Consultations on inclusion in the substitution list
Published:
Changes
The inclusion of medicines in the substitution list must, in certain cases, be sent for consultation. Such consultations are distributed to relevant stakeholders, typically with a consultation period of three weeks.
Page contents
Criteria for when inclusion in the substitution list is sent for consultation:
- The medicines have not been assessed with a bioequivalence study (with some exceptions).
- The medicines have been granted marketing authorization based on a bibliographic application (Medicinal Products Regulation § 3-12 – Article 10a – well-established use).
- The medicines have been granted marketing authorization based on a biosimilar application (Article 10(4)).
- The medicines are for local use (eye, ear, skin, and mucous membranes) where bioequivalence is not relevant.
- NOMA seeks input on the evaluation of medical equivalence and considerations regarding medicine substitution in pharmacies.
Consultations
2025
There are currently no consultations for 2025 yet.
2024
|
Medicine |
Pharmaceutical Form |
Consultation Documents |
|
Natalizumab |
Concentrate for solution for infusion |
Consultation Letter Assessment of Substitutability |
|
Methadone |
Mixture, solution |
Consultation Letter Assessment of Substitutability |
|
Ustekinumab |
Solution for injection in pre-filled syringe |
Consultation Letter Assessment of Substitutability |
|
Ciclesonide |
Inhalation aerosol, solution |
Consultation Letter Assessment of Substitutability |
|
Brinzolamide and Timolol |
Eye drops, suspension |
Consultation Letter Assessment of Substitutability |
|
Brinzolamide and Brimonidine |
Eye drops, suspension |
Consultation Letter Assessment of Substitutability |
|
Orlistat |
Capsules |
Consultation Letter Assessment of Substitutability |
|
Tocilizumab |
Solution for injection |
Consultation Letter Assessment of Substitutability |
|
Dexamfetamine |
Tablets |
Consultation Letter Assessment of Substitutability |
|
Adapalene and Benzoyl Peroxide |
Gel |
Consultation Letter Assessment of Substitutability |
|
Azelastine and Fluticasone |
Nasal spray, suspension |
Consultation Letter Assessment of Substitutability |
|
Atropine |
Solution for injection |
Consultation Letter Assessment of Substitutability |
|
Rosuvastatin and Ezetimibe |
Film-coated tablets |
Consultation Letter, Assessment of Substitutability |
|
Beclometasone Dipropionate and Formoterol Fumarate Dihydrate |
Inhalation aerosol, solution |
Consultation Letter Assessment of Substitutability |
|
Tobramycin and Dexamethasone |
Eye drops, suspension |
Consultation Letter Assessment of Substitutability |
2023
|
Medicine |
Pharmaceutical Form |
Consultation Documents |
|
Insulin Aspart |
Solution for injection in pre-filled pen |
Consultation Letter Assessment of Substitutability |
|
Filgrastim |
Solution for injection/infusion in pre-filled syringe |
Consultation Letter Assessment of Substitutability |
|
Trastuzumab |
Powder for concentrate for solution for infusion |
Consultation Letter Assessment of Substitutability |
|
Ranibizumab |
Solution for injection |
Consultation Letter Assessment of Substitutability |
|
Apixaban |
Film-coated tablets |
Consultation Letter Assessment of Substitutability |
|
Ephedrine |
Solution for injection |
Consultation Letter Assessment of Substitutability |
|
Adalimumab |
Solution for injection in pre-filled pen and syringe |
Consultation Letter Assessment of Substitutability |
2022
|
Medicine |
Pharmaceutical Form |
Consultation Documents |
|
Teriparatide |
Solution for injection |
Consultation Letter Assessment of Substitutability (Livogiva, Movymia) Consultation Feedback |
|
Sodium Chloride |
Tablets |
Consultation Letter Assessment of Substitutability |
|
Dexamethasone and Chloramphenicol |
Eye drops |
Consultation Letter, Assessment of Substitutability |
|
Olopatadine |
Eye drops |
Consultation Letter Assessment of Substitutability |
|
Calcipotriol and Betamethasone |
Gel |
Consultation Letter Assessment of Substitutability |
|
Etanercept |
Solution for injection |
Consultation Letter Assessment of Substitutability |
|
Tobramycin |
Inhalation solution for nebulizer |
Consultation Letter Assessment of Substitutability |
|
Insulin Glargine |
Solution for injection in pre-filled pen |
Consultation Letter Assessment of Substitutability |
|
Enoxaparin |
Solution for injection |
Consultation Letters (Inhixa, Ghemaxan) Assessment of Substitutability (Inhixa and Klexane, Ghemaxan and Klexane) |
|
Pegfilgrastim |
Solution for injection |
Consultation Letter Assessment of Substitutability |
|
Teriparatide |
Solution for injection |
Consultation Letter Assessment of Substitutability |
|
Budesonide |
Depot capsule and capsule with modified release |
Consultation Letter Assessment of Substitutability |