Editing Dolutegravir/rilpivirine
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Content that violates any copyrights will be deleted. Encyclopedic content must be verifiable through citations to reliable sources.
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| DailyMedID = Juluca |
| DailyMedID = Juluca |
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| pregnancy_AU = B1 |
| pregnancy_AU = B1 |
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| pregnancy_AU_comment = <ref name="Drugs.com pregnancy">{{cite web | title=Dolutegravir / rilpivirine (Juluca) Use During Pregnancy | website=Drugs.com | date=7 January 2020 | url=https://www.drugs.com/pregnancy/dolutegravir-rilpivirine.html | access-date=25 March 2020 |
| pregnancy_AU_comment = <ref name="Drugs.com pregnancy">{{cite web | title=Dolutegravir / rilpivirine (Juluca) Use During Pregnancy | website=Drugs.com | date=7 January 2020 | url=https://www.drugs.com/pregnancy/dolutegravir-rilpivirine.html | access-date=25 March 2020}}</ref><ref name="Juluca AU PI" /> |
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| pregnancy_category= |
| pregnancy_category= |
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| routes_of_administration = [[Oral administration|By mouth]] |
| routes_of_administration = [[Oral administration|By mouth]] |
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<!-- Legal status --> |
<!-- Legal status --> |
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| legal_AU = S4 |
| legal_AU = S4 |
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| legal_AU_comment = <ref>{{cite web | title=Juluca | website=NPS MedicineWise | date=15 July 2021 | url=https://www.nps.org.au/medicine-finder/juluca#full-pi | access-date=13 February 2022 |
| legal_AU_comment = <ref>{{cite web | title=Juluca | website=NPS MedicineWise | date=15 July 2021 | url=https://www.nps.org.au/medicine-finder/juluca#full-pi | access-date=13 February 2022}}</ref><ref name="Juluca AU PI">{{cite web | url=http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2018-PI-01956-1 | title=TGA eBS - Product and Consumer Medicine Information Licence }}</ref> |
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| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F--> |
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F--> |
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| legal_BR_comment = |
| legal_BR_comment = |
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| legal_CA = Rx-only |
| legal_CA = Rx-only |
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| legal_CA_comment = <ref>{{cite web | url=https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00438 | title=Regulatory Decision Summary for Juluca | website=Drug and Health Product Register | date=23 October 2014 |
| legal_CA_comment = <ref>{{cite web | url=https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00438 | title=Regulatory Decision Summary for Juluca | website=Drug and Health Product Register | date=23 October 2014 }}</ref><ref>{{cite web | title=Drug and medical device highlights 2018: Helping you maintain and improve your health | website=[[Health Canada]] | date=14 October 2020 | url=https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2018.html | access-date=17 April 2024}}</ref> |
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| legal_DE = <!-- Anlage I, II, III or Unscheduled--> |
| legal_DE = <!-- Anlage I, II, III or Unscheduled--> |
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| legal_DE_comment = |
| legal_DE_comment = |
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| legal_NZ_comment = |
| legal_NZ_comment = |
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| legal_UK = POM |
| legal_UK = POM |
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| legal_UK_comment = <ref>{{cite web | title=Juluca 50 mg/25 mg film-coated tablets - Summary of Product Characteristics (SmPC) | website=(emc) | date=25 February 2020 | url=https://www.medicines.org.uk/emc/product/9246/smpc | access-date=25 March 2020 |
| legal_UK_comment = <ref>{{cite web | title=Juluca 50 mg/25 mg film-coated tablets - Summary of Product Characteristics (SmPC) | website=(emc) | date=25 February 2020 | url=https://www.medicines.org.uk/emc/product/9246/smpc | access-date=25 March 2020}}</ref> |
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| legal_US = Rx-only |
| legal_US = Rx-only |
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| legal_US_comment = <ref name="Juluca FDA label" /> |
| legal_US_comment = <ref name="Juluca FDA label" /> |
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The most common adverse reactions (of all severity grades) are [[diarrhea]] and headache.<ref name="Juluca FDA label" /> |
The most common adverse reactions (of all severity grades) are [[diarrhea]] and headache.<ref name="Juluca FDA label" /> |
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Dolutegravir/rilpivirine was approved for use in the United States in November 2017,<ref name="Juluca FDA label">{{cite web | title=Juluca- dolutegravir sodium and rilpivirine hydrochloride tablet, film coated | website=DailyMed | date=24 October 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=806653d1-bf35-4924-b999-ad5d21821cc1 | access-date=25 March 2020 |
Dolutegravir/rilpivirine was approved for use in the United States in November 2017,<ref name="Juluca FDA label">{{cite web | title=Juluca- dolutegravir sodium and rilpivirine hydrochloride tablet, film coated | website=DailyMed | date=24 October 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=806653d1-bf35-4924-b999-ad5d21821cc1 | access-date=25 March 2020}}</ref><ref>{{cite web | title=Drug Approval Package: Juluca (dolutegravir and rilpivirine) | website=U.S. [[Food and Drug Administration]] (FDA) | date=29 June 2018 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/210192Orig1s000TOC.cfm | access-date=25 March 2020}}</ref><ref>{{cite web | title=Juluca: FDA-Approved Drugs | website=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210192 | access-date=25 March 2020}}</ref> and for use in the European Union in May 2018.<ref name="Juluca EPAR">{{cite web | title=Juluca EPAR | website=[[European Medicines Agency]] (EMA) | date=11 February 2019 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/juluca | access-date=25 March 2020}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> |
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