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: Sobril-10mg-Tablet-SE-IS-MPD-BBDL

Sobril® 10 mg Tablett

MPID: SE-100001390-00008880
EURDID: 2234

Full name: Sobril® 10 mg Tablett

- Invented name part: Sobril®

- Strength part: 10 mg

- Pharmaceutical dose form part: Tablett

Name usage: Swedish (Kingdom of Sweden)

Authorised dose form: Tablet

Legal status of supply: Medicinal product subject to special medical prescription

Domain: Human use

Resource status: Current

Product classification:

  • 100000093533 N05BA04

Marketing Authorisation 1 of 1

Authorisation number: 8880

Region: Kingdom of Sweden

Marketing authorisation holder: Pfizer AB

Identifier:

  • LOC-100005188

Status: Valid (1973-12-14)

Package 1 of 3

PCID:

Description:
Blister, 100 tabletter

Marketing status:

  • Kingdom of Sweden: Marketed

Pack size:

  • 10 Tablet

Package: 1 Box (Cardboard)

Containing:

Package: 10 Blister (Plastic) (Aluminium)

Containing: 10 Tablet

Manufactured Item

Dose form: Tablet

Unit of presentation: Tablet

Ingredient

Role: Active

Substance: Oxazepam

Presentation strength: 10 milligram(s) / 1 unit(s)

Reference strength:
Oxazepam 10 milligram(s) / 1 unit(s)

Ingredient

Role: Excipient

Substance: Calcium hydrogen phosphate dihydrate

Ingredient

Role: Excipient

Substance: Cellulose, microcrystalline

Ingredient

Role: Excipient

Substance: Magnesium stearate

Ingredient

Role: Excipient

Substance: Povidone

Ingredient

Role: Excipient

Substance: Silica, colloidal anhydrous

Ingredient

Role: Excipient

Substance: Sodium laurilsulfate

Ingredient

Role: Excipient

Substance: Sodium starch glycolate

Ingredient

Role: Excipient

Substance: Wheat starch

Package 2 of 3

PCID:

Description:
Blister, 25 tabletter

Marketing status:

  • Kingdom of Sweden: Marketed

Pack size:

  • 5 Tablet

Package: 1 Box (Cardboard)

Containing:

Package: 5 Blister (Plastic) (Aluminium)

Containing: 5 Tablet

Manufactured Item

Dose form: Tablet

Unit of presentation: Tablet

Ingredient

Role: Active

Substance: Oxazepam

Presentation strength: 10 milligram(s) / 1 unit(s)

Reference strength:
Oxazepam 10 milligram(s) / 1 unit(s)

Ingredient

Role: Excipient

Substance: Calcium hydrogen phosphate dihydrate

Ingredient

Role: Excipient

Substance: Cellulose, microcrystalline

Ingredient

Role: Excipient

Substance: Magnesium stearate

Ingredient

Role: Excipient

Substance: Povidone

Ingredient

Role: Excipient

Substance: Silica, colloidal anhydrous

Ingredient

Role: Excipient

Substance: Sodium laurilsulfate

Ingredient

Role: Excipient

Substance: Sodium starch glycolate

Ingredient

Role: Excipient

Substance: Wheat starch

Package 3 of 3

PCID:

Description:
Blister, 49 x 1 tablett (endos)

Marketing status:

  • Kingdom of Sweden: Marketed

Pack size:

  • 1 Tablet

Package: 1 Box (Cardboard)

Containing:

Package: 49 Unit-dose blister (Plastic) (Aluminium)

Containing: 1 Tablet

Manufactured Item

Dose form: Tablet

Unit of presentation: Tablet

Ingredient

Role: Active

Substance: Oxazepam

Presentation strength: 10 milligram(s) / 1 unit(s)

Reference strength:
Oxazepam 10 milligram(s) / 1 unit(s)

Ingredient

Role: Excipient

Substance: Calcium hydrogen phosphate dihydrate

Ingredient

Role: Excipient

Substance: Cellulose, microcrystalline

Ingredient

Role: Excipient

Substance: Magnesium stearate

Ingredient

Role: Excipient

Substance: Povidone

Ingredient

Role: Excipient

Substance: Silica, colloidal anhydrous

Ingredient

Role: Excipient

Substance: Sodium laurilsulfate

Ingredient

Role: Excipient

Substance: Sodium starch glycolate

Ingredient

Role: Excipient

Substance: Wheat starch

Administrable Product (1 of 1)

Dose form: Tablet

Unit of presentation:

Route of administration:

  • Oral use

Ingredients:

Ingredient

Role: Active

Substance: Oxazepam

Presentation strength: 10 milligram(s) / 1 unit(s)

Reference strength:
Oxazepam 10 milligram(s) / 1 unit(s)

Ingredient

Role: Excipient

Substance: Calcium hydrogen phosphate dihydrate

Ingredient

Role: Excipient

Substance: Cellulose, microcrystalline

Ingredient

Role: Excipient

Substance: Magnesium stearate

Ingredient

Role: Excipient

Substance: Povidone

Ingredient

Role: Excipient

Substance: Silica, colloidal anhydrous

Ingredient

Role: Excipient

Substance: Sodium laurilsulfate

Ingredient

Role: Excipient

Substance: Sodium starch glycolate

Ingredient

Role: Excipient

Substance: Wheat starch