairment, hyperglycaemia, diabetes mellitus, hyperkalaemia, infections, hypertension, insomnia
- Protopic: about 50% have application-site irritation; very common burning and pruritus, common erythema and alcohol intolerance
- Protopic: increased risk of folliculitis, acne and herpes viral infections
Interactions
- Systemic: metabolised by CYP3A4; avoid strong CYP3A4 inhibitors (e.g. ritonavir, ketoconazole, clarithromycin) or monitor levels closely
- Avoid grapefruit; ciclosporin: additive nephrotoxicity; avoid potassium-sparing diuretics
- Protopic: low systemic exposure; caution with systemic CYP3A4 inhibitors in widespread disease
Pregnancy and breastfeeding
- Systemic: crosses the placenta; use only if no safer alternative; neonatal hyperkalaemia possible; do not breast-feed
- Protopic: not in pregnancy unless clearly necessary; breast-feeding not recommended
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- AdvagrafAstellas Pharma Europe BV · EMEA/H/C/000712
- EnvarsusChiesi Farmaceutici S.p.A. · EMEA/H/C/002655
- ModigrafAstellas Pharma Europe B.V. · EMEA/H/C/000954
- ProtopicLEO Pharma A/S · EMEA/H/C/000374
- Tacforius · genericTeva B.V. · EMEA/H/C/004435
Source: European Medicines Agency (EMA), product information
Austria
- AdportSandoz Gmbh · 1 register entry
- DailiportSandoz Gmbh · 1 register entry
- PrografAstellas Pharma Ges.M.B.H. · 2 register entries
- QvayaPelpharma Handels Gmbh · 1 register entry
- Tacni TransplantTeva B.V · 1 register entry
- Tacrolimus AccordAccord Healthcare B.V. · 1 register entry
- TarnaltemGlenmark Arzneimittel Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- CrilomusHexal Ag · 1 register entry
- DailiportHexal Ag · 1 register entry
- PrografAstellas Pharma Gmbh, Pb Pharma Gmbh · 3 register entries
- QvayaBay Pharma Gmbh · 1 register entry
- SumilorKlinge Pharma Gmbh · 1 register entry
- TacniTeva Gmbh · 1 register entry
- TacpanPanacea Biotec Germany Gmbh · 1 register entry
- Tacro-CellStadapharm Gmbh · 1 register entry
- Tacrolimus AlAliud Pharma Gmbh · 1 register entry
- Tacrolimus AscendAscend Gmbh · 1 register entry
- Tacrolimus DermapharmDermapharm Ag · 1 register entry
- Tacrolimus HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
Show all 15 brand names
- Tacrolimus HexalHexal Ag · 1 register entry
- Tacrolimus Retard HeumannHeumann Pharma Gmbh & Co. Generica Kg · 2 register entries
- TakrozemPierre Fabre Medicament · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- AdoportSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- AdvagrafASTELLAS PHARMA İLAÇ TİC. VE SAN. A.Ş. · 13 register entries
- DailiportSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 15 register entries
- PanolimusBİEM İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- PrografASTELLAS PHARMA İLAÇ TİC. VE SAN. A.Ş. · 4 register entries
- TacrotuONKO İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 28 more European countries
- Belgium
- Adoport, Dailiport, Prograft, Tacrolimus Medgen, Takrozem
- Bulgaria
- Програф
- Croatia
- Atezyrix, Dermitopic, Prograf
- Cyprus
- Prograf, Tacrolimus Accord
- Czechia
- Atezyrix, Dailiport, Gecrol, Prograf
- Denmark
- Adport, Dailiport, Prograf, Roltisa, Tacrolimus, Tarnaltem
- Estonia
- Dailiport, Lebsanan
- Finland
- Adport, Dailiport, Prograf, Tacrolimus Accord, Tacrolimus Eql Pharma, Tacrolimus Stada, Tarnaltem
- France
- Adoport, Conferoport, Prograf, Tacrolimus Atnahs Pharma, Tacrolimus Biogaran, Tacrolimus Eg, Tacrolimus Lp Eg, Tacrolimus Medgen, Takrozem
- Greece
- Atodrit-Dermo, Eczatope Derm, Prograf, Qvaya, Roltisa
- Hungary
- Prograf
- Iceland
- Advagraf, Dailiport, Envarsus, Modigraf, Protopic, Tacforius, Tacni
- Ireland
- Prograf, Tacrolimus Accord
- Italy
- Adoport, Carelimus, Conferoport, Prograf, Tacni, Tacrolimus Atnahs Pharma, Tacrolimus Eg
- Latvia
- Dailiport, Lebsanan
- Liechtenstein
- Advagraf, Envarsus, Modigraf, Protopic, Tacforius
- Lithuania
- Dailiport, Lebsanan
- Luxembourg
- Prograft, Sumilor, Takrozem
- Malta
- Prograf
- Netherlands
- Adport, Conferoport, Dailiport, Prograft, Tacni, Tacrolimus Accord, Tacrolimus Cf, Tacrolimus Sandoz, Takrozem
- Norway
- Adport, Advagraf, Dailiport, Envarsus, Modigraf, Prograf, Protopic, Tacforius, Tacrolimus Eql Pharma, Tacrolimus Stada, Tacrolimus Strides, Takrolimus Accord, Tarnaltem
- Poland
- Cidimus, Dailiport, Dermitopic, Prograf, Tacrolimus
- Portugal
- Adoport, Dermitopic, Prograf, Tacrolímus Accord, Tacrolímus Cantabria
- Romania
- Prograf, Tacrolimus Sandoz
- Slovakia
- Atezyrix, Dailiport, Dermitopic, Gecrol, Prograf
- Slovenia
- Adoport, Dailiport, Prograf
- Spain
- Adoport, Cellmune, Conferoport, Prograf, Roltisa, Tacgalen, Tacrolimus Cinfa, Tacrolimus Stada, Tacrolimus Stadafarma
- Sweden
- Adport, Dailiport, Prograf, Qvaya, Tacni, Tacrolimus Eql Pharma, Tacrolimus Stada, Takrolimus Accord, Tarnaltem
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- European Medicines Agency. Advagraf – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/advagraf-epar-product-information_en.pdf
- European Medicines Agency. Envarsus – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/envarsus-epar-product-information_en.pdf
- European Medicines Agency. Modigraf – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/modigraf-epar-product-information_en.pdf
- European Medicines Agency. Protopic – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/protopic-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L04AD.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.