Norvipren

Primær information

Handelsnavn:
Norvipren 200 mikrogram resoribletter, sublinguale

Aktiv bestanddel:
BUPRENORPHINHYDROCHLORID

Tilgængelig fra:
Orifarm A/S

ATC-kode:
N02AE01

INN (International Name):
buprenorphine

Dosering:
200 mikrogram

Lægemiddelform:
resoribletter, sublinguale

Brugt til:
Mennesker

Medicin typen:
Allopatiske stof

Dokumenter

for den brede offentlighed:
Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

Anmode informationsbrochure for offentligheden.

for sundhedspersonale:
Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

Anmode informationsbrochure for sundhedspersonale.

Lokation

Fås i:
Danmark

Sprog:
dansk

Andre oplysninger

Status

Kilde:
Lægemiddelstyrelsen - Danish Medicines Agency

Autorisationsnummer:
56169

Sidste ændring:
22-02-2018

Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

Anmode informationsbrochure for offentligheden.

Adgang til dette dokument er kun tilgængelig for registrerede brugere.

Tilmeld dig nu for fuld adgang

6-3-2018

Human medicines European public assessment report (EPAR): Zubsolv, buprenorphine / naloxone, Revision: 1, Authorised

Europe - EMA - European Medicines Agency

12-1-2018

Human medicines European public assessment report (EPAR): Zubsolv, buprenorphine / naloxone, Revision: 0, Authorised

Europe - EMA - European Medicines Agency

1-12-2017

Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA’s efforts to promote more widespread innovation and access to opioid addiction treatments

Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA’s efforts to promote more widespread innovation and access to opioid addiction treatments

FDA - U.S. Food and Drug Administration

1-12-2017

FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder

FDA - U.S. Food and Drug Administration

20-9-2017

FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks

Based on our additional review, the U.S. Food and Drug Administration (FDA) is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction usually outweighs these risks. Careful medication management by health care professionals can reduce...

FDA - U.S. Food and Drug Administration

20-9-2017

Opioid Addiction Medications in Patients Taking Benzodiazepines or CNS Depressants: Drug Safety Communication - Careful Medication Management Can Reduce Risks

Health care professionals should develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants.

FDA - U.S. Food and Drug Administration

15-9-2017

Pending EC decision: Zubsolv, buprenorphine / naloxone, Opinion date: 14-Sep-2017

Europe - EMA - European Medicines Agency

24-7-2017

Opinion/decision on a Paediatric investigation plan (PIP): -, Buprenorphine (hydrochloride), Therapeutic area: Psychiatry

Europe - EFSA - European Food Safety Authority EFSA Journal

3-4-2018

BUPRENORPHINE AND NALOXONE Tablet [Actavis Pharma, Inc.]

Updated Date: Apr 3, 2018 EST

US - DailyMed

7-3-2018

BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet [Amneal Pharmaceuticals LLC]

Updated Date: Mar 7, 2018 EST

US - DailyMed

5-3-2018

BUNAVAIL (Buprenorphine And Naloxone) Film [BioDelivery Sciences International, Inc.]

Updated Date: Mar 5, 2018 EST

US - DailyMed

28-2-2018

BUPRENEX (Buprenorphine Hydrochloride) Injection [Reckitt Benckiser Pharmaceuticals Inc ]

Updated Date: Feb 28, 2018 EST

US - DailyMed

26-2-2018

SUBLOCADE (Buprenorphine) Solution [Indivior Inc.]

Updated Date: Feb 26, 2018 EST

US - DailyMed

14-2-2018

BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet [REMEDYREPACK INC.]

Updated Date: Feb 14, 2018 EST

US - DailyMed

14-2-2018

SIMBADOL (Buprenorphine) Injection [Zoetis Inc.]

