---

Generated Narrative: Composition

status: FINAL

type: Package Leaflet (#100000155538)

date: 2002-08-01 01:28:17+0000

author: Organization/85c5d81e-9d5a-4a15-8b9d-42bbbe0409c8 "PHARMACIA & UPJOHN COMPANY LLC"

title: TEST PURPOSES ONLY - Aromasin (exemestane) Tablets 25 mg tablets

confidentiality: U

---

AROMASIN is used in women who are past menopause for the treatment of:are still having menstrual periods (are not past menopause). AROMASIN is only for women who are past menopause. have weak or brittle bones (osteoporosis)Take AROMASIN exactly as your doctor tells you. Take AROMASIN 1 time each day after a meal. If you take too much AROMASIN, call your doctor right away or go to nearest hospital emergency room.Your doctor will do blood tests to check your vitamin D level before starting treatment with AROMASIN. AROMASIN may cause decreased fertility in males and females. Talk to your doctor if you have concerns about fertility. These are not all the possible side effects of AROMASIN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Store AROMASIN at room temperature 68°F to 77°F (20°C to 25°C). Keep AROMASIN and all medicines out of the reach of children.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AROMASIN for a condition for which it was not prescribed. Do not give AROMASIN to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or doctor for information about AROMASIN that is written for health professionals.Active ingredient: exemestane Inactive ingredients: mannitol, crospovidone, polysorbate 80, hypromellose, colloidal silicon dioxide, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, simethicone, polyethylene glycol 6000, sucrose, magnesium carbonate, titanium dioxide, methylparaben, and polyvinyl alcohol. Logo LAB-0399-9.0 For more information, go to www.AROMASIN.com or call 1-888-AROMASIN (1-888-276-6274).

---

Additional Document Content

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2. 85c5d81e-9d5a-4a15-8b9d-42bbbe0409c8/{3}

Generated Narrative: Organization

Resource Organization "85c5d81e-9d5a-4a15-8b9d-42bbbe0409c8"

Profile: Organization (ePI)

identifier: id: 618054084 (OFFICIAL)

active: true

type: Manufacturer (#tbd "Marketing authorisation holder")

name: PHARMACIA & UPJOHN COMPANY LLC

telecom: ph: 1-908-901-8000(WORK)

address: 100 Route 206 North Peapack, NJ 07977 United States(WORK)

---

3. 56b3b73e-dba0-4447-b8cd-1e24ed637017/{3}

Generated Narrative: RegulatedAuthorization

Resource RegulatedAuthorization "56b3b73e-dba0-4447-b8cd-1e24ed637017"

Profile: RegulatedAuthorization (ePI)

identifier: id: 21400AMY00186 (OFFICIAL)

subject: MedicinalProductDefinition/f1b25777-da7a-4a35-98af-ab18d3246d54

type: Marketing Authorisation (#/#100000072062)

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status: Active (PublicationStatus#active)

statusDate: 2002-08-01 01:28:17+0000

holder: Organization/85c5d81e-9d5a-4a15-8b9d-42bbbe0409c8 "PHARMACIA & UPJOHN COMPANY LLC"

---

4. f1b25777-da7a-4a35-98af-ab18d3246d54/{3}

Generated Narrative: MedicinalProductDefinition

Resource MedicinalProductDefinition "f1b25777-da7a-4a35-98af-ab18d3246d54"

Profile: MedicinalProductDefinition (ePI)

identifier: id: 123456

type: Medicinal Product (MedicinalProductType#MedicinalProduct)

domain: Human use (MedicinalProductDomain#Human)

status: Active (PublicationStatus#active)

legalStatusOfSupply: Medicinal product subject to medical prescription (Referentials Management Services CodeSystem#100000072084)

name

productName: Aromasin (exemestane) Tablets 25 mg

type: Full name (Referentials Management Services CodeSystem#220000000001)

