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: 015-CopaliaHCT-EE-FullProduct

COPALIA HCT 160mg / 12.5mg / 10mg õhukese polümeerikattega tabletid

MPID: EE-100010531-3309

Full name: COPALIA HCT 160mg / 12.5mg / 10mg õhukese polümeerikattega tabletid

- Invented name part: COPALIA HCT

- Strength part: 160mg / 12.5mg / 10mg

- 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: Provisional

Product classification:

  • C09DX01 valsartan, amlodipine and hydrochlorothiazide
  • 100000116213 valsartan, amlodipine and hydrochlorothiazide

Marketing Authorisation 1 of 1

Authorisation number: EU/1/09/575

Region: Republic of Estonia

Marketing authorisation holder: Novartis Europharm Limited

Identifier:

  • LOC-100010531
  • ORG-100007373

Status: Valid (2009-11-04)

Package 1 of 2

PCID: EE-100010531-3310-1448951

Description:
Package of 14

Marketing status:

  • Republic of Estonia: Not marketed

Pack size:

  • 28 Tablet

Package: 1 Box

Containing:

Package: 1 Blister (PolyVinylidene Chloride) (PolyVinyl Chloride)

Containing: 14

Manufactured Item

Dose form: Film-coated tablet

Unit of presentation: Tablet

Ingredient

Role: active

Substance: Amlodipine besilate

Presentation strength: 13.87 mg / 1 Tablet

Reference strength:
Amlodipine 10 mg / 1 Tablet

Ingredient

Role: active

Substance: Valsartan

Presentation strength: 160 mg / 1 Tablet

Reference strength:
Valsartan 160 mg / 1 Tablet

Ingredient

Role: active

Substance: Hydrochlorothiazide

Presentation strength: 12.5 mg / 1 Tablet

Reference strength:
Hydrochlorothiazide 12.5 mg / 1 Tablet

Package 2 of 2

PCID: EE-100010531-3310-1448962

Description:
Package of 28

Marketing status:

  • Republic of Estonia: Not marketed

Pack size:

  • 28 Tablet

Package: 1 Box

Containing:

Package: 2 Blister (PolyVinylidene Chloride) (PolyVinyl Chloride)

Containing: 14

Manufactured Item

Dose form: Film-coated tablet

Unit of presentation: Tablet

Ingredient

Role: active

Substance: Amlodipine besilate

Presentation strength: 13.87 mg / 1 Tablet

Reference strength:
Amlodipine 10 mg / 1 Tablet

Ingredient

Role: active

Substance: Valsartan

Presentation strength: 160 mg / 1 Tablet

Reference strength:
Valsartan 160 mg / 1 Tablet

Ingredient

Role: active

Substance: Hydrochlorothiazide

Presentation strength: 12.5 mg / 1 Tablet

Reference strength:
Hydrochlorothiazide 12.5 mg / 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: Amlodipine besilate

Presentation strength: 13.87 mg / 1 Tablet

Reference strength:
Amlodipine 10 mg / 1 Tablet

Ingredient

Role: active

Substance: Valsartan

Presentation strength: 160 mg / 1 Tablet

Reference strength:
Valsartan 160 mg / 1 Tablet

Ingredient

Role: active

Substance: Hydrochlorothiazide

Presentation strength: 12.5 mg / 1 Tablet

Reference strength:
Hydrochlorothiazide 12.5 mg / 1 Tablet