Updated Date: Feb 14, 2018 EST

US - DailyMed

13-2-2018

BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet [AvPAK]

Updated Date: Feb 13, 2018 EST

US - DailyMed

12-2-2018

Subutex (Buprenorphine) - updated on RxList

6-2-2018

BUTRANS (Buprenorphine) Patch, Extended Release [Purdue Pharma LP]

Updated Date: Feb 6, 2018 EST

US - DailyMed

2-2-2018

BUPRENORPHINE HCL Tablet [West-Ward Pharmaceuticals Corp.]

Updated Date: Feb 2, 2018 EST

US - DailyMed

2-2-2018

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE Tablet [West-Ward Pharmaceuticals Corp]

Updated Date: Feb 2, 2018 EST

US - DailyMed

30-1-2018

BUPRENORPHINE AND NALOXONE (Buprenorphine Hydrochloride And Naloxone Hydrochloride) Tablet [Golden State Medical Supply, Inc.]

Updated Date: Jan 30, 2018 EST

US - DailyMed

19-1-2018

BUPRENORPHINE Patch [Lake Erie Medical DBA Quality Care Products LLC]

Updated Date: Jan 19, 2018 EST

US - DailyMed

19-1-2018

BUPRENORPHINE HYDROCHLORIDE Tablet [REMEDYREPACK INC.]

Updated Date: Jan 19, 2018 EST

US - DailyMed

19-1-2018

BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet [AvKARE, Inc.]

Updated Date: Jan 19, 2018 EST

US - DailyMed

19-1-2018

BUPRENORPHINE AND NALOXONE Tablet [Sun Pharmaceutical Industries Limited ]

Updated Date: Jan 19, 2018 EST

US - DailyMed

8-1-2018

BUPRENORPHINE HYDROCHLORIDE Injection, Solution [American Regent, Inc.]

Updated Date: Jan 8, 2018 EST

US - DailyMed

8-1-2018

BUPRENORPHINE AND NALOXONE (Buprenorphine Hydrochloride And Naloxone Hydrochloride) Tablet [Bryant Ranch Prepack]

Updated Date: Jan 8, 2018 EST

US - DailyMed

2-1-2018

BUPRENORPHINE Tablet [Bryant Ranch Prepack]

Updated Date: Jan 2, 2018 EST

US - DailyMed

26-12-2017

BUPRENORPHINE AND NALOXONE (Buprenorphine Hydrochloride And Naloxone Hydrochloride) Tablet [Hi-Tech Pharmacal Co. Inc.]

Updated Date: Dec 26, 2017 EST

US - DailyMed

22-12-2017

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE Tablet [SpecGx LLC]

Updated Date: Dec 22, 2017 EST

US - DailyMed

21-12-2017

BUPRENORPHINE HYDROCHLORIDE Tablet [A-S Medication Solutions]

Updated Date: Dec 21, 2017 EST

US - DailyMed

20-12-2017

BUPRENORPHINE HYDROCHLORIDE Tablet [Hi-Tech Pharmacal Co., Inc.]

Updated Date: Dec 20, 2017 EST

US - DailyMed

19-12-2017

BUPRENORPHINE AND NALOXONE (Buprenorphine Hydrochloride Naloxone Hydrochloride Dihydrate) Tablet [Gemini Laboratories, LLC]

Updated Date: Dec 19, 2017 EST

US - DailyMed

18-12-2017

BUPRENORPHINE Patch, Extended Release [Lake Erie Medical DBA Quality Care Products LLC]

Updated Date: Dec 18, 2017 EST

US - DailyMed

15-12-2017

BELBUCA (Buprenorphine Hydrochloride) Film [Endo Pharmaceuticals, Inc.]

Updated Date: Dec 15, 2017 EST

US - DailyMed

8-12-2017

Sublocade (Buprenorphine Injection for Subcutaneous Use) - new on RxList

14-11-2017

Zubsolv (Mundipharma Corporation Limited)

Zubsolv (Active substance: buprenorphine / naloxone) - Centralised - Authorisation - Commission Decision (2017)7640 of Tue, 14 Nov 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/4407

Europe -DG Health and Food Safety

24-10-2017