NameParts

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*	Tablet	Pharmaceutical dose form part (Referentials Management Services CodeSystem#220000000005)

CountryLanguages

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*	United States of America (unknown#us)	United States of America (unknown#us)	English (unknown#en)

---

5. 39151aef-f61a-40cb-86fc-d0e556fa07ef/{3}

Generated Narrative: PackagedProductDefinition

Resource PackagedProductDefinition "39151aef-f61a-40cb-86fc-d0e556fa07ef"

Profile: PackagedProductDefinition (ePI)

identifier: id: NDC:0009-7663-04 (OFFICIAL)

name: Aromasin (exemestane) Tablets 25 mg - 28 tablets [14 tablets (PTP) x 2]

type: Chemical Medininal Prodcut (Referentials Management Services CodeSystem#100000155527)

packageFor: MedicinalProductDefinition/f1b25777-da7a-4a35-98af-ab18d3246d54

status: Active (PublicationStatus#active)

statusDate: 2002-08-01 01:28:17+0000

containedItemQuantity: 30 tablet

manufacturer: Organization/85c5d81e-9d5a-4a15-8b9d-42bbbe0409c8 "PHARMACIA & UPJOHN COMPANY LLC"

---

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Generated Narrative: AdministrableProductDefinition

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Profile: AdministrableProductDefinition (ePI)

identifier: id: 0x712653c26276d3c31c11a7c198246a38

status: ACTIVE

formOf: MedicinalProductDefinition/f1b25777-da7a-4a35-98af-ab18d3246d54

administrableDoseForm: Tablet (Referentials Management Services CodeSystem#10219000)

unitOfPresentation: Tablet (Referentials Management Services CodeSystem#15054000)

producedFrom: ManufacturedItemDefinition/23fed712-2d60-461d-83a6-5fb939b2a939

routeOfAdministration

code: Oral use (Referentials Management Services CodeSystem#20053000)

TargetSpecies

-	Code
*	Human (Referentials Management Services CodeSystem#100000109093)

---

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Generated Narrative: ManufacturedItemDefinition

Resource ManufacturedItemDefinition "23fed712-2d60-461d-83a6-5fb939b2a939"

Profile: ManufacturedItemDefinition (ePI)

identifier: id: 874291 (OFFICIAL)

status: ACTIVE

manufacturedDoseForm: Tablet (#10219000)

unitOfPresentation: Tablet (#15054000)

manufacturer: Organization/85c5d81e-9d5a-4a15-8b9d-42bbbe0409c8 "PHARMACIA & UPJOHN COMPANY LLC"

---

8. 5a574ff2-f3e6-4aaa-8d3c-27e6ab343533/{3}

Generated Narrative: Ingredient

Resource Ingredient "5a574ff2-f3e6-4aaa-8d3c-27e6ab343533"

Profile: Ingredient (ePI)

identifier: id: NY22HMQ4BX (OFFICIAL)

status: ACTIVE

for: ManufacturedItemDefinition/23fed712-2d60-461d-83a6-5fb939b2a939

role: active (#00000072072)

Manufacturers

-	Manufacturer
*	Organization/85c5d81e-9d5a-4a15-8b9d-42bbbe0409c8 "PHARMACIA & UPJOHN COMPANY LLC"

substance

Strengths

-	Presentation[x]	Basis
*	25 mg	active ingredient - basis of strength (v3-RoleClassIngredientEntity#ACTIB)

---

9. f35c1543-e4e2-4215-b91c-f092b1fb9655/{3}

Generated Narrative: Ingredient

Resource Ingredient "f35c1543-e4e2-4215-b91c-f092b1fb9655"

Profile: Ingredient (ePI)

identifier: id: 68401960MK (OFFICIAL)

status: ACTIVE

for: ManufacturedItemDefinition/23fed712-2d60-461d-83a6-5fb939b2a939

role: Excipient (#100000072082)

