UFIS-SWE-IG
0.1.0 - ci-build

UFIS-SWE-IG, published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/joofio/ufis-swe-ig/ and changes regularly. See the Directory of published versions

Example Bundle: SandimmunNeoral100mgmlorallos-SE-PLC-MPD-BBDL

Sandimmun Neoral 100 mg/ml oral lösning

MPID: SE-100003469-00012311
EURDID: 745

Full name: Sandimmun Neoral 100 mg/ml oral lösning

- Invented name part: Sandimmun Neoral

- Strength part: 100 mg/ml

- Pharmaceutical dose form part: oral lösning

Name usage: Swedish (Kingdom of Sweden)

Authorised dose form: Oral solution

Legal status of supply: Medicinal product subject to medical prescription

Domain: Human use

Resource status: Current

Product classification:

  • 100000096879 ciclosporin

Marketing Authorisation 1 of 1

Authorisation number: 12311

Region: Kingdom of Sweden

Marketing authorisation holder: Novartis Sverige AB

Identifier:

  • LOC-100020269

Status: Valid (1994-09-09)

Package 1 of 1

PCID:

Description:
Flaska, 1 x 50 ml

Marketing status:

  • Kingdom of Sweden: Marketed

Pack size:

  • 1 Bottle

Package: 1 Box (Cardboard)

Containing:

Package: 1 Bottle (Glass type III)

Containing: 50 millilitre(s)

Manufactured Item

Dose form: Oral solution

Unit of presentation: Bottle

Ingredient

Role: Active

Substance: Ciclosporin

Concentration strength: 100 milligram(s) / 1 millilitre(s)

Reference strength:
Ciclosporin 100 milligram(s) / 1 millilitre(s)

Ingredient

Role: Excipient

Substance: All-rac-alpha-Tocopherol

Concentration strength: 5 milligram(s) / 1 millilitre(s)

Reference strength:
All-rac-alpha-Tocopherol 5 milligram(s) / 1 millilitre(s)

Ingredient

Role: Excipient

Substance: Macrogolglycerol hydroxystearate

Concentration strength: 5 milligram(s) / 1 millilitre(s)

Reference strength:
Macrogolglycerol hydroxystearate 5 milligram(s) / 1 millilitre(s)

Ingredient

Role: Excipient

Substance: Maize oil, refined

Concentration strength: 5 milligram(s) / 1 millilitre(s)

Reference strength:
Maize oil, refined 5 milligram(s) / 1 millilitre(s)

Ingredient

Role: Excipient

Substance: Propylene glycol

Concentration strength: 5 milligram(s) / 1 millilitre(s)

Reference strength:
Propylene glycol 5 milligram(s) / 1 millilitre(s)

Administrable Product (1 of 1)

Dose form: Oral solution

Unit of presentation:

Route of administration:

  • Oral use

Ingredients:

Ingredient

Role: Active

Substance: Ciclosporin

Concentration strength: 100 milligram(s) / 1 millilitre(s)

Reference strength:
Ciclosporin 100 milligram(s) / 1 millilitre(s)

Ingredient

Role: Excipient

Substance: All-rac-alpha-Tocopherol

Concentration strength: 5 milligram(s) / 1 millilitre(s)

Reference strength:
All-rac-alpha-Tocopherol 5 milligram(s) / 1 millilitre(s)

Ingredient

Role: Excipient

Substance: Macrogolglycerol hydroxystearate

Concentration strength: 5 milligram(s) / 1 millilitre(s)

Reference strength:
Macrogolglycerol hydroxystearate 5 milligram(s) / 1 millilitre(s)

Ingredient

Role: Excipient

Substance: Maize oil, refined

Concentration strength: 5 milligram(s) / 1 millilitre(s)

Reference strength:
Maize oil, refined 5 milligram(s) / 1 millilitre(s)

Ingredient

Role: Excipient

Substance: Propylene glycol

Concentration strength: 5 milligram(s) / 1 millilitre(s)

Reference strength:
Propylene glycol 5 milligram(s) / 1 millilitre(s)