System service message June 15-18
Due to technical maintenance links to many smPCs will not work between 19:00 on Friday 15 June to 7:00 on Monday 18 June 2018. This applies to medicinal products approved in central procedure, which involves that sMPCs for such products are published on the EMA website.
Which search expressions may be used?
- You may search a product name, name of an active pharmaceutical ingredient (API), ATC code, product number, MA Holder, reimbursement code or illness/indication included in the general reimbursement scheme.
See list of reimbursement codes.
- You may use automatic truncation by searching a part of product name or API, but the truncation symbol* cannot be used.
The default search returns medicines that are sold in Norway: Medicines that are marketed, discontinued or withdrawn less than 3 months ago. Click "Endre dine søkeinnstillinger" (change your search settings) if you want to find more or other medicines.
Which medicines are displayed in the medicine database?
The database displays medicines with one on the following statuses:
- Approved, but not marketed (in Norway)
- Approved without Norwegian product information, not marketed
- Parallel imported
- Withdrawn (after 2008)
- The search filter "Originallegemidler/generika" (Original/generic medicines) include all medicines that are not parallel imported, i.e. original, generic, biosimilar and bibliopraphic medicines.
- Only "master packages" are displayed for parallel imported medicines.
- A few medicines without marked authorisation are displayed in cases this has been decided specifically.
What kind of information about medicines are displayed in medicine search?
Link to SPC are shown for medicines that are
- Marketed in Norway
- Withdrawn less than 3 months ago (may still be sold in Norwegian pharmacies)
- Approved, but not marketed
Links to SPCs work in the following manner:
- As for medicines approved through central procedure: The medicine database links to SPCs on EMA's website.
- As for medicines approved nationally or through MRP or DCP: The medicine database links to SPCs on NoMA's file server.
Other information displayed:
- Links to PILs in
Felleskatalogen (a private-own website) for marketed packages (with some exemptions, like parallel imported packages).
- Information on regulatory affairs: Marketing status, MA Holder, date of issued MA and marketing date. As for parallel imported medicines export country is displayed.
- ATC codes and product numbers.
- Information on price, generic substitution, reimbursement status and conditions for reimbursement.
- Information about interactions according to certain criteria of inclusion.
- APIs with general reimbursement.
- Information on whether a medicine faces additional monitoring («black triangle»)
What kind of information is not displayed in the medicine database?
- Food supplements
- Medicines produced by hospital pharmacies, not having general reimbursement
- Medicines with other statuses than those mentioned above, e.g. “suspended”.
- Interactions regarding veterinary medicines. What kind of information is until further not displayed in medicine search?
NoMA aims at displaying the following information:
- Veterinary SPCs for nationally approved medicines with both human and veterinarian indication.
- Additional information regarding dosage form, e.g. taste.
- Better presentation of approved medicines that are about to be marketed, i.e. medicines with the following statuses: Kontrollert VRS, Godkjent VRS and Kan prisbehandles.
Who adds SPCs and PILs?
SPCs displayed in the NoMA medicine database are published by NoMA itself (by EMA as for centrally approved medicines). The database displays links to PILs in Felleskatalogen, which is a private-own webiste. Each MA Holder must send Felleskatalogen an updated
- Avregistrert: Withdrawn
- Blå resept: General reimbursement
- Godkjent, ikke markedsført: Approved, not marketed
- Godkjent uten norsk PI, ikke markedsført: Approved without Norwegian product information, not marketed
- Handelsnavn: Product name
- Markedsført: Marketed
- Midlertidig utgått: Discontinued
- MT-innehaver: Market authorisation Holder (MAH)
- Pakningsvedlegg: Patient Information Leaflet
- Refusjonskode: Reimbursement code
- Utgått: Withdrawn