UnicomIG
0.1.0 - ci-build

UnicomIG, 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/hl7-eu/unicom-ig/ and changes regularly. See the Directory of published versions

Example Bundle: 011-Betaklav500-125-EE-FullProduct

Betaklav 500 mg/125 mg õhukese polümeerikattega tabletid

MPID: EE-100009540-30722
PMSID: 0000000000006

Full name: Betaklav 500 mg/125 mg õhukese polümeerikattega tabletid

- Invented name part: Betaklav

- Strength part: 500mg/125mg

- Pharmaceutical dose form part: õhukese polümeerikattega tabletid

Name usage: Estonian (Republic of Estonia)

Authorised dose form: Film-coated tablet

Legal status of supply: Medicinal Product subject to medical prescription

Domain: Human use

Resource status: Current

Product classification:

  • 100000096162 amoxicillin and beta-lactamase inhibitor
  • J01CR02 amoxicillin and beta-lactamase inhibitor

Marketing Authorisation 1 of 1

Authorisation number: 879415

Region: Republic of Estonia

Marketing authorisation holder: KRKA, d.d., Novo mesto

Identifier:

  • LOC-100009540
  • ORG-100000627

Status: Valid - Renewed/Varied (2021-02-03)

Package 1 of 3

PCID: EE-100009540-30722-1635117

Description:
Ribapakend (Al/Al) 10 õhukese polümeerikattega tabletti karbis

Marketing status:

  • Republic of Estonia: Marketed

Pack size:

  • 10 tablet

Package: 1 Box (Cardboard)

Containing:

Package: 1 Strip (Aluminium)

Containing: 10

Manufactured Item

Dose form: Film-coated tablet

Unit of presentation: Tablet

Ingredient

Role: Active

Substance: AMOXICILLIN TRIHYDRATE

Presentation strength: 573.892 milligram(s) / 1 tablet

Reference strength:
Amoxicillin 500 milligram(s) / 1 tablet

Ingredient

Role: Active

Substance: POTASSIUM CLAVULANATE

Presentation strength: 151.915 milligram(s) / 1 tablet

Reference strength:
CLAVULANIC ACID 125 milligram(s) / 1 tablet

Package 2 of 3

PCID: EE-100009540-30722-1635207

Description:
Ribapakend (Al/Al) 500 õhukese polümeerikattega tabletti karbis

Marketing status:

  • Republic of Estonia: Marketed

Pack size:

  • 500 tablet

Package: 1 Box (Cardboard)

Containing:

Package: 1 Strip (Aluminium)

Containing: 500

Manufactured Item

Dose form: Film-coated tablet

Unit of presentation: Tablet

Ingredient

Role: Active

Substance: AMOXICILLIN TRIHYDRATE

Presentation strength: 573.892 milligram(s) / 1 tablet

Reference strength:
Amoxicillin 500 milligram(s) / 1 tablet

Ingredient

Role: Active

Substance: POTASSIUM CLAVULANATE

Presentation strength: 151.915 milligram(s) / 1 tablet

Reference strength:
CLAVULANIC ACID 125 milligram(s) / 1 tablet

Package 3 of 3

PCID: EE-100009540-30722-1635139

Description:
Blisterpakend (OPA/Al/PVC foil/Al foil) 14 õhukese polümeerikattega tabletti karbis

Marketing status:

  • Republic of Estonia: Marketed

Pack size:

  • 14 tablet

Package: 1 Box (Cardboard)

Containing:

Package: 1 Blister (Orientated PolyAmide) (Aluminium) (PolyVinyl Chloride)

Containing: 14

Manufactured Item

Dose form: Film-coated tablet

Unit of presentation: Tablet

Ingredient

Role: Active

Substance: AMOXICILLIN TRIHYDRATE

Presentation strength: 573.892 milligram(s) / 1 tablet

Reference strength:
Amoxicillin 500 milligram(s) / 1 tablet

Ingredient

Role: Active

Substance: POTASSIUM CLAVULANATE

Presentation strength: 151.915 milligram(s) / 1 tablet

Reference strength:
CLAVULANIC ACID 125 milligram(s) / 1 tablet

Administrable Product (1 of 1)

Dose form: Film-coated tablet

Unit of presentation: Tablet

Route of administration:

  • Oral use

Ingredients:

Ingredient

Role: Active

Substance: AMOXICILLIN TRIHYDRATE

Presentation strength: 573.892 milligram(s) / 1 tablet

Reference strength:
Amoxicillin 500 milligram(s) / 1 tablet

Ingredient

Role: Active

Substance: POTASSIUM CLAVULANATE

Presentation strength: 151.915 milligram(s) / 1 tablet

Reference strength:
CLAVULANIC ACID 125 milligram(s) / 1 tablet