Bundle bundle-drug-product-composition-pq-ex1 of type collection

Entry 1 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition

Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"

description: Stelbatalol is formulated as an immediate-release, oral, solid dosage form in strengths of 20 mg of the free base equivalent. The 20 mg strength is presented as an orange, round, film coated tablet, debossed with '175' on one side.

Names

-	ProductName	Type
*	Stalbatolol	Proprietary (CodeSystem - Product Name Type#Proprietary)

Entry 2 - fullUrl = urn:uuid:88a068e2-1d97-337b-3b9c-4b3f14bc3923

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition

Resource PackagedProductDefinition "88a068e2-1d97-337b-3b9c-4b3f14bc3923"

Profile: PackagedProductDefinition - Drug PQ

packageFor: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)

description: The commercial primary pack is a high-density polyethylene (HDPE) bottle with a child-resistant polypropylene (PP) screw cap. Inside the bottle is a desiccant, containing silica gel. Induction seal membranes provide additional tamper evidence. For further details of the packaging components, see ‘P.7 Container Closure System for Drug Product’.

Entry 3 - fullUrl = urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a65

Resource Ingredient:

Generated Narrative: Ingredient

Resource Ingredient "b89ed9d2-80f9-0cfb-70a1-5a6572e73a65"

status: ACTIVE

for: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)

role: Active (Ingredient Role#100000072072)

substance

Codes

-	Reference
*	See above (SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380474: Stelbatolol)

strength

presentation: 15.2 mg/1 tablet

strength

concentration: 97.9 % w/w

Entry 4 - fullUrl = urn:uuid:b89ed9d3-80f9-0cfb-70a1-5a6572e73a65

Resource Ingredient:

Generated Narrative: Ingredient

Resource Ingredient "b89ed9d3-80f9-0cfb-70a1-5a6572e73a65"

status: ACTIVE

for: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)

role: Excipient (Ingredient Role#100000072082)

function: Diluent (CodeSystem - Ingredient Function#diluent)

substance

Codes

-	Reference
*	See above (SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380475: Mannitol)

strength

presentation: 145.0 mg/1 tablet

strength

concentration: 1 % w/w

Entry 5 - fullUrl = urn:uuid:b89ed9d2-80f9-0cfb-71a1-5a6572e73a65

Resource Ingredient:

Generated Narrative: Ingredient

Resource Ingredient "b89ed9d2-80f9-0cfb-71a1-5a6572e73a65"

status: ACTIVE

for: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)

role: Excipient (Ingredient Role#100000072082)

function: Disintegrant (CodeSystem - Ingredient Function#disintegrant)

substance

Codes

-	Reference
*	See above (SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380476: Maize starch)

strength

presentation: 13.8 mg/1 tablet

strength

concentration: 0.5 % w/w

Entry 6 - fullUrl = urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a66

Resource Ingredient:

Generated Narrative: Ingredient

Resource Ingredient "b89ed9d2-80f9-0cfb-70a1-5a6572e73a66"

status: ACTIVE

for: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)

role: Excipient (Ingredient Role#100000072082)

function: Disintegrant (CodeSystem - Ingredient Function#disintegrant)

substance

Codes

-	Reference
*	See above (SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380477: Calcium carboxymethylcellulose)

strength

presentation: 4.0 mg/1 tablet

strength

concentration: 0.25 % w/w

Entry 7 - fullUrl = urn:uuid:b89ed9d3-80f9-0cfb-70a1-5a6572e73a66

Resource Ingredient:

Generated Narrative: Ingredient

Resource Ingredient "b89ed9d3-80f9-0cfb-70a1-5a6572e73a66"

status: ACTIVE

for: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)

role: Excipient (Ingredient Role#100000072082)

function: Lubricant (CodeSystem - Ingredient Function#lubricant)

substance

Codes

-	Reference
*	See above (SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380478: Magnesium stearate)

strength

presentation: 2.0 mg/1 tablet

strength

concentration: 0.35 % w/w

Entry 8 - fullUrl = urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380474

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380474"

grade: In-house (CodeSystem - Grade#in-house)

Names

-	Name
*	Stelbatolol

Entry 9 - fullUrl = urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380475

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380475"

grade: NF / Ph Eur (CodeSystem - Grade#NF-PH-Eur)

Names

-	Name
*	Mannitol

Entry 10 - fullUrl = urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380476

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380476"

grade: NF / Ph Eur (CodeSystem - Grade#NF-PH-Eur)

Names

-	Name
*	Maize starch

Entry 11 - fullUrl = urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380477

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380477"

grade: NF / Ph Eur (CodeSystem - Grade#NF-PH-Eur)

Names

-	Name
*	Calcium carboxymethylcellulose

Entry 12 - fullUrl = urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380478

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380478"

grade: NF / Ph Eur (CodeSystem - Grade#NF-PH-Eur)

Names

-	Name
*	Magnesium stearate