Manufacturers

-	Manufacturer
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substance

---

10. 32e98fc8-b8fb-4bd9-a4d3-2ce97c151d61/{3}

Generated Narrative: Ingredient

Resource Ingredient "32e98fc8-b8fb-4bd9-a4d3-2ce97c151d61"

Profile: Ingredient (ePI)

identifier: id: OP1R32D61U (OFFICIAL)

status: ACTIVE

for: ManufacturedItemDefinition/23fed712-2d60-461d-83a6-5fb939b2a939

role: Excipient (#100000072082)

Manufacturers

-	Manufacturer
*	Organization/85c5d81e-9d5a-4a15-8b9d-42bbbe0409c8 "PHARMACIA & UPJOHN COMPANY LLC"

substance

---

11. 7b23dea1-ce14-4c13-8004-f297bb75eda0/{3}

Generated Narrative: Ingredient

Resource Ingredient "7b23dea1-ce14-4c13-8004-f297bb75eda0"

Profile: Ingredient (ePI)

identifier: id: 3OWL53L36A (OFFICIAL)

status: ACTIVE

for: ManufacturedItemDefinition/23fed712-2d60-461d-83a6-5fb939b2a939

role: Excipient (#100000072082)

Manufacturers

-	Manufacturer
*	Organization/85c5d81e-9d5a-4a15-8b9d-42bbbe0409c8 "PHARMACIA & UPJOHN COMPANY LLC"

substance

---

12. cc5753cd-e648-47d2-a135-503cd8a3e1da/{3}

Generated Narrative: Ingredient

Resource Ingredient "cc5753cd-e648-47d2-a135-503cd8a3e1da"

Profile: Ingredient (ePI)

identifier: id: 3NXW29V3WO (OFFICIAL)

status: ACTIVE

for: ManufacturedItemDefinition/23fed712-2d60-461d-83a6-5fb939b2a939

role: Excipient (#100000072082)

Manufacturers

-	Manufacturer
*	Organization/85c5d81e-9d5a-4a15-8b9d-42bbbe0409c8 "PHARMACIA & UPJOHN COMPANY LLC"

substance

---

13. db5e392b-e7b2-47dc-829c-ee5182986dca/{3}

Generated Narrative: Ingredient

Resource Ingredient "db5e392b-e7b2-47dc-829c-ee5182986dca"

Profile: Ingredient (ePI)

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status: ACTIVE

for: ManufacturedItemDefinition/23fed712-2d60-461d-83a6-5fb939b2a939

role: Excipient (#100000072082)

Manufacturers

-	Manufacturer
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substance

---

14. 5acc6759-a7f7-4380-ab2e-ad72e8587598/{3}

Generated Narrative: Ingredient

Resource Ingredient "5acc6759-a7f7-4380-ab2e-ad72e8587598"

Profile: Ingredient (ePI)

identifier: id: 70097M6I30 (OFFICIAL)

status: ACTIVE

for: ManufacturedItemDefinition/23fed712-2d60-461d-83a6-5fb939b2a939

role: Excipient (#100000072082)

Manufacturers

-	Manufacturer
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substance

---

15. 5f2c1669-3991-4cc2-b252-958b738d5df8/{3}

Generated Narrative: Ingredient

Resource Ingredient "5f2c1669-3991-4cc2-b252-958b738d5df8"

Profile: Ingredient (ePI)

identifier: id: A2I8C7HI9T (OFFICIAL)

status: ACTIVE

for: ManufacturedItemDefinition/23fed712-2d60-461d-83a6-5fb939b2a939

role: Excipient (#100000072082)

Manufacturers

-	Manufacturer
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substance

---

16. 0c81c330-cf57-45c2-9ca2-559aea4c8060/{3}

Generated Narrative: Ingredient

Resource Ingredient "0c81c330-cf57-45c2-9ca2-559aea4c8060"

