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: AMLHipres-5mg-Tablet-EE-FullProduct

Hipres 5 mg tabletid

MPID: EE-100009540-1288

Full name: Hipres 5 mg tabletid

- Invented name part: Hipres

- Strength part: 5 mg

- Pharmaceutical dose form part: tabletid

Name usage: Estonian (Republic of Estonia)


Authorised dose form: Tablet

Legal status of supply: Medicinal product subject to medical prescription

Domain: Human use

Resource status: Current


Product classification:

  • 100000095065 amlodipine
  • C08CA01 amlodipine

Marketing Authorisation 1 of 1

Authorisation number: 439004

Region: Republic of Estonia

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

Identifier:

  • LOC-100009540
  • ORG-100000627

Status: Valid - Renewed/Varied (2014-02-28)

Package 1 of 2

PCID: EE-100009540-1288-1122961

Description:
Blisterpakend (lamineeritud OPA-Al-PVC foolium, alumiiniumfoolium). 30 tabletti pakendis.

Marketing status:

  • Republic of Estonia: Marketed

Pack size:

  • 30 Tablet

Package: 1 Box (Cardboard)

Containing:

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

Containing: 30 Tablet

Manufactured Item

Dose form: Tablet

Unit of presentation: Tablet

Ingredient

Role: Active

Substance: Amlodipine maleate

Presentation strength: 6.48 milligram(s) / 1 tablet


Reference strength:
Amlodipine 5 milligram(s) / 1 tablet

Package 2 of 2

PCID: EE-100009540-1288-1551383

Description:
Blisterpakend (lamineeritud OPA-Al-PVC foolium, alumiiniumfoolium). 60 tabletti pakendis.

Marketing status:

  • Republic of Estonia: Marketed

Pack size:

  • 60 Tablet

Package: 1 Box (Cardboard)

Containing:

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

Containing: 60 tablet

Manufactured Item

Dose form: Tablet

Unit of presentation: Tablet

Ingredient

Role: Active

Substance: Amlodipine maleate

Presentation strength: 6.48 milligram(s) / 1 tablet


Reference strength:
Amlodipine 5 milligram(s) / 1 tablet

Administrable Product (1 of 1)

Dose form: Tablet

Unit of presentation:

Route of administration:

  • Oral use

Ingredients:

Ingredient

Role: Active

Substance: Amlodipine maleate

Presentation strength: 6.48 milligram(s) / 1 tablet


Reference strength:
Amlodipine 5 milligram(s) / 1 tablet