Profile: Ingredient (ePI)

identifier: id: 30IQX730WE (OFFICIAL)

status: ACTIVE

for: ManufacturedItemDefinition/23fed712-2d60-461d-83a6-5fb939b2a939

role: Excipient (#100000072082)

Manufacturers

-	Manufacturer
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substance

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17. 6708560e-135d-4b2a-afde-9e3b03f27939/{3}

Generated Narrative: Ingredient

Resource Ingredient "6708560e-135d-4b2a-afde-9e3b03f27939"

Profile: Ingredient (ePI)

identifier: id: 6OZP39ZG8H (OFFICIAL)

status: ACTIVE

for: ManufacturedItemDefinition/23fed712-2d60-461d-83a6-5fb939b2a939

role: Excipient (#100000072082)

Manufacturers

-	Manufacturer
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substance

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Generated Narrative: Ingredient

Resource Ingredient "733fb580-1139-4188-aff8-ad6efe243555"

Profile: Ingredient (ePI)

identifier: id: 532B59J990 (OFFICIAL)

status: ACTIVE

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role: Excipient (#100000072082)

Manufacturers

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substance

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Generated Narrative: Ingredient

Resource Ingredient "c5a3cb57-3f3e-4309-ae34-0926300de57e"

Profile: Ingredient (ePI)

identifier: id: C151H8M554 (OFFICIAL)

status: ACTIVE

for: ManufacturedItemDefinition/23fed712-2d60-461d-83a6-5fb939b2a939

role: Excipient (#100000072082)

Manufacturers

-	Manufacturer
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substance

---

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Generated Narrative: Ingredient

Resource Ingredient "16dc4148-5296-4f7a-8576-2e6bf9dde736"

Profile: Ingredient (ePI)

identifier: id: ETJ7Z6XBU4 (OFFICIAL)

status: ACTIVE

for: ManufacturedItemDefinition/23fed712-2d60-461d-83a6-5fb939b2a939

role: Excipient (#100000072082)

Manufacturers

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substance

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Generated Narrative: Ingredient

Resource Ingredient "b254f961-61ca-43f9-b3f9-5b0b5d4406a9"

Profile: Ingredient (ePI)

identifier: id: 5856J3G2A2 (OFFICIAL)

status: ACTIVE

for: ManufacturedItemDefinition/23fed712-2d60-461d-83a6-5fb939b2a939

role: Excipient (#100000072082)

Manufacturers

-	Manufacturer
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substance

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22. 854be59d-070a-44d7-a82e-bbb83200dc6a/{3}

Generated Narrative: Ingredient

Resource Ingredient "854be59d-070a-44d7-a82e-bbb83200dc6a"

Profile: Ingredient (ePI)

identifier: id: 15FIX9V2JP (OFFICIAL)

status: ACTIVE

for: ManufacturedItemDefinition/23fed712-2d60-461d-83a6-5fb939b2a939

role: Excipient (#100000072082)

Manufacturers

-	Manufacturer
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substance

---

23. 17c536c9-efd1-4427-a7b0-1bcdc266798f/{3}

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "17c536c9-efd1-4427-a7b0-1bcdc266798f"

Profile: SubstanceDefinition (ePI)

identifier: id: NY22HMQ4BX (OFFICIAL)

version: 39

status: Validated (UNII) (#1)

description: White to yellowish white It is a powder of. N ,N -Slightly soluble in dimethylformamide and tetrahydroflan, slightly soluble in methanol and ethanol (95), sparingly soluble in acetonitrile, and practically insoluble in water.

manufacturer: Organization/85c5d81e-9d5a-4a15-8b9d-42bbbe0409c8 "PHARMACIA & UPJOHN COMPANY LLC"

MolecularWeights

-	Type	Amount
*	exact ()	296.4

Structures

-	MolecularFormula
*	C20H24O2

Names

-	Name	Type
*	(+)-6-methyleneandrosta-1,4-diene-3,17-dione	Chemical Name (#1)